IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN ... · 2016, with a list of witnesses, exhibits...

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

IN RE: TYLENOL® (ACETAMINOPHEN) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION

)) ) ) )

JUDGE LAWRENCE STENGEL MDL No. 2436

This Document Relates to:

RANA TERRY, AS PERSONAL ADMINISTRATOR OF THE ESTATE OF DENICE HAYES, DECEASED Plaintiff, v. MCNEIL-PPC, INC., MCNEIL CONSUMER HEALTHCARE, AND JOHNSON & JOHNSON, Defendants.

)) ) ) ) ))) ) ) ) ) ) )

Member Action No. 2:12-cv-07263

______________________________________________________________________________

DEFENDANTS’ MEMORANDUM REGARDING FINAL PRETRIAL ORDER ______________________________________________________________________________

Defendants McNEIL-PPC, Inc. (“McNeil”) and Johnson & Johnson (“J&J”)

(“Defendants”)1 submit this Memorandum in accordance with the Court’s modification of Case

Management Order 18(i) during the July 13, 2016, telephonic conference with the parties.2

1 This Memorandum is filed on behalf of McNEIL-PPC, Inc., including its McNeil Consumer Healthcare Division. That Division is an unincorporated division and not a legal entity and therefore is not properly named as a separate defendant. Effective June 29, 2015, McNEIL-PPC, Inc. changed its name to Johnson & Johnson Consumer Inc.

2 During the July 13, 2016, telephone conference, the Court relieved the parties of submission of a formal pre-trial order as contained in CMO-18(i) and the Local Rules of the Eastern District of Pennsylvania. Instead, the parties are to submit a memorandum to the Court by August 24, 2016, with a list of witnesses, exhibits (including stipulation of authenticity), and a trial brief to the extent legal issues are expected to arise at trial, without narrative.

Case 2:12-cv-07263-LS Document 274 Filed 08/24/16 of 5

2

In accordance with the Court’s instruction, Defendants provide the following:

I. WITNESS LIST

Defendants attach their Witness List as Exhibit A.

II. EXHIBIT LIST

Defendants attach their Exhibit List as Exhibit B.

III. LEGAL ISSUES

Defendants believe the key legal issues have been briefed and ruled on by prior Orders of

this Court. Defendants reserve all objections and will submit Trial Briefs at appropriate times,

should legal issues requiring additional authority or briefing arise during trial.

Defendants object to Plaintiff’s August 23, 2016 submission in several respects. As

outlined in the attached letter to the Court, Defendants request an opportunity to submit a written

response to the improper issues raised in Plaintiff’s submission and to orally argue and address

these issues with the Court at the Case Management Conference on September 7, 2016.

IV. PRETRIAL MATTERS: LENGTH OF TRIAL AND EMPANELING OF JURY

Finally, Defendants offer two points for consideration regarding the anticipated length of

trial and the number of empaneled jurors.

First, Plaintiff estimates that trial will last 4-5 weeks. Defendants believe that is not a

realistic estimate in light of the significant hours of video deposition testimony designated by

Plaintiff alone, coupled with the daily trial schedule and allocated days when trial will not be

held. Defendants instead believe that 6-7 weeks is more likely.

Second, in light of that estimate, and the complexity of the case—from the standpoint of

necessary factual testimony from the Plaintiff, Ms. Hayes’s family, and treating physicians;

expert testimony on general and specific causation from a medical standpoint; and testimony on

the Extra Strength Tylenol® labeling, including its regulatory history— Defendants believe that


3

empaneling 10 jurors is more appropriate to allow for possible vacancies that may occur during

the course of trial. Empaneling 10 jurors is also consistent with Local Rule 48.1, which provides

that

Whenever it appears likely that the trial will be unusually protracted, or whenever the court in its discretion determines that the interests of justice so require, the jury may be enlarged to include as many as twelve (12) members, and any number of alternates may be used, as the court may determine; but not more than twelve (12) persons shall participate in the deliberation of the jury, nor may any verdict be rendered by a jury consisting of more than twelve (12) persons, or fewer than six (6) persons.

L.R. 48.1(b)(2); see also L.R. 48.1(b)(1) (mistrial shall be declared if the number of jurors falls

below six). Indeed, under this rule, the Court could choose to empanel more than 12 jurors to

ensure that the number of jurors will not fall below the minimum of six (thus mandating a

mistrial), so long as no more than 12 deliberate. Given the circumstances of this case,

Defendants believe that 10 jurors is the minimum number that should be empaneled to ensure

that the requisite number of jurors remain on the panel and can ultimately deliberate.

In addition, the Court may wish to revisit this issue based on the answers to the Juror

Questionnaire; if there are several venire members who seek to be excused for hardship, this may

be an indicator that an even greater number of jurors should be empaneled to account for

dismissals.


4

V. CONCLUSION

Defendants look forward to discussing issues raised in the parties’ submissions with the

Court on September 7, 2016, and thank the Court for its attention to these matters.

This, the 24th day of August, 2016.

/s/ Michael B. Hewes Michael B. Hewes (MS No. 100089) BUTLER SNOW LLP 1300 25th Ave., Suite 204 Gulfport, MS 39501 Telephone: (228) 575-3039 Facsimile: (228) 868-1531 E-Mail: [email protected] Attorney for Defendants Johnson & Johnson and McNEIL-PPC, Inc.

OF COUNSEL: Christy D. Jones, Esquire Alyson B. Jones, Esquire BUTLER SNOW LLP 1020 Highland Colony Parkway, Suite 1400 Ridgeland, MS 39157 Tel: (601) 985- 4523 Tel: (601) 985-4427 Fax: (601) 985-4500 [email protected] [email protected] David F. Abernethy PA Attorney No. 36666 DRINKER BIDDLE & REATH LLP One Logan Square, Suite 2000 Philadelphia, PA 19103-6996 (215) 988-2700 [email protected]


5

CERTIFICATE OF SERVICE

I hereby certify that on the 24th day of August, 2016, a true and correct copy of the

foregoing document was filed through the Court’s Electronic Case Filing system. Notice of this

filing will be sent electronically to registered participants as identified on the Notice of

Electronic Filing.

s/ Michael B. Hewes Michael B. Hewes


Exhibit A

Case 2:12-cv-07263-LS Document 274-1 Filed 08/24/16 Page 1 of 6

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

IN RE: TYLENOL® (ACETAMINOPHEN) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION

)) ) ) ) )

JUDGE LAWRENCE STENGEL MDL No. 2436

This Document Relates to:

RANA TERRY, AS PERSONAL ADMINISTRATOR OF THE ESTATE OF DENICE HAYES, DECEASED Plaintiff, v. MCNEIL-PPC, INC., MCNEIL CONSUMER HEALTHCARE, AND JOHNSON & JOHNSON, Defendants.

)) ) ) ) ))) ) ) ) ) ) )

Member Action No. 2:12-cv-07263

DEFENDANTS’ WITNESS LIST

Pursuant to Federal Rule of Civil Procedure 26(a)(3)(A)(i) and the Court’s February 29, 2016

Case Management Order 18(i) (Dkt. No. 194), Defendants McNeil-PPC, Inc. (“McNEIL”) and

Johnson & Johnson (“J&J”) hereby submits the list of witnesses Defendants may call live or by

deposition at the trial of the above-captioned action

1. Abhinandana Anantharaju, MD (Video) 1120 S. Jackson Highway, Suite #201 Sheffield, AL 35660

2. Jeffrey Brent, M.D. (Live) Toxicology Associates 2555 S. Downing Street, Suite 260 Denver, Colorado 80210


2

3. Robert Brown (Live) Center for Liver Disease and Transplantation Columbia University Medical Center 622 West 168 Street, PH 14 East Room 105 New York, NY 10032

4. Lawrence Carmichael, MD (Video)

1111 South Raleigh Avenue Sheffield, AL 35660

5. Sherrie Cathcart (Video)

1001 N Fairfax St #400 Alexandria, VA 22314

6. Steven Flamm, M.D. (Live) Northwestern University Feinberg School of Medicine Division of Hepatology 676 N. St. Clair St., Suite 19-046 Chicago, Illinois 60611

7. Gordon Sze, M.D. (Live) Department of Diagnostic Radiology Yale University School of Medicine 333 Cedar Street New Haven, CT 06519

8. Alan Jones, M.D. (Live) University of Mississippi Medical Center Department of Emergency Medicine 2500 North State Street Jackson, Mississippi 39216

9. Ed Kuffner, M.D. (Live or Video) 1409 Florence Drive Gwynedd Valley, PA 19437

10. Anne M. Larson, MD (Video)

Swedish Medical Center 1124 Columbia Street #600 Seattle, WA 98104-1321

11. William Lee, MD (Video)

University of Texas Southwestern Medical Center 5959 Harry Hines Blvd. Dallas, TX 75390


3

12. Judith Jones, MD, PhD (Live or Video) The Degge Group, Ltd. 9302 Lee Highway, Suite 700 Fairfax, VA 22031

13. Lynn Pawelski (Live or Video) 3299 Lancashire Road Furlong, PA 18925

14. Patricia Robuck, Ph.D. (Video)

222 Percheron Ct. Gambrills, MD 21054

15. Rex Sherer, MD (Video) 687 Barkley Circle Alabaster, AL 35007

16. Anthony Temple, M.D. (Live or Video) 1027 Wesley Powell Drive St. George, UT 84790

17. Rana Terry (Live)

7296 County Line Rd. Leighton, AL 35646

18. Rebecca Hayes (Live) 7298 County Line Rd. Leighton, AL 35646

19. Any witness disclosed on the witness list of any other party.

Defendants reserve the right to supplement or amend its witness list and call witnesses

not included on this list based upon any rulings of the Court or any other Court decisions that

affect the scope of evidence in this trial or if Plaintiff alters or amends her witness list. By

reserving the right to call witnesses identified by Plaintiff, and identifying the witnesses above,

Defendants do not intend to waive any of its objections to deposition testimony, exhibits, or

other evidence or argument.

Defendants further reserve the right to call any of Ms. Hayes’ treating physicians or other

health care providers should their testimony become necessary at trial. Defendants also may call


4

one or more impeachment witnesses at trial and will identify such witnesses at the appropriate

time at trial. Defendants further reserve the right to supplement this list and/or to elicit testimony

from witnesses not identified herein, depending upon the evidence adduced at trial and/or in

response to testimony provided by plaintiff’s witnesses. Defendants further reserve the right to

call any of the above witnesses or any other witnesses for authentication and/or rebuttal

purposes.

Defendants also reserve the right to supplement this witness list and call additional

witnesses not included on this list who become known to Defendants in response to or in

furtherance of issues not currently apparent. Defendants also reserve the right to supplement this

list with witnesses who have been identified in discovery responses and witnesses who may be

identified in future discovery as having relevant information and/or knowledge. Defendants also

reserve the right to call necessary document custodian witnesses to authenticate records.

Defendants also reserve the right to supplement its witness list to include witnesses

whose depositions are taken hereafter or for which transcripts have not yet been received. This

witness list does not include those witnesses for whom Defendants would seek to introduce a

counter-designation of prior testimony if Plaintiff seeks to introduce prior testimony from the

same witness. Lastly, Defendants also reserve the right to present additional witnesses at trial by

deposition, wherein deposition designations will be submitted in accordance with the Order of

this Court.

Submitted, this the 29th day of July, 2016.

s/ Christy D. Jones Christy D. Jones Alyson Jones Admitted Pro Hac Vice Butler Snow LLP 1020 Highland Colony Parkway, Suite 1400


5

Ridgeland, MS 39157 (601) 985-4523 David F. Abernethy PA Attorney No. 36666 DRINKER BIDDLE & REATH LLP One Logan Square, Suite 2000 Philadelphia, PA 19103-6996 (215) 988-2700 Attorneys for Defendants Johnson & Johnson and McNEIL-PPC, Inc.

32119089v1


Exhibit B


Exhibit Bates Range (if applicable) Document Date Description Offered Date Admitted Date

D00000001 TYLNJ 04325637 4/13/1955 Letter to FDA regarding NDA 9-927

D00000002 TYLNJ 04325261-459 4/13/1955 Tylenol Acetaminophen Elixir, NDA 9-927, Annual Report

D00000003 TYLNJ 04325619 6/3/1955 Letter from FDA approving NDA 9-927

D00000004 TYLNJ 04325615-18 6/10/1955 Letter to FDA regarding NDA 9-927

D00000005

TYLREP00178401-2

8/5/1958 Letter to FDA enclosing submission of NDA 11-630, Tylenol 325mg tablets

D00000006 TYLNJ 04315532 9/29/1958 Letter from FDA regarding NDA 11-630


D00000008 TYLNJ 04315520-24 3/9/1959 Letter from FDA regarding NDA 11-360


D00000010 TYLNJ 04315510-12 8/5/1960 Letter to FDA regarding Tylenol

D00000011 TYLNJ 04315508-09 9/12/1960 Letter from FDA approving NDA 11-630

D00000012 TYLNJ 04315506-07 4/14/1961 Letter to FDA regarding McNeil Labs, Inc.

D00000013 00/00/1962 1962 Kefauver-Harris Amendment; public law 87-781

D00000014 00/00/1964 US Department of Health, Education, and Welfare. Surgeon General's Advisory Committee on Smoking. (1964). Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service (No. 1103).

D00000015

TYLNJ 04315482-83

4/21/1966 Memorandum from R. Leininger regarding Tylenol tablets

D00000016 TYLNJ 04315456-57 7/24/1969 Memorandum from P. Seay regarding FDA inspection

D00000017 TYLNJ 04295423-24 5/27/1970 Letter from FDA regarding IND 6866

D00000018 TYLNJ 03444626;TYLNJ 03444632-635

6/15/1971 Letter to FDA regarding NDA 17-053


D00000020 TYLNJ 04273846-47 10/15/1971 Memorandum from P. Seay regarding NDA 17-053

D00000021 TYLNJ 06449304 11/9/1971 Memorandum from P. Seay regarding Tylenol 500mg

D00000022 TYLNJ 04315433-36 12/3/1971 Memorandum from P. Seay regarding Tylenol



D00000025 00/00/1972 Advisory Review Panel for OTC internal analgesic and antiheumatic products

D00000026 1/5/1972 37 Fed. Reg. 85




D00000030 TYLNJ 04273787-89 4/3/1972 Memorandum from FDA regarding NDA 17-053

D00000031 TYLNJ 04315379 4/14/1972 Letter from FDA regarding NDA 9-927, NDA 11-630

D00000032 4/20/1972 37 Fed. Reg. 7807

D00000033 5/11/1972 37 Fed. Reg. 9464

D00000034TYLNJ 03449260-61 6/15/1972

Seay memo regarding FDA/McNeil meeting on 5/10/72 regarding Tylenol-500 capsules.

TYLENOL MASTER EXHIBIT LIST - PART A


D00000035 7/21/1972 37 Fed. Reg. 14633

D00000036 TYLNJ 04325606 10/26/1972 Letter from FDA regarding Tylenol

D00000037 TYLNJ 04273750-54;TYLNJ 04315366-70

11/21-22/1972 Summary of Minutes of OTC FDA Panel on Internal Analgesics, Including Antirheumatic Drugs

D00000038 TYLNJ 04273783 12/19/1972 Letter to FDA regarding NDA 17-053D00000039 TYLNJ 04273776-77 2/12/1973 Memorandum from P. Seay regarding NDA 17-053D00000040 TYLNJ 04273758-60 5/15/1973 Letter from FDA regarding NDA 17-053D00000041 TYLNJ 04315363 6/7/1973 Letter to FDA regarding Tylenol D00000042 TYLNJ 04315358-59 6/8/1973 Memorandum from P. Seay regarding TylenolD00000043 TYLNJ 04315360-61 7/17/1973 Memorandum from P. Seay regarding TylenolD00000044 TYLNJ 04315357 8/1/1973 Letter to FDA regarding Tylenol D00000045 TYLNJ 04273739-44 10/2/1973 Letter to FDA regarding NDA 17-053D00000046 TYLNJ 04274460 12/18/1973 Letter to FDA enclosing submission of NDA 17-552




D00000050

TYLNJ 04315299-302


D00000051 TYLNJ 04315264 3/20/1974 Letter to FDA regarding Tylenol


D00000053 3/29/1974 21 CFR 330.10

D00000054

TYLNJ 04273656-70



D00000056

TYLNJ 04315272-285

5/7/1974 Letter to FDA regarding OTC Panel on Internal Analgesics

D00000057

TYLNJ 04273678-79


D00000058 TYLNJ 04274455-56;TYLNJ 04315262

5/29/1974 Letter to McNeil Laboratories, Inc. regarding dosage

D00000059 TYLNJ 04274454;TYLNJ 04315261



D00000061

TYLNJ 04274465



D00000063 TYLNJ 04315297-98 9/25-26/1974 Meeting of the FDA’s OTC Panel on Internal Analgesics D00000064 TYLNJ 04315303-04 9/26/1974 Letter to FDA regarding NDA 11-630


D00000066 TYLNJ 04315289 10/28/1974 Memorandum from P. Seay regarding Tylenol






D00000072 TYLNJ 04273629 7/21/1975 Letter to FDA regarding 17-053/S-0001


D00000073 TYLNJ 04099822;TYLNJ 04274479-83

7/22/1975 Letter from FDA approving NDA 17-552

D00000074 TYLNJ 04274451 7/28/1975 Letter to FDA regarding NDA 17-552/S-001


D00000076 There is no Exhibit


D00000078 TYNJ 00567652-668 8/0/1975 White Paper – Symptoms and treatment of overdosage of selected McNeil products

D00000079 TYLNJ 04274120 8/6/1975 Letter from FDA regarding 17-053/S-0001





D00000084 TYLNJ 04274111 10/20/1975 Letter from FDA approving NDA 17-053/S-001


D00000086

TYLNJ 04274107

12/2/1975 Letter from FDA approving NDA 17-053/S-002, S-003, S-004



D00000089 TYLNJ 04274443 1/30/1976 Letter from FDA regarding NDA 17-552/S-002

D00000090 TYLNJ 04274435-39 2/9/1976 Letter to FDA regarding 500mg Products

D00000091 2/11/1976 Letter to FDA regarding NDA 17-552/S-003





D00000096 TYLNJ 04274429 3/10/1976 Letter from FDA regarding 500mg Products

D00000097 TYLNJ 03384950-955 3/12/1976 Memo from R Steelman re Acetaminophen Safety Task Force Meeting.




D00000101

TYLNJ 04274077-84

5/26/1976 FDA Memo regarding Summary for Basis of Approval of NDA 17-756



D00000104 10/8/1976 Re Tylenol from Patrick Seay

D00000105 10/11/1976 Re Tylenol acetaminophen from Patrick Seay

D00000106 TYLNJ 03452634 10/11/1976 McNeil submission to FDA re: SNDA, 17-053/S-005

D00000107TYLNJ 04274421

10/20/1976 or 10/26/1976

McNeil letter to FDA re: OTC Review Panel, NDA 17-552

D00000108 TYLNJ 04274412-13 10/23/1976 McNeil Message to Physicians

D00000109 TYLNJ 03472876 11/1/1976 Re: Tylenol acetaminophen

D00000110 11/11/1976 IND FD 1571, Acetylcysteine, NDA 11-630

D00000111 11/11/1976 Letter from Patrick Seay



D00000113 11/22/1976 Meeting between McNeil & FDA re: clinical studies

D00000114 TYLNJ 04274076 11/22/1976 FDA approval of SNDA, NDA 17-053/S-005

D00000115 12/1/1976 McNeil Memo to Distribution

D00000116 TYLNJ 04274415-16 12/18/1976 McNeil letter to FDA re: study protocol

D00000117TYLNJ 04325594 1/27/1977

Letter to FDA regarding NDA 11-630, NDA 17-552, NDA 17-053

D00000118 TYLNJ 04274067-69 2/3/1977 McNeil Memo from Patrick Seay re: labeling

D00000119TYLNJ 04274407 6/23/1977

McNeil letter to FDA regarding NDAs 11-630; 99927; 17-552; 17-053; and 17-756

D00000120 TYLNJ 04274406 6/23/1977 McNeil letter to FDA re: Consumer Products Division

D00000121 7/8/1977 42 Fed Reg 35414

D00000122 7/8/1977 42 Fed Reg 35416

D00000123 7/8/1977 42 Fed Reg 35346-494

D00000124 7/8/1977 NPR for the Internal Analgesic, Antipyretic, Antirheumatic (IAAA) Drug Products

D00000125 9/23/1977 Letter from William Madison at McNeil to FDA

D00000126TYLNJ 04274404 10/27/1977

FDA letter re: receipt of McNeil SNDA re: unit dose packaging, NDA 17-552/S-005

D00000127TYLNJ 03452668 11/30/1977

McNeil letter to FDA re: encapsulation of ES Tyl, NDA 17-053/S-006

D0000012812/5/1977

McNeil letter to FDA re: proposed final rule for monograph for internal analgesic

D00000129 12/6/1977 McNeil letter from William Madison to FDA

D00000130 12/8/1977 Letter from FDA to Sterling Drug Company

D00000131 2/6/1978 Reply comments by McNeil to Monograph


D00000133 5/24/1978 Letter from Thomas Gates to Mark Abramowicz



D00000136 6/16/1978 Letter from Thomas Gates to Mark Abramowicz

D00000137 8/2/1978 William Madison to Donald Kilburn Enclosures

D00000138 8/7/1978 McNeil letter from William Madison to FDA

D0000013912/12-13/1978 FDA Meeting re: gastrointestinal drugs advisory committee

D00000140 TYLNJ 03452687 2/13/1979 McNeil submission to FDA re packaging for ES Tyl

D00000141TYLNJ 04274054 3/12/1979 SNDA re: alternative inactive ingredients, NDA 17-053/S-009

D00000142TYLNJ 04274400 3/22/1979

McNeil submission to FDA re: Registration of Drug Establishment

D00000143 TYLNJ 04274042 3/23/1979 McNeil letter to FDA re: distribution, NDA 17-053/S-011

D00000144TYLNJ 04274051 4/2/1979

FDA letter re: receipt of McNeil SNDA re packager, NDA 17-053/S-007

D00000145TYLNJ 04274052 4/2/1979


D00000146TYLNJ 04274053 4/2/1979 FDA letter re: receipt of McNeil SNDA, NDA 17-053/S-009


D00000147TYLNJ 04274399 4/2/1979


D00000148TYLNJ 04274398 4/2/1979


D00000149TYLNJ 04274397 4/2/1979

FDA letter re: receipt of McNeil SNDA re: inactive ingredient, NDA 17-552/S-008

D000001504/9/1979

FDA letter re: receipt of SNDA re: packager, NDA 17-053/S-010

D00000151TYLNJ 04274048 4/12/1979

FDA letter re: receipt of SNDA re: manufacturing, NDA 17-053/S-011

D00000152TYLNJ 04274396 4/9/1979

FDA letter re: receipt of SNDA re: packager, NDA 17-053/S-009

D00000153TYLNJ 04274395 4/9/1979

FDA letter re: receipt of SNDA re: distribution, NDA 17-552/S-010

D00000154TYLNJ 04274047 4/9/1979

FDA letter re: receipt of supplemental application for NDA 17-053

D00000155TYLNJ 03450229 5/29/1979

FDA letter to McNeil re: receipt of communication for NDA 11-630

D00000156 TYLNJ 04274045 6/29/1979 Letter from FDA approving NDA 17-053-S-010








D00000164TYLNJ 04274040-41 9/20/1979 FDA letter requesting info re ingredients, NDA 17-053/S-009

D00000165TYLNJ 04274036 10/5/1979 FDA approval letter re encapsulating firm, NDA 17-053/S-012

D00000166TYLNJ 04274037-39 10/10/1979 McNeil letter to FDA re info requested, NDA 17-053/S-009

D00000167TYLNJ 04274388-89 10/25/1979

FDA letter requiring info re: SNDA application, NDA 17-053/S-009; NDA 17-552/S-008

D00000168TYLNJ 04274346-48 11/8/1979

Letter from McNeil to FDA re: additional info, NDA 17-053/S-009; NDA-552/S-008


D00000170TYLNJ 04274345 11/26/1979

FDA letter re receipt of SNDA supplemental application, NDA 17-053/S-009; NDA 17-552/S-008

D00000171TYLNJ 04315655-720 00/00/1980

Tylenol Regular Strength Tablets, NDA 11-630, Correspondence

D00000172TYLNJ 04274344 1/11/1980 SNDA application re: packaging firm, NDA 17-552/S-011


D00000174 4/1/1980 April 1980 RS Tylenol capsule approval

D00000175TYLNJ 04274342 5/5/1980

FDA letter re: receipt of SNDA application for packaging firm, NDA 17-552/S-011


D00000176 TYLNJ 04274341 5/15/1980 Letter from McNeil re: facility controls

D00000177 TYLNJ 04274340 5/22/1980 Letter from McNeil to FDA re: facility controls

D00000178TYLNJ 04274339 6/4/1980

McNeil letter to FDA re: in vivo bioavailability for ES Tyl, NDA 17-053/S-009; NDA 17-552/S-008

D00000179 7/28/1980 McNeil submits periodic report to FDA, NDA 17-552

D00000180TYLNJ 04274335-37 8/28/1980

FDA letter requesting info re: inactive ingredients, NDA 17-053/S-009; NDA 17-552/S-008

D00000181

TYLNJ 04274386-87 10/23/1980McNeil submission of Addendum #2 to SNDA application to FDA, NDA 17-053/S-009; NDA 17-552/S-008

D00000182TYLNJ 04274384-85 12/16/1980

McNeil letter to FDA Bureau of Drugs re SNDA, NDA 17-053/S-009; NDA 17-552/S-008

D00000183TYLNJ 04274381 2/6/1981

FDA letter re receipt of resubmitted SNDA, NDA 17-552/S-008

D00000184TYLNJ 04274379-80 2/6/1981

McNeil letter to FDA re: Bureau of Drugs consideration for dosing change

D00000185TYLNJ 04274377-78 2/6/1981

McNeil letter to FDA re additional info requested, NDA 17-053/S-009; NDA 17-552/S-008

D00000186

TYLNJ 04274375

4/9/1981 Letter from FDA approving NDA 17-552/S-008, NDA 17-053/S-009

D00000187 TYLNJ 01190188-206 7/1/1981 McNeil Consumer Healthcare Clinical Study Report for Protocol 0-214: A double-dose, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery. Fort Washington, PA: McNeil Consumer Healthcare, July 1981a (data on file).

D00000188 8/23/1981 Rumack publication re: Acetaminophen Overdose

D00000189 TYLNJ 03399990-03400000 9/1/1981 McNeil Consumer Healthcare Clinical Study Report for Protocol 9-123: A phase IV double-blind study of the relative analgesic potency of orally administered Tylenol acetaminophen, aspirin and placebo tablets. Fort Washington, PA: McNeil Consumer Healthcare, September 1981 (data on file).

D00000190 TYLNJ 03381829-34 2/9/1982 US Patent for “Methionine Sulfoxides…”

D00000191TYLNJ 00567408 3/25/1982

Correspondence from Joe Chiesa regarding Duke University/ABC Broadcase 2/21/82

D00000192TYLNJ 04274010 5/5/1982

McNeil letter to FDA re: SNDA for child-resistant packaging, NDA 17-053/S-012

D00000193TYLNJ 04274008-09 5/11/1982

FDA letter re: receipt of McNeil SNDA re: child resistant packaging, NDA 17-053/S-013

D00000194TYLNJ 04274012 7/16/1982

FDA approval letter re SNDA for child resistant packaging, NDA 17-053/S-012

D00000195 TYLNJ 04274003-04 7/27/1982 McNeil Interval Report No. 11NDA 17-053

D00000196 TYLNJ 04273998-99 10/7/1982 FDA letter to McNeil re: recall


D00000197TYLNJ 04273993-94 10/13/1982

McNeil submission to FDA re: checks in areas affected by contamination

D00000198TYLNJ 04273991-92 10/27/1982

FDA letter to McNeil re: acceptance of proposed plan for checks of contaminated areas

D00000199TYLNJ 04273984-85 11/24/1982

McNeil SNDA application for tamper resistant package, NDA 17-053/S-014/015

D00000200TYLNJ 04274372-73 11/24/1982

McNeil SNDA application for tamper resistant package, NDA 17-552/S-012/013

D00000201TYLREP01489464-66 12/3/1982

McNeil letter to FDA re: Cardio-Renal Division re: 18 articles discussing 25 patients

D00000202TYLNJ 04274371 12/6/1982 McNeil memo re: “No Wait” SNDA, NDA 17-053 & 177-552

D00000203TYLNJ 04274369 12/7/1982

FDA receipt of McNeil SNDA re: tamper resistant packaging, NDA 17-053/S-012, S-013

D00000204TYLNJ 04273981-82 12/7/1982

FDA receipt of McNeil SNDA re: tamper resistant packaging, NDA 17-053/S-014

D00000205 12/8/1982 Bachrach submission to FDA

D00000206 TYLNJ 04273979-80 12/16/1982 Letter to FDA re: status report

D00000207 00/00/1983 Pediatric Dosing Schedule developed by McNeil

D00000208 TYLNJ 04274367 2/14/1983 Letter to FDA re: NDA 17-552/S-015






D00000214 TYLNJ 04273975-76 3/7/1983 Letter to FDA re: status report



D00000217 TYLNJ 04273970 3/23/1983 Letter from FDA approving NDA 17-053/S-016, S-017

D00000218 TYLNJ 04274359 4/14/1983 Letter to FDA re: NDA 17-552

D00000219 TYLNJ 04274358 4/18/1983 Letter from FDA re: NDA 17-552/S-016



D00000222 TYLNJ 03382471-74 5/31/1983 Current Topics: Acetaminophen and Alcohol

D00000223 TYLNJ 04273973 7/12/1983 Letter from FDA re: NDA 17-053

D00000224 TYLNJ 04273973 7/12/1983 Letter to FDA re: supplemental NDA 17-053





D00000229 TYLNJ 04325581 8/30/1983 Letter to FDA re: NDA 9927 Annual Report #12

D00000230 TYLNJ 04273962 8/30/1983 Letter to FDA regarding removal of NDA 17-053/S-018




D00000233 10/1/1983 McNeil Consumer Healthcare Clinical Study Report for Protocol 81-229: A phase IV double-blind single dose study of the safety and efficacy of acetaminophen 1000 mg, aspirin 650 mg, and placebo in the treatment of pain following oral surgery. Fort Washington, PA: McNeil Consumer Healthcare, October 1983d (data on file).

D00000234TYLNJ 04273953-54 10/26/1983

Letter to FDA re: Tylenol Capsule Products Final Status Report

D00000235 11/1/1983 McNeil Consumer Healthcare Clinical Study Report for Protocol 2-231: A phase IV double-blind single dose evaluation of the safety and efficacy of acetaminophen 1000 mg, aspirin 650 mg, and placebo in the treatment of pain following oral surgery. Fort Washington, PA: McNeil Consumer Healthcare, November 1983b (data on file).

D00000236TYLNJ 04273951 11/21/1983

Letter from FDA re: market withdrawal of McNeil’s encapsulated products

D00000237 5/4/1984 Letter from FDA

D00000238 TYLNJ 04325579-80 9/25/1984 Letter to FDA re: NDA 9927 Annual Report #13

D00000239 TYLNJ 04273944 & 04274352 9/28/1984 Letter to FDA re: NDA 17-552 Interval Report No. 13

D00000240 TYLNJ 04273942 & 04274351 10/18/1984 Letter to FDA re: NDA 17-053 Changes Being Effected

D00000241 TYLNJ 04273941; TYLNJ 04274350

10/22/1984 Letter from FDA re: NDA 17-053/S-20 & 17-552/S-017

D00000242TYLNJ 04273937-39 12/7/1984

Letter from FDA re: NDA 17-053/S-020 Amendment to Interval Report No. 13



D00000245 TYLNJ 04273937; TYLNJ 04274334

1/14/1985 Letter from FDA re: approval of sNDA 17-053/S-020

D00000246 TYLNJ 04273934; TYLNJ 04274331

2/21/1985Letter to FDA re: NDA 17-053 Additional Manufacturing Facility

D00000247 TYLNJ 04273932; TYLNJ 04274332

2/21/1985 Letter from FDA re: NDA 17-053/S-021 & 17-552/S-018

D00000248TYLNJ 04273936 3/22/1985

Letter from FDA re: NDA 17-053/S-021 Additional Manufacturing Facility


D00000250 TYLNJ 04325577 5/8/1985 Letter from FDA re: Notice of Adverse Findings

D00000251TYLNJ 03479165-78 6/10/1985

Dear Doctor Letter “Current Thinking on the Selection of Nonprescription Analgesics”

D00000252TYLNJ 04325573 6/14/1985 Drug Recall re: Children’s Tylenol® acetaminophen Elixir

D00000253 TYLNJ 04325569-71 7/8/1985 Letter from FDA re: Recall D 417-5

D00000254 TYLNJ 04325567-68 7/18/1985 Letter to FDA re: Drug Recall D 417-5

D00000255 TYLNJ 04325555-56 7/31/1985 Letter to FDA re: Drug Recall D 417-5

D00000256 TYLNJ 04325537-45 10/29/1985 Letter to McNeil re: nomenclature of Tylenol® Elixir

D00000257 TYLNJ 04325534-35 11/12/1985 Letter to FDA re: Drug Recall D417-5

D00000258 TYLNJ 04273928 11/15/1985 Letter to FDA re: NDA 17-053 Interval Report No. 14


D00000259TYLNJ 04273925-26 11/18/1985

Letter to FDA re: NDA 17-053 Amendment to Interval Report No. 14

D00000260 TYLNJ 04325531 12/19/1985 Letter from FDA re: Recall D417-5

D00000261 12/23/1985 Letter to FDA regarding perodic report for ES Tylenol

D00000262TYLNJ 04325528 1/16/1986

Memo from C. E. Hammes re: FDA Notice Concerning Tylenol Elixir Product Exchange


D00000264TYLNJ 04273920 3/7/1986

Letter from FDA re: updated information on McNeil’s market withdrawal

D00000265 TYLNJ 03430268-69 3/17/1986 Correspondence from Val Brunell regarding hepatotoxicity in chronic alcoholics

D00000266 TYLNJ 04325527 3/18/1986 Letter to FDA re: NDA 9927

D00000267 TYLNJ 04325524-26 4/10/1986 Letter to FDA re: Recall D-417-5

D00000268 TYLNJ 04274325 6/3/1986 Memo from R. C. deGroof re: Hoechst Acetaminophen

D00000269 TYLNJ 04273915-16 6/10/1986 Letter to FDA re: status report on market withdrawal

D00000270 TYLNJ 04273912-13 7/25/1986 Waiver Request

D00000271 TYLNJ 04272869-71 7/25/1986 Waiver Request

D00000272 TYLNJ 04325514-15 8/18/1986 Letter from FDA re: Recall D-417-5

D00000273 TYLNJ 04325522 8/18/1986 Letter from FDA re: Recall D-417-5

D00000274 TYLNJ 03985200-02 8/20/1986 Tylenol Extra Strength Acetaminophen Tablets, NDA 17-552, Supplemental New Drug Application

D00000275 TYLNJ 04325516 8/20/1986 Letter to FDA re: Tylenol

D00000276 TYLNJ 04325517-18 8/20/1986 Letter to FDA re: Tylenol® Annual Report No. 15

D00000277 TYLNJ 04325519 8/20/1986 Letter to FDA re: Adverse Drug Experience Report

D00000278 TYLNJ 04325520 8/20/1986 Letter to FDA re: NDA 9927 D00000279 TYLNJ 04274322-23 8/20/1986 Letter to FDA re: NDA 17-552

D00000280 TYLNJ 04274324 8/20/1986 Letter to FDA, NDA 17-552

D00000281 TYLNJ 04274282-83 8/20/1986 Letter to FDA, NDA 17-552

D00000282 TYLNJ 03449364 8/20/1986 August 20, 1986 Letter from C. Hammes to FDA requesting waiver of submission of Form 1639 for adverse experiences

D00000283 TYLREP 00621960-61 8/22/1986 Letter from G Benson to L Seeff, cc to H Zimmerman, regarding literature.

D00000284 TYLNJ 01199014-9055 9/1/1986 McNeil Consumer Healthcare Clinical Study Report for Protocol 4-400: A Phase IV multicenter clinical investigation of the safety and efficacy of APAP 1000 mg (total daily dose of 4 grams), ibuprofen 400 mg (total daily dose of 1200 mg), and placebo in the management of the symptoms of primary dysmenorrhea. Fort Washington, PA: McNeil Consumer Healthcare, September 1986a (data on file).


D00000285 TYLNJ 06331394-451 9/1/1986 McNeil Consumer Healthcare Clinical Study Report for Protocol 3-277: A phase IV collaborative multi-clinic, double-blind study to compare efficacy of and side effects profile of acetaminophen and ibuprofen in the treatment of pain secondary to osteoarthritis. Fort Washington, PA: McNeil Consumer Healthcare, September 1986b (data on file).

D00000286TYLNJ 04325511-13 9/3/1986

Letter to U.S. Pharmacopeial Convention, Inc. re: Tylenol® Elixir

D00000287 TYLNJ 04274316 11/6/1986 Memo from C.E. Hammes D00000288 TYLNJ 04273912-13 11/6/1986 SNDA for Waiver of FD 1639S

D00000289 TYLNJ 04274311 12/15/1986 Memo from C.E. Hammes re: Hoechst Roussel DMF

D00000290 TYLNJ 04274306-07 4/6/1987 Letter from FDA re: CERT-12-11-87

D00000291 TYLNJ 04274305 4/20/1987 Memo from C.E. Hammes re: Tylenol Labeling

D00000292TYLNJ 04273901-02 4/23/1987

Letter to FDA re: final status report of voluntary market withdrawal



D00000295 TYLNJ 04325503-05 4/24/1987 Letter to FDA re: sNDA Changes Being Effected

D00000296 TYLNJ 04325499 4/27/1987 Letter from FDA re: NDA 9927/S-001

D00000297 TYLNJ 04325497-98 5/8/1987 Memo from R.C. deGroof re: USP Definition Elixir

D00000298TYLNJ 04273899 5/12/1987

Letter from FDA re: market withdrawal complete and effective



D00000301 7/1/1987 McNeil Consumer Healthcare Clinical Study Report for Protocol 84-462: A double-blind, single dose parallel study to compare analgesic efficacy and side effects profile of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, and placebo in the treatment of muscle contraction ('tension') headache. Fort Washington, PA: McNeil Consumer Healthcare, July 1987 (data on file).



D00000304TYLNJ 04325494 8/5/1987

Letter to FDA re: Tylenol Elixir Adverse Drug Experience Report

D00000305 TYLNJ 04325495-96 8/5/1987 Letter to FDA re: Tylenol Elixir Annual Report No. 16




D00000309 TYLNJ 03429897-99 11/9/1987 Memorandum from T. N. Gates regarding Background and Plan of Action for Alcohol and Acetaminophen FDA Inquiry

D00000310 DOMKE 035388-399 11/19/1987 Memorandum from T. N. Gates regarding recent publication in Norwegian Medical Journal

D00000311 TYLNJ 04274302 11/24/1987 Memo from P.J. Oliver re: NDA 17-552/S-020


D00000312 TYLNJ 04274270-72 12/1/1987 Letter from FDA re: NDA 17-552/S-020

D00000313 TYLNJ 03985247-48 12/1/1987 Correspondence from Robert Temple and Gerald Faich to Craig E. Hammes regarding FDA requirement waiver

D00000314 TYLNJ 04274282-83 12/7/1987 FDA Approval Letter, NDA 17-552/-020

D00000315 TYLNJ 04273563-67 12/7/1987 FDA Approval Letter, NDA 17-552/-020


D00000317 DOMKE 035409-410 12/14/1987 Memorandum from T. N. Gates regarding publications on hepatic toxicity with the therapeutic use of APAP both in alcoholic and non-alcoholic patients

D00000318 TYLNJ 04274256-58 1/8/1988 Letter to FDA re: NDA 17-552/S-020


D00000320 TYLNJ 04274249 3/14/1988 Memo from P. Oliver re: NDA 17-552



D00000323 TYLNJ 03396185 5/17/1988 McNeil submits NDA for Tylenol Extended Relief caplets

D00000324 TYLNJ 04325491 8/2/1988 Letter to FDA re: NDA 9927




D00000328 TYLNJ 04274240 8/22/1988 Letter to McNeil re: approved supplier

D00000329 TYLNJ 04274239 8/24/1988 Letter to McNeil re: NDA 17-552


D00000331 11/16/1988 53 Fed Reg 46204-260

D00000332 11/16/1988 53 Fed Reg 46214

D00000333 11/16/1988 TFM for the Internal Analgesic, Antipyretic, Antirheumatic Drug Products

D00000334 TYLNJ 04274230-31 3/9/1989 Memo from P.J. Oliver re: NDA Supplement #21



D00000337 TYLNJ 01247224-478 5/15/1989 Letter to FDA regarding Docket No. 77N-0094

D00000338 TYLNJ 04274324 5/15/1989 Letter to FDA regarding Docket No. 77N-0094

D00000339 TYLNJ 04274225-26; TYLNJ 04274316

6/8/1989Letter to FDA re: NDA 17-552/S-022

D00000340 TYLNJ 04274210-11 6/16/1989 Meeting Minutes of FDA/McNeil Meeting re: NDA 17-552

D00000341 TYLNJ 01247224-478 6/16/1989 Meeting Minutes of FDA/McNeil Meeting re: NDA 17-552

D00000342 TYLNJ 04274209; TYLNJ 04274225-26

6/20/1989Letter from FDA to McNeil re: NDA 17-552/S-022

D00000343 TYLNJ 04273885; TYLNJ 04273887;TYLNJ 04274209-11

6/27/1989

Letter from McNeil to FDA re: NDA 17-053

D00000344 TYLNJ 04325487-88 6/29/1989 NDA 9927 – Tylenol Annual Report No. 18

D00000345 TYLNJ 04325486 7/13/1989 NDA 9927 – Adverse Drug Experience Report

D00000346 TYLNJ 04273885 7/13/1989 NDA 9927 – Adverse Drug Experience Report

D00000347 TYLNJ 04274206;TYLNJ 04325487-88

8/2/1989NDA 17-552 – Letter from McNeil to FDA

D00000348 TYLNJ 04274205; TYLNJ 04325486

8/21/1989NDA 17-552 – Letter from McNeil to FDA


D00000349 TYLNJ 03416322-6436 00/00/1990 McNeil Clinical Study Report 88-856, A study comparing the efficacy and safety of acetaminophen sustained release 1300 mg to acetaminophen regular release 650 mg in the treatment of post-operative dental pain, 1990, (Data on file).

D00000350 TYLNJ 04274206 1/15/1990 FDA Submission to OTC Monograph from McNeil

D00000351 1/16/1990 Reply Comments to McNeil Submission to OTC Monograph


D00000353 TYLNJ 04274202 2/2/1990 Letter to FDA re NDA 17-552/S-023

D00000354 TYLNJ 04273882; TYLNJ 04274189-90

2/9/1990Letter from FDA re NDA 17-552/S-023

D00000355 TYLNJ 04325479-81 6/28/1990 Correspondence between Barron & Hambacher

D00000356 TYLNJ 04274202 6/28/1990 Correspondence between Barron & Hambacher

D00000357 TYLNJ 04274189-90 7/2/1990 FDA Amendment re: NDA 17-552

D00000358 TYLNJ 04325477-81 7/6/1990 Annual Report re: NDA 9927

D00000359 TYLNJ 04325476; TYLNJ 04274190

7/10/1990TYLENOL acetaminophen Elixir

D00000360 TYLNJ 04273881 7/16/1990 FDA submission re: NDA 9-927

D00000361 TYLNJ 04274187 7/16/1990 FDA Submission re: NDA 11-630

D00000362 TYLNJ 04273881; TYLNJ 04325477-78

7/20/1990 McNeil Letter to FDA re: NDA 17-053

D00000363 TYLNJ 04274187;TYLNJ 04325476

8/28/1990McNeil letter to FDA re: AER, NDA 17-552


D00000365 TYLNJ 04013026-04013031 9/14/1990 Letter from McNeil to FDA re CBE 19-872/S-024

D00000366 TYLNJ 04274183 9/17/1990 McNeil submission of Annual Report to FDA

D00000367 TYLNJ 04274182;TYLNJ 04274185

9/25/1990Letter from FDA re: McNeil's SNDA Application, NDA-17-552/S-024

D00000368 TYLNJ 02489388 2/11/1991 Memorandum from K. R. Maroy to A. R. Blanchard regarding Sandoz

D00000369 TYLNJ 02489255 3/15/1991 Sandoz Discussion Notes

D00000370 TYLNJ 06180091-0128 4/1/1991 McNeil Consumer Healthcare Clinical Study Report for Protocol 87-735: A double-blind, single dose, placebo-controlled, randomized study comparing the efficacy and safety of acetaminophen sustained release 1300 mg to regular release acetaminophen 1000 mg, naproxen 500 mg, and placebo in the treatment of postoperative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, April 1991a (data on file).

D00000371 TYLNJ 04274177-81; TYLNJ 04274183

7/31/1991McNeil submission to FDA re: NDA 17-552/S-023, Amendment #1

D00000372 TYLREP 00542544-577 7/31/1991 Correspondence from Chung Yang to Anthony Temple regarding research proposal.

D00000373 TYLNJ 04133662-675 8/1/1991 "Management of Acetaminophen Overdose" published by McNeil


D00000374 8/8/1991 Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventative Measures Recommendations of the Immunization Practices Advisory Committee

D00000375 TYLREP 00542542-543 8/16/1991 Memo from J Gaylor to T Gates re Dr. C.S. Yang.

D00000376 TYLNJ 04274172-73; TYLNJ 04274182

8/20/1991Letter to FDA regarding Executive Director of Regulatory Affairs position at McNeil

D00000377 TYLNJ 04274177-81; TYLNJ 04325472-75

9/10/1991Docket No. 91N-0350 with Enclosure

D00000378 TYLNJ 04274171-73 9/17/1991 McNeil adverse drug experiences report re: NDA 17-552

D00000379 TYLNJ 03393116-1499/23/1991

Correspondence from Chung Yang to Anthony Temple regarding research proposal

D00000380TYLNJ 04274170 9/27/1991

McNeil FDA Submission of Annual Report re: NDA 17-552

D00000381TYLNJ 04274168 11/14/1991

Contact with FDA re: Inspection of plant in Bishop, TX, NDA 17-552/S-023

D00000382 TYLREP00618826-2812/5/1991

Correspondence from Anthony Temple to Chung Yang regarding research proposal

D00000383 TYLNJ 04274167 12/19/1991 McNeil submission to FDA re: APAP analytical data

D00000384TYLNJ 04273867-4139 00/00/1992

Tylenol Extra Strength Capsules, NDA 17-053, Correspondence, Vol. 2 of 2

D00000385 TYLREP 00542519-529 1/22/1992 Correspondence from C. Yang to A Temple regarding revised research proposal.

D00000386TYLNJ 04274165 2/17/1992

McNeil submission to FDA re: Certificates of Analysis of tablets, NDA 17-522/S-022

D00000387 TYLNJ 02489372 2/19/1992 Memorandum from R. S. Levi to J. R. Chiesa regarding Sandoz Analgesic

D00000388 TYLNJ 02489253 2/24/1992 Memorandum from R. S. Levi to J. R. Chiesa regarding Sandoz Analgesic

D00000389 TYLREP 00541434 2/24/1992 Correspondence from T Gates to C Yang, regarding Grant.

D00000390TYLNJ 04274163-64 3/5/1992

McNeil letter to FDA re: Amendment to SNDA, NDA 17-522/S-022

D00000391 TYLNJ 02489252 4/16/1992 Email from Tony Vernon to Ralph Levi regarding Sandoz FS205-297 S. Lambert

D00000392 TYLNJ 02489331-332 4/23/1992 Memorandum from Tony Vernon to Susan Lambert regarding Sandoz

D00000393 TYLNJ 02489261 5/27/1992 Memorandum from R. T. Havard regarding Sandoz FS 205-397

D00000394 TYLNJ 03413493

6/4/1992

Correspondence from Vivian Chester to John G. Harter regarding Tylenol Extra Strength Tablets, NDA 17-552, Meeting Request

D00000395 TYLNJ 04274154 6/4/1992 McNeil meeting request with FDA re: NDA 17-552

D00000396TYLNJ 04274150 8/12/1992

FDA Compliance Officer letter to McNeil re: NDA 17-522 – 1992.8.12


D00000398 TYLNJ 04274148 8/19/1992 FDA Approval Letter re: NDA 17-522/S-022 & S-023


D00000399TYLNJ 04274147 10/2/1992

McNeil letter to FDA re: German Federal Health Dept, NDA 17-552

D00000400 TYLNJ 03396797-9910/12/1992

Correspondence from James Lenehan to Dr. David Pramer with Rutgers regarding letter of intent

D00000401 TYLNJ 04273870-71 11/5/1992 FDA withdrawal of approval, NDA 17-053

D00000402 TYLNJ 04273872 11/9/1992 FDA notice of withdrawal of approval, NDA 17-053

D00000403 TYLNJ 04273870-71 11/17/1992 FDA Nonprescription Drug Advisory Committee Meeting

D00000404 TYLREP00544621-623 11/18/1992 Correspondence from Patricia Stewart regarding meeting confirmation on Project Protect and proposed project plan

D00000405 TYLREP00544586-614 12/8/1992 Correspondence from Patricia Stewart regarding P. Gwilt paper

D00000406 TYLNJ 02489259 12/11/1992 Correspondence from Robert Havard to Dean Work regarding signed copy of Disclosure and Confidentiality Agreement

D00000407 TYLNJ 02489266 12/17/1992 Memorandum from R. T. Havard regarding Sandoz Second Generation APAP

D00000408 TYLNJ 04077078-04077079 12/18/1992 Record of Contact for December 18, 1992 meeting with FDA/Dr. John Harter regarding labeling of NDA 19-872 including "hepatic warning"

D00000409 TYLNJ 04273872 12/18/1992 FDA Pre-Approval Meeting Minutes re: SR APAP

D00000410TYLNJ 04274146 12/22/1992 McNeil submission of Annual Report to FDA, NDA 17-552

D00000411 TYLNJ 04274140-4485 00/00/1993 Tylenol Extra Strength Tablets, NDA 17-552, Correspondence

D00000412 TYLNJ 04077083-86 1/7/1993 Letter to FDA re: NDA 19-872

D00000413 TYLNJ 03413738-41 1/11/1993 Record of Contact

D00000414 TYLNJ 04274146 1/11/1993 Meeting Minutes re: McNeil/FDA meeting re: APAP SR caplets and APAP SR Pediatric Chewables

D00000415 TYLREP00544615-618 1/25/1993 Correspondence from Lena Ohannesian to Joanne Liebert and Barbara Smith regarding update on DAS Source

D00000416 TYLNJ 04274144 2/15/1993 McNeil submits adverse drug experiences, NDA 17-552


D00000418TYLNJ 02489268 3/26/1993

Memorandum from R. T. Havard to Dean Work regarding Sandoz meeting attendees

D00000419 TYLREP00544585 4/14/1993 Correspondence from Jean B. Eble to Barbara Smith regarding conference call to Parish Chemical

D00000420 TYLNJ 03742209-11 4/19/1993 Handwritten Notes

D00000421 TYLREP 00541179-180 4/19/1993 Correspondence from R Jones to Brugmans regarding Methionine-Acetaminophen.

D00000422 TYLREP 00540855-858 4/23/1993 Memo from E Piperno to P Stewart re Project Protect Cost Estimate.

D00000423 TYLNJ 02489236-37 4/27/1993 Memorandum from R. T. Havard regarding Sandoz

D00000424 TYLNJ 02489235 4/27/1993 Correspondence from Robert T. Havard to Dean Work regarding Sandoz


D00000425 TYLNJ 02489278 4/29/1993 Memorandum from R. T. Havard to R. B. Raffa regarding PRI

D00000426 TYLNJ 04274144 5/7/1993 Meeting minutes of meeting between McNeil and FDA, re: NDA 19-872

D00000427 TYLNJ 02489234 5/11/1993 Memorandum from R. T. Havard to J. Eble regarding Sandoz

D00000428 TYLNJ 04010879-80;TYLNJ 03943940-41

5/14/1993 Record of Contact

D00000429 TYLNJ 03478041 5/14/1993 Memo from Scott to R Levi re BTG/Penn Pharmaceuticals.

D00000430TYLREP00544546 5/20/1993 Memorandum from R. T. Havard regarding Rutgers/Sandoz

D00000431TYLNJ 02489295-96 6/1/993

Memorandum from R. B. Raffa to Robert T. Havard regarding Licensing Opportunity - Sandoz Analgesic

D00000432TYLNJ 02489298 6/3/1993

Memorandum from R. T. Havard to M. P. Letner regarding Sandoz

D00000433 TYLNJ 02489230 6/7/1993 Memorandum from R. T. Havard regarding Sandoz

D00000434 TYLNJ 04082648-68 6/16/1993 McNeil submissions to OTC Drugs Advisory Committee

D00000435 TYLNJ 02481989-2001 6/28-29/1993 FDA NDAC Meeting

D00000436 TYLNJ 03387118-19 7/2/1993 FDA request to McNeil for information from NDMA

D00000437 TYLNJ 03413992 8/10/1993 McNeil submission of position paper to FDA

D00000438TYLNJ 02489233 8/10/1993

Memorandum from Robert T. Havard to Dean Work regarding Sandoz

D00000439TYLNJ 03391560-63 8/20/1993

Correspondence from Vivian Chester to Michael Weintraub regarding Docket No. 77N-0094

D00000440 TYLNJ 03386724-27 8/30/1993 McNeil submission of proposed label warning to FDA

D00000441 TYLNJ 01226390-98 9/8/1993 FDA NDAC Advisory Committee Meeting

D00000442 TYLREP 00544527-532 9/14/1993 Piperno Memo re Safety (Project Protect)

D00000443 TYLREP 00541404-405 9/27/1993 Memo re PEITC and Flavonoids/APAP toxicity.

D00000444 TYLNJ 04274142 10/5/1993 Adverse Drug Experiences, NDA 17-552

D00000445 TYLREP 00541400 10/7/1993 Memo from R Havard regarding meeting with E Piperno, status of Project Protect.

D00000446TYLNJ 02489229 10/19/1993

Memorandum from R. T. Havard regarding Sandoz FS 205-397

D00000447

TYLNJ 03829462-69 11/9/1993Fact Sheet: Prevention and Amelioration of Acetaminophen Toxicity with Beta-Carotene, S. Baranowitz Patent 5,260,360

D00000448TYLNJ 04274813 12/23/1993 McNeil submission of Annual Report to FDA, NDA 17-552

D00000449 TYLREP 00583282-287TYLREP 00618508-511

6/17/1905 David Whitcomb, Presentation to McNeil Medical Department, TYLREP00583282-287January 1995 – Presentation, Project Protect Review, TYLREP00618508-511.

D00000450TYLNJ 04274486-4814 00/00/1994

Tylenol Extra Strength Tablets, NDA 17-552, Correspondence


D00000451 TYLNJ 04272190-53500/00/1994

Acetaminophen ER Caplet, 650mg, NDA 19-872 Chrono Book

D00000452 00/00/1994 Mylan 10-K filing

D00000453 TYLNJ 04274142 1/11/1994 FDA Approval of NDA 20-204

D00000454 TYLNJ 04272527 1/17/1994 McNeil submission to FDA of data tables, NDA 19-872

D00000455TYLNJ 04272520-21 1/26/1994

Minutes of Conference call between McNeil and FDA Pilot Drug Evaluation Staff

D00000456 TYLNJ 04272522-25 1/26/1994 Letter to FDA from McNeil, follow-up to conference call

D00000457 TYLREP 00542029 1/31/1994 Letter from R Levi to S Yamada re 1993 article on gomisin A relative to acetaminophen-induced hepatotoxicity.

D00000458 TYLREP 00541790-792 2/1/1994 Correspondence from R Levi to D Colella re agreement permitting examination of product.


D00000460TYLNJ 04272501-13 2/9/1994

McNeil submission to FDA of Final Printed Label, NDA 19-872

D00000461 TYLREP001315892/10/1994

Correspondence from Sadako Yamada to Ralph Levi regarding gomisin A

D00000462 TYLNJ 04272494-500 2/17/1994 McNeil request to FDA re: ibuprofen label language

D00000463 TYLREP 0541773 2/28/1994 Email from G Buehler to R Levi re Methionine Study.

D00000464 TYLNJ 04272501-13 3/1/1994 McNeil Organizational Chart

D00000465 TYLREP 00541770 3/11/1994 Correspondence from R Levi to D Collella regarding Methionine Acetaminophen tablets.

D00000466 TYLNJ 04272449-50 3/17/1994 McNeil submission of revised directions, MDA 19-872

D00000467

TYLREP00541768-69 3/25/1994

Correspondence from S. Flynn to R. Levi regarding BTG McNeil Agreement addressing evaluation of methionine acetaminophen tablets

D00000468 TYLNJ 03477529-304/5/1994

Correspondence from Ralph Levi to Edward Nelson regarding DDI patent

D00000469 TYLREP00540610-114/6/1994

Correspondence from R. Levi to S. Flynn regarding evaluation of methionine acetaminophen tablets

D00000470 TYLREP 00583240-244 4/12/1994 Temple Letter to Editor, JAMA.

D00000471 TYLNJ 03477503-044/19/1994

Correspondence from Sheila Flynn to Ralph Levi regarding methionine-containing tablets

D00000472 TYLNJ 02489423-25 4/21/1994 Memo to Piperno Advisory Group

D00000473 TYLREP 00583259-281 5/2/1994 Presentation, Medical Background OTC Analgesics and Alcohol.

D00000474TYLNJ 04272388-90 6/7/1994

FDA teleconference with McNeil re: label revisions, NDA 19-872

D00000475 TYLNJ 033951156/7/1994

Correspondence from Reyniers Geert to Ralph Levi regarding acetaminophen and methionine

D00000476 TYLNJ 04272386 6/7/1994 FDA teleconference with McNeil re: label revisions, NDA 19-872

D00000477 TYLNJ 03396561 6/7/1994 Correspondence from Ralph Levi to Reyniers Geert regarding APAP and Methionine

D00000478 TYLNJ 04272383-85 6/8/1994 McNeil letter to FDA re: label revisions, NDA 19-872



D00000480 TYLNJ 03938273-77 6/8/1994 FDA Letter to McNeil re: NDA 19-872

D00000481 TYLNJ 04123885-89 6/8/1994 FDA Approval of Tyl Extended Relief Caplet (650 mg)

D00000482 TYLNJ 04274791-93 6/15/1994 McNeil press release re: Tylenol ER

D00000483TYLNJ 04097155-57 6/16/1994

Correspondence from Vivian Chester and Paula Oliver to FDA regarding NDA 17-552 Special Supplement

D00000484TYLNJ 04009599-601 6/16/1994

McNeil submission of SNDA providing for label revisions, NDA 17-552/S-025

D00000485 TYLNJ 04274790-93 6/16/1994 McNeil forwards press release to FDA re: Tylenol ER

D00000486 TYLNJ 04097144-46 6/16/1994 McNeil letter to FDA’s Pilot Drug Evaluation re: revised warnings

D00000487 TYLNJ 04272371-74 6/16/1994 McNeil request for permission from FDA to add alcohol warning

D00000488 TYLNJ 04274804 6/16/1994 McNeil (Paula Oliver) sends FDA (Michael Weintraub) a letter advising of the label revisions submitted in 17-552/S-025.

D00000489 TYLNJ 04097138;TYLNJ 04274788

6/17/1994FDA acknowledgment of receipt of revisions to Tyl label, NDA 17-552/S-025

D00000490 6/20/1994 McNeil submission of SNDA to FDA re: child-resistant pouch, NDA 19-872/S-002


D00000492TYLNJ 04274787 6/22/1994

McNeil records of contact b/t McNeil and FDA Pilot Drug Evaluation Staff

D00000493TYLNJ 04274785 6/22/1994

FDA letter of advisement to McNeil re: proposed label revisions for E.S. Tyl, NDA 17-552/S-025

D00000494 TYLNJ 04272352 6/22/1994 FDA letter of advisement to McNeil re: proposed label revisions for E.S. Tyl, NDA 17-552/S-025

D00000495 TYLNJ 04097134 6/23/1994 Record of Contact regarding NDA 17-552/S-025

D00000496 TYLNJ 04097135 6/24/1994 Record of Contact










D00000506 TYLNJ 03740259-60 7/25/1994 Project Protect Recommendations



D00000509 TYLNJ 02484326-28 8/2/1994 Correspondence from T. E. Sox regarding Minutes of Project Protect Meeting on 7/28/94

D00000510 TYLREP 00544457-458 8/30/1994 T Sox memo regarding Project Protect, Methionine research and development.


D00000511 TYLNJ 03940317-03940359 9/1/1994 McNeil Consumer Healthcare Clinical Study Report for Protocol 93-322: A phase IV comparative study evaluating the onset of analgesia using a single dose of acetaminophen 1000 mg, naproxen sodium 440 mg, naproxen sodium 220 mg or placebo in post-operative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, September 1994a (data on file).

D00000512 TYLNJ 03941492-1535 9/1/1994 McNeil Consumer Healthcare Clinical Study Report for Protocol 93-321: A phase IV comparative study evaluating the onset of analgesia using a single dose of acetaminophen 1000 mg, naproxen sodium 440 mg, naproxen sodium 220 mg, or placebo in post-operative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, September 1994b (data on file).

D00000513 TYLNJ 03830729-730 9/22/1994 American Liver Foundation Fact Sheet – Ethical principles for corporate support from organizations with business interests in liver disease, approved 9/22/94.



D00000516TYLNJ 10586713-714 9/28/1994 Adult Acetaminophen-Containing Product Labeling (1994)



D00000519 TYLNJ 04272235-36 10/26/1994 Letter from FDA regarding NDA 19-0872/S-002

D00000520 TYLNJ 04272205-09 11/23/1994 Fax from FDA regarding NDA 17-552/S-025 & 19-872

D00000521 TYLNJ 04272210-12 11/23/1994 Letter to FDA regarding NDA 19-872/S-002

D00000522 TYLREP00892576-2577 12/1994 Taking Care of Your Cold or Flu


D00000524 TYLREP 00578502TYLREP 00578203

12/15/1994 Memo from E Nelson to P Stewart et al re homocysteine and methionine, TYLREP 00578502, with attachment – FDA Tan Sheet TYLREP00578203.

D00000525TYLREP00542206 12/16/1994

Correspondence from Thomas Sox to Robert Havard regarding APAP/methionine

D00000526 TYLREP00950826-0829 1/3/1995 McNeil Dr. Doctor Letter



D00000529 TYLNJ 06310724 - 06310738 1/12/1995 Letter to FDA regarding NDA 19-872

D00000530 TYLNJ 01169859-64 1/13/1995 Summary of Meeting Minutes


D00000532 TYLNJ 02475910-11 1/27/1995 Summary of Project Protect Meeting

D00000533 TYLREP00618450-503 1/27/1995 Elliott Piperno - Project Protect Update

D00000534

TYLNJ 04097093-97 1/27/1995

Correspondence from Vivian Chester to Robert Bedford, FDA, regarding Extra Strength Tylenol, NDA 19-872, Correspondence to NDA's - Response to Labeling Comments dated 11/23/94

D00000535 TYLNJ 04272788-93 1/27/1995 Fax to FDA regarding NDA 17-552/S-025, NDA 19-872

D00000536 TYLREP00544624-666 1/27/1995 Project Protect Update


D00000537 TYLREP00544667-701 2/3/1995 Study on Oral Antidotal Efficacy of D-Methionine vs L-Methionine vs DL-Methionine in Mice Acutely Overdosed with APAP

D00000538 TYLREP00544702-726 2/3/1995 Study on Pilot Oral Antidotal Efficacy of Beta-Carotene in Mice Acutely Overdosed with APAP

D00000539 TYLREP00544727-761 2/3/1995 Study on Oral Antidotal Efficacy of L-Methionine vs Diallyl Sulfone: A Repeat Study of HWA 2720-101

D00000540 TYLREP00544762-787 2/3/1995 Study on Oral Antidotal Efficacy of Succimer in Mice Acutely Overdosed with APAP

D00000541 TYLREP00544788-824 2/3/1995 Study on Oral Antidotal Efficacy of L-Methionine vs Diallyl Sulfone in Mice Acutely Overdosed with APAP

D00000542 TYLREP00544825-54 2/3/1995 Study on Acute Oral Toxicity Study in Mice with Acetaminophen

D00000543 TYLREP00545023-49 2/3/1995 Study on Oral Antidotal Efficacy of Beta-Carotene in Mice Acutely Overdosed with APAP

D00000544 TYLREP00545050-78 2/3/1995 Study on Acute Oral Antidotal Efficacy Study of Ascorbyl 6-Palmitate and of Alpha Tocopherol in APAP-Overdosed Mice

D00000545 TYLREP 00622800-801 2/6/1995 Correspondence from A Temple to A Brownsetin responding to inquiry re publicity, safety of acetaminophen.

D00000546 TYLREP00540882 2/21/1995 Memo from P. Stewart to LB Pickering regarding assessment of acetaminophen-combination products

D00000547 TYLNJ 03644343-58 3/00/1995 Brochure regarding Tylenol


D00000549 TYLREP00544855-78 3/2/1995 Establishment of a Dose of DAS02 and L-Methionine Sulfone in a Fixed Ration to Acetaminophen (1:20) Which Provides Protection Against Acetaminophen Overdose in Mice; PH 403-MCN-002-94

D00000550 TYLREP00544879-917 3/2/1995 To Determine the Relative Protective Ratio (DAS02 or L-Methionine Sulfone/Acetaminophen) in Mice Maintained on a 10% Ethanol Drinking Solution; PH 403-MCN-001-94

D00000551 TYLREP00544918-36 3/2/1995 Determination of DAS02 Relative Duration of Effect in Mice (Repeat of PH 403-MCN-005-93); PH 403-MCN-008-93

D00000552 TYLREP00544937-48 3/2/1995 Potential Protection of Acetaminophen-Induced Toxicity by DAS02 in Mice; PH 403-MCN-007-93

D00000553 TYLREP00544949-57 3/2/1995 Determination of the Potential Ability of Mice to Drink a 10% Ethanol in Water Solution (Pilot Study); PH 403-MCN-006-93

D00000554 TYLREP00544958-75 3/2/1995 Determination of DAS02 Relative Duration of Effect in Mice; PH 403-MCN-005-93

D00000555 TYLREP00544976-86 3/2/1995 The Effects of DAS02 on Acetaminophen-Induced Elevation of Alanine Aminotransferase (ALT) and Lactate Dehydrogenase (LDH) in Mice; PH 403-MCN-004-93


D00000556 TYLREP00544987-97 3/2/1995 Potential Protection of Acetaminophen at LD 30 by DAS02 in Mice; PH 403-MCN-003-93

D00000557 TYLREP00544998-5008 3/2/1995 Potential Protection of Acetaminophen at LD 30 by DAS02 in Mice; PH 403-MCN-002-93

D00000558 TYLREP00545009-22 3/2/1995 Determination of the LD 20 of Acetaminophen in Mice; PH 403-MCN-001-93

D00000559 TYLREP00545079-102 3/2/1995 Establishment of a Fixed Dose Ratio Which Provides Protection Against Acetaminophen Overdose in Mice with DAS02; PH 403-MCN-003-94

D00000560 TYLREP00545103-113 3/2/1995 The Effects of Acetaminophen Treatment Upon Alanine Aminotransferase (ALT) Determinations in Mice; PH 403-MCN-011-93

D00000561 TYLREP00545114-41 3/2/1995 Antidotal Efficacy of DAS02 in Mice Overdosed with a Range of Lethal Doses of Acetaminophen (1:20 Ratio); PH 403-MCN-010-93

D00000562 TYLREP00545142-53 3/2/1995 Single Dose Antilethal Effects of DAS02 Upon Acetaminophen Treated Mice; PH 403-MCN-009-93

D00000563 TYLNJ 02476169-71 3/3/1995 Memorandum from E. Nelson regarding Tylenol




D00000567 TYLREP00809090;TYLNJ 04272800

3/10/1995 Letter to FDA regarding NDA 19-872/S-004


D00000569 TYLNJ 03933293-94 3/17/1995 Letter to FDA regarding ANDA 74-652

D00000570 TYLNJ 04272795-96 3/19/1995 Letter from FDA regarding ANDA 74-652

D00000571 TYLREP 00623050-51 3/20/1995 Correspondences from A Brownstein to R Larson regarding scheduling meeting.

D00000572 TYLREP 00623019-22 3/21/1995 Fax from R Gussin to A Temple, re American Liver Foundation.A. Temple comments (undated) regarding April 13, 1995 Draft of ALF Policy Statement.


D00000574 TYLNJ 03830562 4/13/1995 Correspondence from A Brownstein to A Temple regarding American Liver Foundation Policy Statement, request to review and comment regarding same.

D00000575 TYLNJ 03830559 4/14/1995 Correspondence from A Temple to A Brownstein regarding request for review and comment on American Liver Foundation Policy Statement.

D00000576 TYLREP 00623014-22 4/18/1995 Correspondence from A Temple to A Brownstein following up on meeting of 4/17/95.


D00000577 TYLREP 00622942-3011 5/8/1995 Correspondence from A Temple to A Brownstein re risks of OTC pain relievers in alcoholic patients (TYLREP00622942) and attachments: (1) McNeil’s 8/9/93 Submission to the FDA NDAC on interaction between OTC NSAIDS/Aspiring and Alcohol (TYLREP00622943-3002); (2) B. Strom, Gastrointestinal bleeding associated with over the counter use of ibuprofen and aspirin, dated 3/23/93 (TYLREP006223003-011), TYLREP00622942-3011.

D00000578 TYLNJ 04272788-93 6/1/1995 Fax to FDA regarding NDA 19-872/S-006

D00000579 6/9/1995 Letter from FDA approving NDA 19-872/S-006

D00000580 TYLNJ 04272785 6/19/1995 Letter to FDA regarding ANDA 74-652


D00000582 TYLNJ 03830596-98 6/20/1995 Correspondence regarding Agenda for 6/21/95 meeting of American Liver Foundation and Johnson & Johnson,

D00000583 TYLNJ 03830702 6/21/1995 Meeting Agenda with American Liver Foundation


D00000585 TYLNJ 06310752-64 7/18/1995 Letter to FDA regarding NDA NDA 19-872






D00000591TYLNJ 02514407-4466 10/6/1995 Phase IV Commitment submission regarding NDA 19-872


D00000593 TYLNJ 04272736-38 10/23/1995 Letter to FDA regarding FDA-483





D00000598 TYLNJ 03809282-312 00/00/1996 Handbook of Experimental Pharmacology

D00000599 TYLNJ 04272631 1/5/1996 FDA Letter re: receipt of SNDA, NDA 19-872/S-007

D00000600TYLNJ 04272630; 1/10/1996

McNeil submission to FDA of Adverse Drug Report, NDA 19-872

D00000601 TYLNJ 03601001-06 1/30/1996 January 30, 1996 FDA Spontaneous Reporting System, Division of Epidemiology and Surveillance, Brief Description with Caveats of System

D00000602TYLNJ 04272617-18 2/9/1996

McNeil communication with FDA re: Final Field Alert, NDA 19-872

D00000603 TYLNJ 03939713-14 2/27/1996 Letter to FDA re: Advil Ads

D00000604 TYLNJ 03942717-03942718 3/1/1996 Letter to FDA re: AHP produced ads

D00000605TYLNJ 04274731 3/4/1996

McNeil meeting with FDA re: alcohol warning, NDA 17-552; NDA 19-872

D00000606 TYLNJ 04096722-233/6/1996

McNeil meeting with FDA re: alcohol warning, NDA 17-552; NDA 19-872


D00000607 3/7/1996 McNeil Dear Doctor Letter

D00000608 TYLNJ 03974222 3/8/1996 Press Release re: Alcohol Labeling



D00000611 3/14/1996 Letter to Nonprescription Drug Manufacturers Association

D00000612 3/24/1996 Letter from FDA to Aspirin Foundation of America

D00000613TYLNJ 06310791 - 802 4/17/1996

McNeil Adverse Drug Experience Report to FDA, NDA 19-872

D00000614 TYLNJ 04120241 4/26/1996 J&J Memo re: International APAP Labeling

D00000615TYLREP00809089 & 74 5/10/1996

FDA letter to McNeil re: changes in S-004, NDA 19-872/S-004

D00000616 TYLREP00809088 & 73 5/14/1996 McNeil communication with FDA re: S-004 labeling

D00000617 5/22/1996 Letter to FDA regarding NDA 17-552

D00000618 TYLNJ 03995665-66 5/24/1996 FDA Letter to Aspirin Foundation of America

D00000619TYLNJ 04272607 5/31/1996

McNeil letter to FDA re: SNDA label revisions, NDA 19-872, S-008

D00000620 TYLNJ 04272606 6/7/1996 FDA Letter re: receipt of label revisions

D00000621TYLNJ 04272600-02 6/12/1996 FDA approval letter re: 100 count bottle, NDA 19-872/S-007

D00000622 TYLNJ 06310803 - 13 7/8/1996 McNeil ADE Report, NDA 19-872

D000006238/19/1996

Center for Drug Evaluation and Research (CDER) Resolution of Disputes

D00000624 TYLNJ 04274710-11 8/30/1996 Letter to FDA regarding 17-552

D00000625 TYLNJ 04272583 9/3/1996 McNeil letter to FDA re: SNDA, NDA 19-872

D00000626 TYLREP00809087 9/18/1996 McNeil letter to FDA re: NDA 19-872

D00000627 TYLNJ 03568241-42 9/23/1996 FDA Letter to Aspirin Foundation of America

D00000628 TYLNJ 04274708 9/27/1996 McNeil ADE Report re: NDA 17-552

D00000629TYLNJ 04272556 10/1/1996 Meeting between McNeil and FDA, NDA 17-552 & 19-872


D00000631 TYLNJ 04274706 12/13/1996 McNeil Annual Report No. 25, NDA 17-552

D00000632 TYLNJ 04013432 12/18/1996 McNeil letter to FDA re: Mfr. Reports

D00000633 TYLNJ 04272554 12/26/1996 McNeil ADE Report, NDA 19-872

D00000634TYLNJ 10586715-717 1/0/1997

CALM (Partnered with the Association for the Care of Children's Health) (1997-Present)

D00000635 TYLNJ 04272553 1/2/1997 McNeil addendum to Annual Report 1

D00000636 TYLNJ 04274411; TYLNJ 04325594

1/17/1977McNeil Letter to Division of Poison Prevention for the Consumer Product Safety Commission

D00000637 TYLNJ 06009548-9623 3/1/1997 McNeil Consumer Healthcare Clinical Study Report for Protocol 93-318: A phase IV parallel, double-blind, randomized, single-dose study comparing the analgesic efficacy and safety of acetaminophen 1000 mg/day, naproxen sodium 440 mg/day, and placebo in the treatment of tension headache. Fort Washington, PA: McNeil Consumer Healthcare, March 1997 (data on file).


D00000638TYLNJ 04274684-86 3/31/1997 FDA letter to McNeil re: SNDA approval, NDA 17-552/S-024

D00000639 TYLNJ 04274681-82 3/31/1997 FDA letter re: receipt of SNDA, NDA 17-552/S-025

D00000640 TYLNJ 04272560-61 3/31/1997 FDA letter to McNeil re: SNDA, NDA 190872/S-008

D00000641 TYLNJ 06310836 - 845 4/4/1997 McNeil ADE Report re: NDA 19-872

D00000642 TYLNJ 04274683 4/9/1997 McNeil letter to FDA re: S-024, NDA 17-552/S-024

D00000643TYLNJ 04274680 4/9/1997

McNeil letter to FDA re: amendment of SNDA, NDA 17-552, S-025

D00000644TYLNJ 04272559 4/9/1997 McNeil letter to FDA re: intent to amend NDA 19-872/S-008


D00000646 4/23/1997 Letter from McNeil regarding Tylenol

D00000647

11/19/2010FDA - FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene

D00000648TYLNJ 04274660-73 5/19/1997 McNeil requests meeting with FDA re: Hoechst -Celanese

D00000649 TYLNJ 04272542-43 6/5/1997 McNeil letter to FDA re: Perrigo

D00000650 TYLNJ 04274657-59 6/16/1997 McNeil withdrawal of SNDA 17-552/S-024

D00000651 TYLNJ 04274657-59 6/17/1997 Letter to FDA regarding FDA 17-552/S-024

D00000652 TYLNJ 04272541 6/26/1997 FDA receipt of letter re: Perrigo


D00000654 TYLNJ 06310846 - 856 7/9/1997 McNeil ADE Report, NDA 19-872

D00000655 TYLNJ 04274652; TYLNJ 04272539

7/21/1997FDA letter to McNeil re: labeling, NDA 17-552/S-024; NDA 17-552/S-025

D00000656TYLNJ 04272558 7/21/1997

FDA letter to McNeil label evaluation, NDA 19-872/S-007; S-008

D00000657 TYLNJ 03563106-03563734 8/1/1997 McNeil Consumer Healthcare Clinical Study Report for Protocol 95-531: A phase IV comparative study evaluating the onset and total analgesia using a single dose of acetaminophen 1000 mg, ketoprofen 25 mg, ketoprofen 12.5 mg, or placebo in postoperative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, August 1997 (data on file).

D00000658 TYLNJ 03384948-949 8/3/1997 Memo from Madison to Gussin regarding Historical Review of Acetaminophen Antidote Development.

D00000659 TYLNJ 04120132 8/22/1997 Letter from S. M. Wood to Sheila Kelly


D00000661TLNJ 001171949-76 9/3/1997

FDA Memorandum re: Acetaminophen, Ibuprofen and Aspirin in Children

D00000662 TYLNJ 09217536 9/3/1997 FDA Memorandum re: Acetaminophen, Ibuprofen and Aspirin in Children




D00000665 9/18/1997 Nonprescription Drug Advisory Committee Meeting – Labeling and dosing of OTC Pediatric Analgesic/Antipyretic Drug Products Meeting Transcript

D00000666 TYLNJ 04274642 10/3/1997 McNeil letter to FDA re: pre-NDA meeting, NDA 17-552




D00000670 11/14/1997 62 Fed Reg 61041-61057

D00000671 TYLREP00816148-154 12/1/1997 Correspondence from A Brownstein to A Temple requesting review of ALF position statement on acetaminophen, Draft #16 dated 12/1/97.

D00000672 TYLNJ 04274633 12/10/1997 McNeil submits Annual Report 26 to FDA, NDA 17-552

D00000673 TYLNJ 10586718-719 12/11/1997 Infant's Tylenol Product Labeling (1997)

D00000674TYLNJ 04274613-32 12/18/1997 Pre-NDA meeting between McNeil and FDA, NDA 17-552

D00000675 TYLNJ 035447126-127 12/23/1997 Email from A Temple regarding conference call with American Liver Foundation executive director and medical director.

D00000676 TYLNJ 04272850-3082 1998-2000 Acetaminophen ER Caplet, 650mg, NDA 19-872 Chrono Book

D00000677 00/00/1998 Extra Strength Tylenol Gelcap Label

D00000678 TYLNJ 10586723-739 00/00/1998 BE SAFE (Partnered with APhA) (1998)

D00000679 TYLNJ 06617151-202 1/1/1998 RW Johnson Pharmaceutical Research Institute Clinical Study Report for Protocol TRAMAP-ANAG-002: Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002-AQ-22) in oral surgical pain. January 1998 (data on file).

D00000680 TYLNJ 04274611-12 1/16/1998 McNeil revised draft protocol of study, NDA 17-552

D00000681 TYLNJ 06617276-326 2/1/1998 RW Johnson Pharmaceutical Research Institute Clinical Study Report for Protocol TRAMAP-ANAG-003: Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002-AQ-22) in oral surgical pain. February 1998 (data on file).

D00000682 TYLNJ 04274610 2/18/1998 McNeil draft protocol submission to FDA, NDA 17-552

D00000683TYLNJ 04274604 3/5/1998

FDA letter to McNeil re: meeting minutes re: Pre-NDA meeting, NDA 17-552

D00000684 TYLNJ 04274594-98 3/26/1998 FDA letter to McNeil re: protocol 197-02, NDA 17-552

D00000685 TYLNJ 04274585-87 5/11/1998 McNeil requests to withdraw NDA 17-552

D00000686 TYLNJ 10586720-722 5/13/1998 Tylenol Brand Labeling - Extra Strength gelcaps (1998)

D00000687TYLNJ 04274553-54 5/15/1998 McNeil comments re FDA meeting minutes, NDA 17-552

D00000688 TYLNJ 04274549-05 5/19/1998 FDA receipt of McNeil request to withdraw NDA 17-552


D00000689 TYLNJ 06331452-1547 6/1/1998 McNeil Consumer Healthcare Clinical Study Report for Protocol 95-530: A comparative study using a single dose of acetaminophen, acetaminophen/tramadol hydrochloride, tramadol hydrochloride alone, and placebo in the treatment of postoperative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, June 1998 (data on file).

D00000690TYLNJ 04274528-46 6/8/1998

Internal McNeil memo re: Med watch form 3500A, NDA 17-552

D00000691TYLNJ 04273082 6/12/1998

McNeil submission of Annual Report No. 4 to FDA, NDA 17-552

D00000692TYLNJ 04274527 6/19/1998 McNeil fulfills FDA request for MedWatch forms, NDA 17-552

D00000693 TYLNJ 06330875-1393 7/1/1998 McNeil Consumer Healthcare Clinical Study Report for Protocol 96-534: A comparative study evaluating the analgesic efficacy of a single dose of acetaminophen 1000 mg, acetaminophen 1000 mg/dextromethorphan hydrobromide 30 mg, ibuprofen 400 mg, dextromethorphan hydrobromide 30 mg, or placebo in post-operative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, July 1998 (data on file).

D00000694 TYLNJ 06310857 - 869 7/16/1998 McNeil submits ADE Report to FDA, NDA 19-872

D00000695TYLNJ 04274518-19 8/24/1998 Teleconference between McNeil and FDA re: NDA 17-552

D00000696 TYLNJ 04149464 9/23/1998 McNeil submits Annual Report to FDA, NDA 17-552

D00000697TYLNJ 04273080 9/25/1998

McNeil submits 1997 Annual Report for Am. Assoc of Poison Control Ctrs to FDA, NDA 19-872

D00000698 10/1/1998 October 1998 Guidance for Industry, Advisory Committees: Implementing Section 120 of the FDA Modernization Act of 1997


D00000700 10/23/1998 63 Fed Reg 56789

D00000701 10/23/1998 63 Fed Reg 56801


D00000703

TYLNJ 10586740-773

11/1/1998Managing Osteoarthritis (OA)_ Diagnosis and Principles of Care (Partnered with American Medical Association) (1998)

D00000704 TYLNJ 04273074-76 11/2/1998 McNeil letter to FDA re: name change

D00000705TYLNJ 04273077-78 11/9/1998

FDA OTC Division & McNeil teleconference re: product name, NDA 19-872

D00000706TYLNJ 04274503 11/13/1998

FDA receipt of McNeil request to withdraw SNDA 17-552/S-024

D00000707TYLNJ 04273072-73 12/8/1998

McNeil submits SNDA for labeling and name revisions, NDA 19-872/S-009



D00000710 TYLREP 01020232-331 2/1/1999 Letter to FDA regarding Citizen Petition


D00000711 TYLNJ 10586787-835 2/1/1999 Citizen's Petition for Pediatric Tylenol (1999)

D00000712

TYLNJ 04273060-61 3/8/1999 Letter to FDA regarding NDA 19-872/S-006 Amendment 2D00000713 36 Fed Reg 18539D00000714 3/17/1999 64 Fed Reg 13066

D00000715 3/17/1999 64 Fed Reg 13254

D00000716 TYLNJ 04072583-85 6/21/1999 Letter to FDA regarding NDA 19-872D00000717 TYLNJ 06617019-78 7/1/1999 RW Johnson Pharmaceutical Research Institute Clinical

Study Report for Protocol TRAMAP-ANAG-012: Evaluation of the efficacy and safety of tramadol/APAP in oral surgical pain. July 1999a (data on file).

D00000718 TYLNJ 06617083-146 7/1/1999 RW Johnson Pharmaceutical Research Institute Clinical Study Report for Protocol TRAMAP-ANAG-010: Evaluation of the efficacy and safety of tramadol/APAP in oral surgical pain. July 1999 (data on file).

D00000719 TYLNJ 06617206-71 7/1/1999 RW Johnson Pharmaceutical Research Institute Clinical Study Report for Protocol TRAMAP-ANAG-013: Evaluation of the efficacy and safety of tramadol/APAP in oral surgical pain. July 1999c (data on file).

D00000720

TYLNJ 04273058-59 7/15/1999 Letter to FDA regarding NDA 19-873/S-009 Amendment 1D00000721 46 Fed Reg 24584

D00000722 TYLNJ 04274814 8/2/1999 Letter to FDA regarding NDA 17-552D00000723 TYLNJ 04274493 8/26/1999 Letter from FDA regarding recall D-208-8D00000724 TYLNJ 06310870-1025 9/2/1999 Letters to FDA regarding NDA 19-872D00000725 TYLNJ 04273053 9/3/1999 Letter to FDA regarding NDA 19-872/S-010D00000726 TYLNJ 04273050-52 9/9/1999 Letter from FDA regarding NDA 19-872/S-006D00000727 TYLNJ 04273049 9/15/1999 Letter to FDA regarding NDA 19-872/S-006D00000728 TYLNJ 04273042-45 9/15/1999 Letter from FDA regarding NDA 19-872/S-010D00000729

TYLNJ 04273040-41 10/1/1999 Letter to FDA regarding NDA 19-873/S-009 Amendment 2D00000730 TYLNJ 04273039 10/19/1999 Letter to FDA regarding NDA 19-872D00000731 00/00/2004 Tylenol PDR for NonPrescription DrugsD00000732

TYLNJ 10586774-786 11/16/1999Guidelines for the Management of Acetaminophen Overdose (1999)

D00000733 TYLNJ 04273027-31 11/19/1999 Letter to FDA regarding NDA 19-872/S-006D00000734

TYLNJ 04273017-18 12/22/1999 Letter to FDA regarding NDA 19-872/S-010 Amendment 1D00000735

TYLNJ 04273015 12/28/1999 Letter to FDA regarding NDA 19-872/S-009 Amendment 3D00000736 TYLNJ 04273011-14 1/6/2000 Letter from FDA regarding NDA 19-872/S-010D00000737 TYLNJ 04177259 1/7/2000 Letter to FDA regarding NDA 19-872D00000738 TYLNJ 04273006-09 1/10/2000 Letter to FDA regarding NDA 19-872/S-010D00000739 TYLNJ 04116449-50 1/11/2000 Letter from FDA regarding NDA 19-872/S-006D00000740 TYLNJ 04273005 1/14/2000 Letter to FDA regarding NDA 19-872D00000741 TYLNJ 04272995-3004; 146-155 1/21/2000 Letter to FDA regarding NDA 19-872D00000742 TYLNJ 04272992-93 4/4/2000 Letter to FDA regarding NDA 19-872/S-006 and S-010


D00000743 4/13/2000 Letter regarding April 27, 2000 meeting with the FDA

D00000744 TYLNJ 04272979 4/13/2000 Letter from FDA regarding NDA 19-872/S-009D00000745 TYLNJ 04272976-78 4/14/2000 Letter to FDA regarding NDA 19-872/S-009D00000746

TYLNJ 04272968-69 4/20/2000Memo from Paula Oliver to Kerry Rothschild regarding meeting with the FDA on April 27, 2000

D00000747

TYLNJ 04272966-67 4/24/2000Fax from Paula Oliver to Kerry Rothschild regarding Tylenol labeling

D00000748 TYLNJ 04272959-60 4/27/2000 Minutes of Meeting held April 27, 2000D00000749 TYLNJ 04272954-55 5/22/2000 Letter from FDA regarding NDA 19-872D00000750 TYLNJ 04227755-56 5/22/2000 Letter to FDA regarding NDA 17-552/S-020

D00000751

TYLNJ 04272952-53 6/1/2000 Letter to FDA regarding NDA 19-872/S-010 Amendment 2D00000752 TYLNJ 04174689-91 6/26/2000 Letter to FDA regarding NDA 19-872D00000753 TYLNJ 04178917 6/30/2000 Letter to FDA regarding NDA 19-872D00000754

TYLNJ 04272950-51 7/5/2000 Letter to FDA regarding NDA 19-872/S-009 Amendment 4D00000755 TYLNJ 04177388 7/13/2000 Letter to FDA regarding NDA 19-872D00000756 TYLNJ 04272941-43 7/13/2000 Fax from FDA regarding NDA 19-872/S-10D00000757

TYLNJ 04272935-40 7/14/2000 Letter to FDA regarding NDA 19-872/S-010 Amendment 3D00000758 TYLNJ 04272926-28 7/25/2000 Letter to FDA regarding NDA 19-872/S-010D00000759 TYLNJ 04194710-14;

TYLNJ 04272914-17

7/25/2000 Letter from FDA approving NDA 19-872/S-009

D00000760 TYLNJ 04194717-720; TYLNJ 04272918-19


D00000761 TYLNJ 04272912 8/8/2000 Letter to FDA regarding NDA 19-872D00000762 TYLNJ 09338776-96 8/8/2000 Letter to Charles J. Ganley Center for Drug Evaluation &

Research from McNeil re: Tylenol Arthritis Pain Caplet, 650 mg “FPL for Approved Supplement NDA 19-872/S-010”

D00000763 TYLNJ 06311026-274 8/14/2000 Letter to FDA regarding NDA 19-872D00000764 TYLNJ 04227753-54 8/14/2000 Letter regarding meeting with FDAD00000765 TYLNJ 09223439 8/31/2000 Letter to Charles J. Ganley Center for Drug Evaluation &

Research from McNeil re: Tylenol Arthritis Pain Caplet, 650 mg “FPL for Approved Supplement NDA 19-872/S-009”

D00000766 TYLNJ 09223212 9/7/2000 Letter to Charles Ganley – Center for Drug Evaluation and Research From McNeil re: Acetaminophen Extended Release Geltab, 650 mg – Complete Response to Approvable Letter Revised Labeling in Drug Facts Format

D00000767 TYLNJ 04272869-71 9/22/2000 Minutes of Teleconference, NDA 19-872

D00000768 TYLNJ 04272882-83 10/11/2000 Letter to FDA regarding NDA 19-872/S-011D00000769 TYLNJ 04272881 10/17/2000 Letter from FDA regarding NDA 19-872/S-011D00000770

TYLNJ 04272888 11/7/2000 Letter to FDA regarding NDA 19-872/S-006 Amendment 3D00000771 TYLNJ 04272866-68 11/20/2000 Minutes of Teleconference held November 20, 2000


D00000772 TYLNJ 04185986-6276 12/1/2000 McNeil Consumer Healthcare Clinical Study Report for Protocol 97-028: A single-dose, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of acetaminophen 1000 mg for the treatment of migraine headache pain. Fort Washington, PA: McNeil Consumer Healthcare, December 2000 (data on file).

D00000773 TYLNJ 01071090-01071243 12/1/2000 McNeil Consumer Healthcare Clinical Study Report for Protocol 98-069: A single-dose, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of acetaminophen 1000 mg for the treatment of migraine headache pain. Fort Washington, PA: McNeil Consumer Healthcare, December 2000 (data on file).

D00000774 TYLNJ 01076550-01076804 12/1/2000 McNeil Consumer Healthcare Clinical Study Report for Protocol 99-075: A randomized, double-blind, triple-dummy, placebo-controlled study evaluating the analgesic effect of using a single dose of acetaminophen 1000 mg, celecoxib 100 mg or ibuprofen 400 mg in postoperative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, December 2000 (data on file).

D00000775

TYLNJ 04272859-61 12/1/2000Memo from Paula Oliver regarding Citizen Petition from Aspirin Foundation of America

D00000776 TYLNJ 01207993-8270 12/20/2000 McNeil’s Response to Request for Acetaminophen Adverse Drug Experience Data, Follow-up to Correspondence dated May 22, 2000

D00000777 TYLNJ 01949196-203 12/20/2000 Correspondence from Paula J. Oliver to Charles Ganley regarding NDA 19-872 and Follow-up to Correspondence dated May 22, 2000

D00000778 TYLNJ 04272851-58 12/20/2000 Letter from FDA regarding NDA 19-872D00000779

TYLNJ 04273083-3340 0/0/2001Acetaminophen ER Caplet, 650mg, NDA 19-872 Chrono Book

D00000780 TYLNJ 04273338-40 1/11/2001 Letter from FDA approving NDA 19-872/S-006

D00000781 1/15/2001 CDER memo

D00000782 TYLNJ 04273322-33 1/19/2001 Letter to FDA regarding NDA 19-872D00000783

TYLNJ 04273320-21 1/25/2001 Letter to FDA regarding NDA 19-872/S-011 Amendment 1D00000784

TYLNJ 04273318-19 2/1/2001 Letter to FDA regarding NDA 19-872/S-011 Amendment 2D00000785 TYLNJ 04273316-17 2/12/2001 Letter from FDA approving NDA 19-872/S-011

D00000786 TYLNJ 04273313-14 2/21/2001 Letter from FDA regarding NDA 19-872/S-009D00000787 TYLNJ 04273311-12 3/6/2001 Letter from FDA regarding NDA 19-872/S-010D00000788 TYLNJ 04273304-09 3/13/2001 Letter to FDA regarding NDA 19-872D00000789

TYLREP 01027755-876 3/21/2001 Adult Acetaminophen Dosage Forms in Pediatric PatientsD00000790 4/00/2001 Organizational ChartD00000791 TYLNJ 04273286 5/21/2001 Letter to FDA regarding NDA 19-872


D00000792 TYLNJ 04273282-85 5/22/2001 Letter from FDA regarding NDA 19-872D00000793 TYLNJ 04273278-80 5/31/2001 Letter to FDA regarding NDA 19-872D00000794

TYLNJ 10586836-8376/1/2001 Asthma Awareness (Partnered with American Lung

Association (ALA)) (June 2001)

D00000795 TYLNJ 04273276-77 6/13/2001 Letter to FDA regarding NDA 19-872D00000796 TYLNJ 04273271-74 6/20/2001 Letter to FDA regarding NDA 19-872D00000797 TYLNJ 04273269-70 7/2/2001 Letter to FDA regarding NDA 19-872D00000798 TYLNJ 04273265-68 7/11/2001 Letter to FDA regarding NDA 19-872D00000799 TYLNJ 06311275-332;

TYLNJ 06311339-484 7/18/2001 Letter to FDA regarding NDA 19-872D00000800 TYLNJ 10586838-842 7/20/2001 Analgesic Scientific Council (July 2001)

D00000801 TYLNJ 04273263 8/15/2001 Letter to FDA regarding NDA 19-872D00000802 TYLNJ 04273262;

TYLNJ 06311333-338 8/21/2001 Letter to FDA regarding NDA 19-872 Annual Report No. 7D00000803 TYLNJ 04273245-52 9/6/2001 Letter to FDA regarding NDA 19-872D00000804

TYLNJ 02437352-982 9/18-20/2001McNeil Consumer Healthcare Experts Conference Drug Safety Monitoring , September 18-20, 2001

D00000805 TYLNJ 04273177-83 10/00/2001 McNeil "Know Your Medicine" brochureD00000806 TYLNJ 04273184-231 10/00/2001 Acetaminophen Critical AssessmentD00000807

TYLNJ 01072025-86

10/00/2001

Analgesic Use in the Adult Population of the United States: Acetaminophen, Aspirin, Ibuprofen and Naproxen; Results of a Population-Based Telephone Survey 1998-2001; Slone Epidemiology Unit, Boston University School of Public Health

D00000808

TYLNJ 04273239-40 10/5/2001 Fax from Paula Oliver regarding acetaminophen meetingD00000809 TYLNJ 04273237-38 10/8/2001 Letter to FDA regarding NDA 19-872D00000810 TYLNJ 04273233-34 10/10/2001 Fax to FDA regarding NDA 19-872D00000811 TYLNJ 10586843-847 10/12/2001 Analgesic Scientific Council (October 2001)

D00000812 TYL05-06 MM-12-8 0004-10 10/12/2001 FDA FOI Adult Data SetD00000813 TYLNJ 04273155-56 11/29/2001 Letter to FDA regarding NDA 19-872/S-012

D00000814TYLNJ 10586848-875 12/1/2001

Partners for Self-Care_ Supporting Self-Care for OA (Partnered with APhA) (December 2001)

D00000815 TYLNJ 04273090-149 12/17/2001 Letter to FDA regarding NDA 19-872D00000816 TYLNJ 04273087-89 12/20/2001 Letter to FDA regarding NDA 19-872D00000817 TYLNJ 04273084-86 12/21/2001 Letter to FDA regarding NDA 19-872D00000818

TYLNJ 05997268-7552 00/00/2002Acetaminophen ER Caplet, 650mg, NDA 19-872 Chrono Book

D00000819 TYLNJ 10586876-895 00/00/2002 Be MedWise (Partnered with NCPIE) (2002)

D00000820

TYLNJ 10586896-913 00/00/2002Appropriate Use of Common OTC Analgesics and Cough and Cold Medications (Partnered with AAFP) (2002)

D00000821

TYLNJ 10586914-915 00/00/2002Using OTC Pain Relievers in Combination with Prescription Medicines_ A Counseling Guide (Partnered with AAFP) (2002)

D00000822TYLNJ 10586916-917 00/00/2002

Know What's in the Medicines You Take (Partnered with AAFP) (2002)


D00000823

TYLNJ 10586918-937 00/00/2002OA_ Diagnosis and Management by Primary Care Clinicians (Partnered with the Family Practice Education Network) (2002)

D00000824TYLNJ 10586938-939 00/00/2002

How well do you know your medicine (Partnered with CRC) (2002)

D00000825

TYLNJ 10586942-943 00/00/2002Guidelines for the Prevention and Treatment of Influenza and the Common Cold (English & Spanish) (Partnered with ALA) (2002)

D00000826 TYLNJ 09365361-5393 00/00/2002 2002 Tylenol TV Ads

D00000827 1/9/2002 Meeting Minutes, January 9, 2002

D00000828 1/9/2002 Meeting Minutes, January 9, 2002

D00000829

TYLNJ 06979937-40 1/15/2002 Memo from CDER to FDA regarding OTC AcetaminophenD00000830 TYLNJ 05997502-04 1/16/2002 Letter to FDA regarding NDA 19-872D00000831 2/15/2002 Meeting Minutes, February 15, 2002D00000832 2/19/2002 Memo from S.R. Ahmad to C. Ganley. OPDRA Safety

Review; Review of Adult and Adolescents Exposure Data on Acetaminophen-containing products from two regional poison control centers – Utah and National Capital Area, PID#D010092. (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882b1_02_G-Acetaminophen%20Exposure%20Data.pdf)

D00000833 TYLNJ 05997439-40 2/21/2002 Fax from FDA regarding ISRsD00000834 TYLNJ 05997437 2/21/2002 Fax to FDA regarding NDA 19-872

D00000835 TYLNJ 05997408-23 2/22/2002 Meeting minutes

D00000836 TYLNJ 05997408-23 2/22/2002 PowerPoint Presentation


D00000838TYLNJ 10586944

3/00/2002 Prescription Acetaminophen Auxiliary Warning Labels (Partnered with First Data Bank) (March 2002)

D00000839

TYLNJ 10586945-962

3/00/2002Know Your Medicine (English & Spanish) (Partnered with CVS, Target, Walgreens and Wal-Mart) (March 2002)

D00000840

TYLNJ 10586963-968

3/00/2002 NACDS Chain Pharmacist Practice Memo_ Promoting the Safe Use of Analgesics (Partnered with NACDS) (March 2002)

D00000841 TYLNJ 01724830-34 4/00/2002 J&J Global Complaint Vigilance InitiativeD00000842

TYLNJ 10586940-941 4/4/2002Take Care When Taking Your Medicines (Partnered with CRC) (2002)

D00000843 TYLNJ 05541375-1406 4/15/2002 PowerPoint Presentation

D00000844 TYLNJ 01279858-861 4/23-24/2002 Meeting Agenda

D00000845 TYLNJ 01279862-71 4/23-24/2002 PowerPoint Presentation

D00000846 TYLNJ 05463409-18 4/23-24/2002 PowerPoint Presentation

D00000847 TYLREP01015555-56 4/23-24/2002 Data Form


D00000849 TYLNJ 00565465-66; TYNJ 00565398

5/23/2002 Letter to FDA regarding Tylenol




D00000852 TYLNJ 04251868-69 5/31/2002 Correspondence from Rich Cuprys to Charles Ganley regarding request for teleconference to discuss February 5, 2002 FDA Letter

D00000853 TYLNJ 10586969-976 6/8/2002 Analgesic Scientific Council (June 2002)

D00000854 TYLNJ 05997368-70 6/19/2002 McNeil letter to FDA re: Dr. Lee

D00000855TYLNJ 05997365 6/21/2002

McNeil confirms extension of time for Info Request Letter, NDA 19-872/S-012 & S-013

D00000856 TYLNJ 05997361 6/27/2002 McNeil email to FDA re: Info Request, NDA 19-872



D000008597/29-30/2002

McNeil Consumer & Specialty Pharmaceuticals (2nd) Case Assessment Conference



D00000862

TYLNJ 06311485-6758/1/2002

McNeil submission of Annual Report for Tyl Arthritis Pain, NDA 19-872

D00000863 TYLNJ 01236877-6901 8/2/2002 Memo from C Karkwoski to C Ganley. Briefing Document, Acetaminophen-Containing Products, Hepatotoxicity. Summary of FDA FOI Data SET – 25 Pediatric cases, 282 Adult cases. (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882b1.htm, last visited 5/20/2014)

D00000864 8/2/2002 Memo from R Neuner to L Katz. Literature research submitted in preparation for the September 2002 Advisory Committee Meeting on over-the-counter (OTC) analgesic safety issues. (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882b1.htm, last visited 5/20/2014)

D00000865 8/15/2002 Memo from P. Nourjah to C Ganley. Epidemiology of acetaminophen-related overdose, Hepatotoxicity, PID#D010092. (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882b1.htm, last visited 5/20/2014)

D00000866 TYLNJ 05997351 8/16/2002 McNeil letter to FDA re: info for Phase IV studies

D00000867

TYLNJ 10586979-7006 9/1/2002Partners in Self-Care_ Drug Interactions Involving Commonly Used Nonprescription Medications (Partnered with APhA) (September 2002)

D00000868 TYLNJ 04230896-1061 9/1/2002 September 2002 McNeil Meeting Materials

D00000869TYLNJ 10586977-978 9/12/2002 McNeil Dear Pharmacist Correspondence (September 2002)

D00000870 TYLNJ 00481356-1357 9/12/2002 McNeil Dr. Doctor Letter

D00000871 TYLNJ 05054909-4910 9/12/2002 McNeil Dr. Pharmacist Letter


D00000872

9/19/2002

FDA Ad Comm Meeting Briefing Information (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882b1.htm, last visited 5/20/2014)

D00000873 TYLNJ 01524412-82 9/19/2002 Assessment of Acetaminophen Safety and Efficacy

D00000874TYLNJ 04245400-12 9/19/2002 Dart Presentation CDER/NDAC - Acetaminophen Safety

D00000875

TYLNJ 01524217-371 9/19/2002McNeil Consumer & Specialty Pharmaceuticals September 19, 2002 NDAC meeting background package

D00000876TYLNJ 04230896-31061 9/19/2002

OPEN APAP Background Package Meeting McNeil Consumer & Specialty Pharmaceuticals

D00000877 TYLREP01067818-8538 9/19/2002 FDA Meeting Transcript

D00000878 9/19/2002 FDA - Points for Discussion - Nonprescription Drugs Advisory Committee http://www.fda.gov/ohrms/dockets/ac/02/questions/3882Q1_Discussion%20Points%20Fin...

D00000879 09/19-20/2002 September 19-20, 2002 Advisory Committee Meeting Transcript

D00000880

TYLNJ 01524372-411 9/20/2002McNeil Consumer & Specialty Pharmaceuticals September 20, 2002 NDAC meeting background package

D00000881

9/20/2002McNeil requests dosing instruction on the label for children under 2 yr. FDA does not take action on this request

D00000882 TYLNJ 10587007-008 10/1/2002 Tylenol Labeling Changes (October 2002)

D00000883 TYLNJ 05997371-72 10/15/2002 Letter to FDA regarding NDA 19-872/S-012 D00000884 TYLNJ 05997347-48 10/15/2002 Letter to FDA regarding NDA 19-872/S-013


D00000886 TYLNJ 09338799-808 10/16/2002 Letter to Charles J. Ganley Center for Drug Evaluation & Research from McNeil re: Tylenol Arthritis Pain Extended Relief Caplet, 650 mg NDA 19-872 Amendment to S-012

D00000887

TYLNJ 05997320-34 10/24/2002McNeil sends FDA correspondence re: film coating system for Tyl Arthritis Pain Extended Relief Caplets, NDA 19-872

D00000888

TYLNJ 10587037-045 11/0/2002OTC Analgesics and Alcohol Consumption (Partnered with Case Western Reserve University) (November 2002)

D00000889TYLNJ 05997315-17 11/1/2002 FDA releases McNeil from Phase IV studies, NDA 19-872

D00000890 TYLNJ 01232551 11/12/2002 Letter to FDA NDA 19-872



D00000893TYLNJ 05997330-33 11/26/2002

Letter from Paula Oliver to Charles Ganley regarding NDA 19-872


D00000894

TYLNJ 10587046-073 12/1/2002Partners in Self-Care_ Achieving Optimal Therapeutic Outcomes with Nonprescription Analgesics (Partnered with APhA) (December 2002)


D00000896 TYLNJ 05997299 12/4/2002 Letter to FDA regarding NDA 19-872/S-014,



D00000899 TYLNJ 09338832-40 12/4/2002 Letter to Charles J. Ganley Center for Drug Evaluation & Research from McNeil re: Acetaminophen Extended Release Geltab, 650 mg NDA 19-872 Amendment #1 to SNDA S-014 (CBE dated 11/26/2002)


D0000090112/23/2002

Obtaining Follow-up Information on Spontaneous Adverse Drug Experience(s) and Health Experience(s)



D00000904 TYLNJ 10587087-088 00/00/2003 Compare Your Medicines (Partnered with AAFP) (2003)

D00000905TYLNJ 10587089-093

00/00/2003 Know What's In Your Medicines (Partnered with AAFP) (2003)






D00000911

TYLNJ 10587109-112 2/14/2003Evaluating the Comparative Risks of OTC Medications (Partnered with the University of Colorado School of Medicine) (February 2003)


D00000913 TYLNJ 10587113-124 3/13/2003 Analgesic Scientific Council Meeting (March 2003)



D00000916

TYLNJ 04265486-89 3/21/2003McNeil documents FDA’s responses to the questions presented at the January 28, 2003 meeting, NDA 19-872

D00000917TYLNJ 04265484-85 3/28/2003

McNeil submits SNDA providing for a change in film coat & logo to Tylenol 8 Hour.

D00000918

TYLNJ 10587125-145 3/31/2003Partners in Self-Care_ The Pharmacists Role in Assuring Appropriate OTC Medication Use (Partnered with APhA) (March 2003)

D00000919TYLNJ 04265481-82 4/9/2003

FDA acknowledges McNeil’s withdrawal of the SNDA, NDA 19-872/S-015

D00000920 TYLNJ 05380474 4/14/2003 Tylenol Extra Strength Print AdTYLEPM-0033

D00000921 TYLNJ 06038526-534 5/2/2003 Memorandum from P. Childress regarding assessment of collection process for Adverse Events & Product Complaints


D00000922 TYLNJ 05380475 5/6/2003 Tylenol Extra Strength Coupon Print AdTYLEPM-0034

D00000923 TYLNJ 01213801-03 5/8/2003 Letter to the FDA regarding NDA 19-872

D00000924 TYLNJ 05380486 5/14/2003 Tylenol 8 Hour Print AdTYLEPM-0052

D00000925 TYLNJ 04265471-73 5/22/2003 Letter to the FDA regarding NDA 19-872

D00000926 TYLNJ 09338823-31 5/22/2003 Letter to Charles J. Ganley Center for Drug Evaluation & Research from McNeil re: Tylenol 8 Hour acetaminophen extended release geltab and Caplet, 650 mg NDA 19-872 – Amendment to SNDA S-014


D00000928 TYLNJ 00691058-64 5/28/2003 Letter from FDA

D00000929 TYLREP01069401-02TYLNJ 00691065-69

5/28/2003FDA approves SNDA to change Drug Facts re: NDA 19-872/S-013

D00000930 TYLNJ 04265460-64 5/28/2003 Letter from FDA approving 19-872/S-013 D00000931 TYLNJ 04265453-59 5/28/2003 Letter from FDA approving NDA 19-872/S-014 D00000932 TYLREP01829558-59;

TYLNJ 00691071-75;TYLNJ 04265436-40


D00000933 LM005871-78 5/29/2003 Standard Operating Procedure

D00000934 TYLNJ 10587094-108 6/0/2003 Your Child's Health (2003)

D00000935

TYLNJ 10587146-148 6/0/2003Partners in Self-Care_ The Pharmacist's Role in Assuring Appropriate OTC Medication Use (Partnered with APhA) (June 2003-Present)

D00000936 TYLNJ 00691071-75 6/4/2003 Letter from FDA

D00000937TYLNJ 10587149-166 6/19-22/2003 APhA Self-Care Institute (Partnered with APhA) (June 2003)


D00000939TYLNJ 10587167-170 7/0/2003

Tylenol Infant's Concentrated Drops Labeling Additions (July 2003)

D00000940TYLNJ 04265427 7/10/2003 McNeil submits labeling for Tyl 8 Hour, NDA 19-872/S-016


D00000942TYLNJ 04265420 8/1/2003 McNeil submits annual ADE Report to FDA, NDA 19-872

D00000943 TYLNJ 04265422-24 8/1/2003 Letter from FDA approving NDA 19-872/S-016D00000944 TYLNJ 05380487 8/1/2003 Tylenol 8 Hour Print Ad

TYLEPM-0056

D00000945 TYLNJ 05380488 8/1/2003 Tylenol 8 Hour Marathon First Timers Print AdTYLEPM-0057

D00000946 TYLNJ 04265419; TYLNJ 06311676 -923

8/7/2003 McNeil submits 9th Annual Report to FDA, NDA 19-872

D00000947 9/22/2003 Standard Operating Procedure


D00000948 9/22/2003 Standard Operating Procedure

D00000949TYLNJ 04265418 9/22/2003

McNeil submits SNDA for Tyl 8 Hour Geltabs, NDA 19-872/S-017

D00000950TYLNJ 04265417 9/24/2003

McNeil submits addendum to 9th Annual Report to FDA, NDA 19-872

D00000951 TYLNJ 10587171-208 10/7/2003 Analgesic Scientific Council (October 2003)

D00000952 TYLNJ 10587209 10/8/2003 McNeil Hepatology Seminar (October 2003)

D00000953 TYLNJ 04265416 10/13/2003 McNeil submits SNDA to FDA, NDA 19-872/S-018

D00000954TYLNJ 04265412-15 10/23/2003

FDA acknowledges receipt of McNeil’s proposed SNDA providing for Tylenol 8 Hour Geltabs, NDA 19-872/S-017

D00000955 TYLREP01826980-86;TYLNJ 04265411

10/28/2003McNeil confirms to FDA its commitment to use correct labeling

D00000956TYLNJ 04265408-10 10/31/2003

McNeil submission of SNDA re manufacturing process, NDA 19-872/S-019

D00000957

TYLNJ 10587210-211 11/8/2003Choosing the Right Analgesic for Your Patients (Partnered with the University of Colorado School of Medicine) (November 2003)

D00000958TYLNJ 04265406 11/19/2003

Amendment to SNDA re: alternate trade name of Tyl 8 Hour, NDA 19-872/S-018

D00000959

TYLNJ 10587212-238 12/00/2003Partners in Self-Care_ Assisting Self-Treating Patients Quickly and Effectively (Partnered with APhA) (December 2003)

D00000960 TYLNJ 05380462 12/8/2003 Tylenol A Better Choice Print AdTYLEPM-0001

D00000961 TYLREP01827955-963; TYLNJ 04265407

12/18/2003NDA 19-872 FPL for approved S-016

D00000962 TYLNJ 09338853-59 12/18/2003 Letter to Charles J. Ganley Center for Drug Evaluation & Research from McNeil re: Tylenol 8 Hour Caplets (650 mg acetaminophen extended release tablets) “FLP for approved supplement NDA 19-872/S-016”

D00000963TYLNJ 04265393-405 12/19/2003

McNeil submits SNDA re manufacturing site for Tylenol extended release caplets, NDA 19-872

D00000964TYLNJ 06128335-62 00/00/2004

Patterns of Medication Use in the United States, A Report from the Slone Survey

D00000965TYLNJ 10587249-250 00/00/2004

Infants' and Children's Tylenol_ Professional Dosing Information (2004)

D00000966TYLNJ 10587251-252 00/00/2004 Infants' and Children's Tylenol_ Dosing Information (2004)

D00000967

00/00/2004 US Food and Drug Administration. (2004). Challenge and Opportunity on the Critical Path to New Medical Products.


D00000969 TYLNJ 10587239-248 1/0/2004 Stop.Think.Tylenol (2004-Present)

D00000970 TYLNJ 10587503-504 1/0/2004 Tylenol.com-How to read a Drug Label (2004-Present)

D00000971TYLNJ 10587505-507

1/0/2004 Tylenol.com_ Essential Tips for Parents & How to Give Medication Correctly (2004-Present)


D00000972 TYLNJ 10587508-509 1/0/2004 Tylenol.com_ Children's Dosage Guide (2004-Present)

D00000973 TYLNJ 10587510-513 1/0/2004 Tylenol.com_ View Top Pain Relievers (2004-Present)

D00000974 TYLNJ 10587514-523 1/0/2004 Tylenol.com_ Test Your Knowledge (2004-Present)

D00000975 TYLNJ 04265385-87 1/2/2004 FDA confirms Teleconference with McNeil, NDA 19-872


D00000977 TYLREP01829502; TYLNJ 04265383

1/13/2004 McNeil submits Final Product Label, NDA 19-872, S-013

D00000978 TYLREP01829503; TYLNJ 04265384

1/13/2004McNeil submits amendment to SNDA re: Tyl 8 Hour containers, NDA 19-872/S-017

D00000979 TYLNJ 09338809-17 1/13/2004 Letter to Charles J. Ganley Center for Drug Evaluation & Research from McNeil re: Tylenol 8 Hour Geltabs (650mg acetaminophen extended release geltabs) “FPL for Approved Supplement NDA 19-872/S-013”

D00000980 TYLREP01189245 1/16/2004 McNeil correspondence re: labeling, publicity, etc

D00000981 1/22/2004 FDA Consumer Campaign on Safe Use of OTC Pain Products

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108228.htm

D00000982 TYLNJ 00589197-228 2/1/2004 McNeil Consumer Healthcare Clinical Study Report for Protocol 02-156: A single-dose, double-blind, placebo-controlled study of the relative efficacy and safety of acetaminophen at doses of 500 mg and 1000 mg in postoperative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, February 2004a (data on file).

D00000983 TYLNJ 01515896-6766 2/1/2004 McNeil Consumer Healthcare Clinical Study Report for Protocol 99-090: A four-week comparative study evaluating acetaminophen extended release (3900 mg/day) and rofecoxib (12.5 mg/day and 25 mg/day) in the treatment of osteoarthritis of the knee. Fort Washington, PA: McNeil Consumer Healthcare, February 2004 (data on file).

D00000984 TYLNJ 05380463 2/1/2004 Tylenol Arthritis Pain Extended Relief Print AdTYLEPM-0002

D00000985TYLNJ 04265374-75 2/9/2004

McNeil submits generic labels for generic 8 Hour APAP products to the FDA

D00000986TYLREP01827974-982 2/10/2004

McNeil submits Final Product Labels for Tylenol 8 Hour caplets, NDA 19-872/S-016.

D00000987 TYLNJ 09338841-45 2/10/2004 Letter to Charles J. Ganley Center for Drug Evaluation & Research from McNeil re: Tylenol 8 Hour Caplets “FPL For Approved Supplement NDA 19-872/S-016”


D00000989

TYLNJ 10587304-331 3/00/2004Partners in Self-Care_ Challenging Issues in Self-treating Patients (Partnered with APhA) (March 2004-Present)


D00000990TYLNJ 10587363-366 3/00/2004

Highlights Newsletter_ Self- Treatment Options for Insomnia (Partnered with APhA) (March 2004)

D00000991 3/1/2004 FDA Inspection Report

D00000992 TYLNJ 05380478 3/8/2004 Tylenol Extra Strength Tuition Relief Print AdTYLEPM-0040

D00000993 TYLNJ 04265379-81 3/15/2004 McNeil submits info for SNDA, NDA 19-872/S-017

D00000994 TYLREP01827990-97; TYLNJ 04265355

3/18/2004McNeil submits Final Printed labeling for SNDA 19-872/S-018

D00000995 TYLNJ 09338860-72 3/18/2004 Letter to Charles J. Ganley Center for Drug Evaluation & Research from McNeil re: Tylenol (acetaminophen Arthritis Pain Geltab, 650 mg NDA 19-872 Final Printed Labeling SNDA S-018 CBE-30 (submitted 10/13/2003)



D00000998TYLNJ 10587253-281 3/27/2004

Partners in Self Care_ The Management of OA (Partnered with APhA) (March 2004)

D00000999

TYLNJ 10587282-303 3/28/2004Partners in Self-Care_ Drug Interactions_ Issues with Common OTC Medications (Partnered with APhA) (March 2004)

D00001000 4/1/2004 FDA Guidance for Industry – Changes to an approved NDA or ANDA


D00001002TYLNJ 04265350-51 4/5/2004

McNeil submits SNDA for change in testing, NDA 19-872/S-020


D00001004 TYLNJ 05380467 4/19/2004 Tylenol Arthritis Pain Extended Relief Print AdTYLEPM-0006


D00001006

TYLNJ 10587367-368 5/00/2004The One Minute Counselor-The Role of Nonprescription Analgesics in the Treatment of OA (Partnered with APhA) (May 2004)


D00001008

TYLNJ01178583-661

5/18/2004Correspondence from Nancy L. Buc to FDA regarding Request for Reconsideration of Complaint and Request for Correction to Federal Data Quality Act Concerning “Consumer Campaign on Safe Use of OTC Pain Products”

D00001009TYLNJ 10587369-380 6/0/2004 APhA Self Care Institute (Partnered with APhA) (June 2004)


D00001011TYLNJ 04265331-33 7/13/2004

McNeil requests extension to Annual ADE Report due date, NDA 19-872

D00001012TYLNJ 04265326-27 7/22/2004 FDA grants McNeil extension re: ADE Reports, NDA 19-872


D00001013

TYLNJ 10587381-382 8/0/2004The One Minute Counselor-A Pharmacistâ€™s Guide to Treating Acute Sports Injuries (Partnered with APhA) (August 2004)

D00001014 TYLNJ 01009078-568 8/1/2004 McNeil Consumer Healthcare Clinical Study Report for Protocol 11-303: A randomized, double-blind, placebo-controlled study evaluating acetaminophen extended-release caplets (3900 mg/day) in the treatment of post-race muscle aching and pain (soreness). Fort Washington, PA: McNeil Consumer Healthcare, August 2004b (data on file).

D00001015 TYLNJ 01010957-01011180 8/1/2004 McNeil Consumer Healthcare Clinical Study Report for Protocol 11-202: A randomized, double-blind, double-dummy, placebo-controlled, parallel group study of acetaminophen 1000 mg and ibuprofen 400 mg in postoperative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, August 2004a (data on file).

D00001016 TYLNJ 01007966-8184 8/1/2004 McNeil Consumer Healthcare Clinical Study Report for Protocol 11-201: A randomized, double-blind, double-dummy, placebo-controlled, parallel group study of acetaminophen 1000 mg and ibuprofen 400 mg in postoperative dental pain. Fort Washington, PA: McNeil Consumer Healthcare, August 2004b (data on file).


D00001018 TYLNJ 04265328; TYLNJ 06311924- 014

8/6/2004 McNeil submits Annual Report 10 to FDA, NDA 19-872

D00001019 TYLREP01828585-627; TYLNJ 04265321-24

8/6/2004 McNeil submits amendment to SNDA, NDA 190872/S-021

D00001020 TYLNJ 09338873-80 8/6/2004 Letter to Charles J. Ganley Center for Drug Evaluation & Research from McNeil re: NDA 19-872/S-021 Acetaminophen Extended Release Caplet and Geltab, 650 mg Amendment to Supplement 021 and Final Printed Label (FPL)


D00001022 TYLNJ 05380519 8/19/2004 Tylenol Stop.Think. Print AdTYLEPM-0240

D00001023 TYLNJ 01178663-671 8/25/2004 Letter from Steven Galson to McNeil

D00001024

TYLNJ 10587383-409 9/0/2004Partners in Self-Care_ Self- Treatment Options for Common Sports and Physical Activity Injuries (Partnered with APhA) (September 2004-Present)


D00001026 TYLNJ 05380527 9/14/2004 Children's Tylenol Coupon Print AdTYLEPM-0255

D00001027TYLNJ 04265309 9/16/2004

McNeil amends SNDA providing for package change to Tyl Arth, NDA 19-872/S-021


D00001028

TYLNJ 01156432 9/30/2004Tylenol Public Relations Historical Perspective—Historical Overview: 1982-2004 Media/Consumer Analysis, SWOT Analysis.

D00001029TYLNJ 10587412-431 10/0/2004

Know Your Medicine, Know Your Pharmacist (Partnered with APhA) (October 2004-Present)

D00001030TYLNJ 10587410-411 10/0/2004

The One Minute Counselor- Avoiding Drug Interactions with Analgesics (Partnered with APhA) (October 2004)

D00001031 TYLNJ 05380523 10/1/2004 Tylenol Infants Stop.Think. Print AdTYLEPM-0245

D00001032 TYLNJ 05380526 10/4/2004 Tylenol Stop.Think. Print AdTYLEPM-0253

D00001033 TYLNJ 05380528 10/8/2004 Tylenol Arthritis Pain Print AdTYLEPM-0256

D00001034

TYLNJ 01178570-81

10/22/2004

Request for Reconsideration of Complaint and Request for Correction to Federal Data Quality Act Concerning “Consumer Campaign on Safe Use of OTC Pain Products”


D00001036 10/29/2004 Letter to FDA OTC Extra Strength Caplets, Drug Product Listing

D00001037 TYLNJ 05380531-0538 11/1/2004 Children's Tylenol Print AdTYLEPM-0261

D00001038 TYLNJ 04265301-03;TYLNJ 00691790-975;TYLNJ 00691701-708;

11/3/2004

Letter from FDA approving NDA 19-872/S-021D00001039

TYLNJ 04265300 11/5/2004McNeil submits annual Adverse Drug Experience Report for Tylenol Arthritis Pain extended relief caplets, NDA 19-872.

D00001040 TYLNJ 09297542 11/8/2004 Tylenol Advertisement entitled "Read the Label" TYLEPM-0268

D00001041 TYLNJ 00503783 11/11/2004 Letter to FDA regarding NDA 19-872D00001042 TYLNJ 09365478-5501 00/00/2005 2005 Tylenol TV Ads

D00001043TYLNJ 02523119-40

00/00/2005 Patterns of Medication Use in the United States, A Report from the Slone Survey

D00001044

TYLNJ 10587524-529

00/00/2005 Clinician's Guide_ Safety and Efficacy Concerns in Mild-to- Moderate Pain Management_ Managing Expectations and Outcomes (2005)

D00001045

TYLNJ 10587530-533

00/00/2005 Patient's Guide_ Safety and Efficacy Concerns in Mild-to- Moderate Pain Management_ Managing Expectations and Outcomes (2005)

D00001046 TYLNJ 10587432-502 1/0/2005 Tylenol Arthritis- Keep Moving (2005-Present)


D00001048 TYLNJ 05380561-0563 1/1/2005 Tylenol Extra Strength Print AdTYLEPM-0322



D00001050 TYLNJ 05380547 1/9/2005 Tylenol Jr Meltaways Coupon Print AdTYLEPM-0294

D00001051 TYLNJ 05380548 1/21/2005 Tylenol Extra Strength Rapid Release Gels Print AdTYLEPM-0302

D00001052 TYLNJ 05380558 1/23/2005 Tylenol Extra Strength Rapid Release Gel Print AdTYLEPM-0319


D00001054 TYLNJ 05380557 2/6/2005 Infant's Tylenol Coupon Print AdTYLEPM-0318




D00001058 TYLNJ 05380564 2/27/2005 Tylenol Scholarship Coupon Print AdTYLEPM-324

D00001059

3/00/2005U.S. Dept Health and Human Services. Guidance for Industry – Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

D00001060 TYLNJ 05380554-0555 3/1/2005 Tylenol Extra Strength Rapid Release Gels Print AdTYLEPM-0316

D00001061 TYLNJ 05380556 3/1/2005 Children's Tylenol Stop.Think. Print AdTYLEPM-0317




D00001065TYLNJ 10587534-545 4/00/2005

State of the Art Management of Mild-to-Moderate Pain_ Musculoskeletal Injuries and Analgesia (April 2005)

D00001066 TYLNJ 01538261-01540367 4/1/2005 McNeil Consumer Healthcare Clinical Study Report for Protocol 00-103: A randomized, double-blind, placebo-controlled study evaluating acetaminophen extended release (1950 mg/day and 3900 mg/day) in the treatment of osteoarthritis of the hip or knee. Fort Washington, PA: McNeil Consumer Healthcare, April 2005a (data on file).



D00001069 TYLNJ 05380582 4/24/2005 Tylenol Arthritis Pain Coupon Print AdTYLEPM-0441



D00001072 TYLNJ 04265246-74 4/29/2005 Leter to FDA regarding NDA 19-872


D00001073

TYLNJ 10587546-559 5/0/2005State of the Art Management of Mild-to-Moderate Pain_ Non-Opioid Analgesics in Managing OA Pain (May 2005)








D00001081TYLNJ 10587560-565 6/0/2005 APhA Self-Care Institute (Partnered with APhA) (June 2005)

D00001082 TYLNJ 01546108-7935 6/1/2005 McNeil Consumer Healthcare Clinical Study Report for Protocol 98-055: A randomized, double-blind, long-term comparative study evaluating the safety and efficacy of acetaminophen (4000 mg/day) and naproxen (750 mg/day) in the treatment of osteoarthritis of the hip or knee. Fort Washington, PA: McNeil Consumer Healthcare, June 2005b (data on file).





D00001087 TYLNJ 04265193-94 6/8/2005 Letter from FDA approving 19-872/S-023

D00001088 TYLNJ 04265190-92 6/10/2005 Letter to FDA regarding NDA 17-756, 19-872



D00001091 TYLNJ 05380597 6/21/2005 Tylenol Stop. Think. Print AdTYLEPM-0564

D00001092 TYLNJ 01540368-1387 7/1/2005 McNeil Consumer Healthcare Clinical Study Report for Protocol 00-104: A randomized, double-blind, placebo-controlled study evaluating acetaminophen extended release (3900 mg/day) in the treatment of osteoarthritis of the hip or knee. Fort Washington, PA: McNeil Consumer Healthcare, July 2005 (data on file).

D00001093 TYLNJ 05380598 7/1/2005 Tylenol Ouch Print AdTYLEPM-0565


D00001095 TYLNJ 05380602 7/1/2005 Tylenol Ouch Print AdTYLEPM-0574


D00001096TYLNJ 10587566-596 8/0/2005

State of the Art Management of Mild-to-Moderate Pain_ Multimodal Management of OA (August 2005)


D00001098 TYLNJ 04265179-80;TYLNJ 06312015 - 66;TYLNJ 06312060 - 84

8/18/2005

Letter to FDA regarding NDA 19-872


D00001100 TYLNJ 05380606 8/26/2005 Tylenol Rapid Release Gels Print AdTYLEPM-0597

D00001101TYLNJ 10587633-653 9/0/2005

Management of Mild-to-Moderate Osteoarthritic Pain (September 2005)

D00001102TYLNJ 10587597-599 9/0/2005

Pain Relievers_ Understanding Your OTC Options (Partnered with AAFP) (September 2005-Present)

D00001103TYLNJ 10587608-610 9/0/2005

OTC Drugs_ Getting the Most from Your Medicine (Partnered with AAFP) (September 2005-Present)

D00001104TYLNJ 10587611-614 9/0/2005

OTC Drugs_ Reducing the Risk of Adverse Effects (Partnered with AAFP) (September 2005-Present)

D00001105TYLNJ 10587615-618 9/0/2005

OTC Drugs_ Special Groups at Risk of Adverse Effects (Partnered with AAFP) (September 2005-Present)

D00001106 TYLNJ 10587619-632 9/0/2005 MyMedCab.com (September 2005-Present)


D00001108

TYLREP01720910-957

9/9/2005 An Analysis of Aminotransferase Values in Internal Clinical Studies of Acetaminophen



D00001111 TYLNJ 05380608 9/30/2005 Tylenol MedCab Makeover Print AdTYLEPM-0608



D00001114TYLNJ 10587654-666 11/0/2005

Pharmacy Times - OA Pain_ Clinical Practice Guidelines (November 2005)

D00001115

TYLNJ 10587667-690 11/0/2005State of the Art Management of Mild-to-Moderate Pain_ Musculoskeletal Injuries and OA Pain_ Optimizing Treatment Outcomes (November 2005)


D00001117 TYLNJ 05380613 11/4/2005 Tylenol Extra Strength EZ Tabs Coupon Print AdTYLEPM-0620

D00001118 TYLNJ 05380614 11/4/2005 Children's and Infant's Tylenol Coupon Print AdTYLEPM-0621

D00001119 TYLNJ 05380615 11/6/2005 Children's and Infant's Tylenol Coupon Print AdTYLEPM-0622



D00001122 TYLNJ 05380617 12/9/2005 Tylenol Coupon Print AdTYLEPM-0620


D00001123 TYLNJ 04273568-626 2006-2008 Acetaminophen ER Caplet, 650mg, NDA 19-872 Chrono Book


D00001125TYLNJ 06566146-70

00/00/2006 Patterns of Medication Use in the United States, A Report from the Slone Survey

D00001126TYLNJ 10587748-749

00/00/2006 Infants' and Children's Tylenol_ Professional Dosing Information (2006)

D00001127TYLNJ 10587750-752

00/00/2006 Pediatric Tylenol Cold Professional Dosing Information (2006)

D00001128 TYLNJ 10587755 00/00/2006 Pediatric Tylenol Cold Dosing Information (2006)

D00001129 TYLNJ 10587721-725 1/0/2006 Babycenter.com_ Healthy Spaces (2006-Present)

D00001130TYLNJ 10587726-747 1/0/2006

Tylenol.com_ Keeping Medicine Out of Reach (2006-Present)

D00001131 4/7/2005 FDA - Information for Healthcare Professionals: Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)



D00001134 TYLNJ 05380622 2/1/2006 Childrens' Tylenol Print AdTYLEPM-0635

D00001135 FDA - New Drug Application (NDA)


D00001137 TYLNJ 05380629 2/12/2006 Tylenol Extra Strength Coupon Contest Print AdTYLEPM-0654


D00001139 TYLNJ 09565003 2/17/2006 Tylenol NASCAR Contest Print AdTYLEPM-0661

D00001140 TYLNJ 05380633 3/1/2006 Tylenol Arthritis Print AdTYLEPM-0660

D00001141 TYLNJ 01519223 3/6/2006 McNeil Dr. Colleague Letter

D00001142 TYLNJ 05380639 3/26/2006 Tylenol Pm Coupon Print AdTYLEPM-0682


D00001144 TYLNJ 05380635 4/1/2006 Tylenol Arthritis Pain Print AdTYLEMP-0670

D00001145 TYLNJ 05380637-0638 4/1/2006 Tylenol Extra Strength Rapid Release Gels Print AdTYLEPM-0679

D00001146 6/00/2009 GAO Report to Congressional Requesters -- FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs




D00001149 TYLNJ 05380645 5/14/2006 Children's Tylenol Print AdTYLEPM-0714

D00001150 TYLNJ 06280909 5/14/2006 Tylenol Sinus Coupon Print AdTYLEPM-0708


D00001152 00/00/2003 Propoxyphene Napsylate and acetaminophen Label

D00001153TYLNJ 10587691-720 6/0/2006 APhA Self-Care Institute (Partnered with APhA) (June 2006)


D00001155 TYLNJ 05380648 6/4/2006 Tylenol Extra Strength Rapid Liquid Coupon Print AdTYLEPM-0721


D00001157TYLNJ 10587753-754 6/26/2006

Pediatric Tylenol Cold Professional Dosing Information Epocrates Doc Alert (2006)




D00001161 TYLNJ 04265150-51; TYLNJ 06312067 - 06312068

8/7/2006 Letter to FDA regarding NDA 19-872

D00001162 TYLNJ 10587756 8/15/2006 APAP McNeil Ed Binder, FDA Safe Use Binder 8/15/06

D00001163 TYLNJ 10587757-882 8/15/2006 FDA National Education Campaign 8_15_06

D00001164 TYLNJ 10587883-8071 8/15/2006 Proper Use of OTC Analgesics 8_15_06

D00001165 TYLNJ 05380652 9/10/2006 Tylenol Think Fast Coupon NASCAR Contest Print AdTYLEPM-0737



D00001168 TYLNJ 05380653 10/1/2006 Tylenol Stop.Think. Location Print AdTYLEPM-0740

D00001169 TYLNJ 05380654 10/1/2006 Tylenol GoTabs Coupon Print AdTYLEPM-0743

D00001170 TYLNJ 04265138 10/18/2006 Letter to FDA regarding Tylenol



D00001173

TYLNJ 05918553 11/3/2006Email from S Vassos (ALF) to E Kuffner, J Boyer, L Neier, regarding partnering on education, proposal regarding same.



D00001175 TYLNJ 04379176-99 11/10/2006 Letter from Nancy L. Buc and Kate C. Beardsley to Deborah Platt Majoras, Federal Trade Commission regarding response to July 12, 2006 Pharmacists Planning Service letter

D00001176 TYLNJ 05380661 11/12/2006 Children's Tylenol Meltaways Coupon Print AdTYLEPM-0767

D00001177 TYLNJ 05380660 11/12/2006 Tylenol GoTabs Coupon Print AdTYLEPM-0766

D00001178 TYLNJ 05380659 12/1/2006 Tylenol GoTabs Print AdTYLEPM-0764

D00001179TYLNJ 10586700-712 12/21/2006

Chronology of Tylenol Safety, Labeling & Educational Initiatives Index 1972-2006

D00001180 12/22/2006 12.22.06 Dietary Supplement and Nonprescription Drug Consumer Protection Act, Public Law 109-462

D00001181 12/26/2006 71 Fed Reg 77337

D00001182 12/26/2006 71 Fed Reg 77331

D00001183 12/26/2006 71 Fed Reg 77314-352


D00001185 00/00/2007 2007 Dietary Supplement and Nonprescription Drug Consumer Protection Act



D00001188 10/19/2012 FDA - Using Acetaminophen and Nonsteroidal Anti-inflammatory Drugs Safely

D00001189 TYLNJ 05380664 1/7/2007 Tylenol Winterize Your Medicine Cabinet Print AdTYLEPM-0790

D00001190 TYLNJ 04265131-33 1/8/2007 Letter to FDA regarding Meeting

D00001191

TYLNJ 04265128-30

1/29/2007 Lette from FDA regarding NDA 20-603, NDA 20-516, NDA 19-872, NDA 19-012, NDA 17-756

D00001192 TYLNJ 09565006 2/1/2007 Tylenol Stop. Think Print AdTYLEPM-0791


D00001194 2/5/2007 CDER Memo regarding OSE Safety Review

D00001195 4/21/2005 Ames v. Apothecon - Deposition of Cheryl Blume


D00001197 7/22/2005 Balser v. Astrazeneca - Trial Testimony of Cheryl Blume


D00001199 10/1/2009 Barton v. Wyeth (PM) - Trial Testimony of Cheryl Blume

D00001200 TYLMDL_HAYES_LABEL_00000001-2 Labels for Extra Strength Caplets (500 mg)




D00001203 00/00/1989 WHO Drug Information, Volume 3, Number 1

D00001204 4/27/2007 AASLD, Public comments to FDA


D00001206 TYLNJ 05380672 5/1/2007 Tylenol Arthritis Pain Stop. Think. Print AdTYLEPM-0866

D00001207

TYLNJ 07296579 5/4/2007Email from J Corwin (ALF) to J Baggish regarding ALF’s partnership proposal, and attached Partnership Proposal.


D00001209 TYLNJ 04265076-84 5/16-20/2007 Email to FDA regarding formulation tables


D00001211

5/24/2007

Statement of James L Boyer, M.D., on behalf of American Liver Foundation; http://www.fda.gov/ohrms/dockets/dockets/77n0094l/77n-0094L-c000005-vol1.pdf


D00001213 TYLNJ 04380650-946 5/25/2007 Response to Docket No. 1977N-0094L, FDA-Proposed Rule IAAA, McNeil Consumer Healthcare, Volume 1

D00001214 TYLNJ 03272875-3027 5/25/2007 Response to Docket No. 1977N-0094L, FDA-Proposed Rule IAAA, McNeil Consumer Healthcare, Volume 2



D00001217 TYLNJ 05745594-95 6/1/2007 Email from J . Baggish to J. Corwin regarding American Liver Foundation Partnership Proposal






D00001223 TYLNJ 07337742 8/15/2007 Responsible Use of Tylenol August 15, 2007



D00001226 TYLNJ 05380679 9/10/2007 Tylenol Rapid Release Print AdTYLEPM-0890

D00001227 TYLNJ 05380678 9/16/2007 Tylenol Rapid Release Coupon Print AdTYLEPM-0885

D00001228 TYLNJ 09565010 9/17/2007 Tylenol NASCAR Print AdTYLEPM-0889



D00001231 TYLNJ 04265023-25 10/2/2007 Letter to FDA regarding NDA 19-872/S029

D00001232 TYLNJ 04265019-22 10/12/2007 Letter to FDA regarding NDA 19-872/S029


D00001233 TYLNJ 04265013-14 10/30/2007 Letter from FDA regarding 19-872/S-028




D00001237 TYLNJ 04265007-10 12/6/2007 Letter to FDA regarding NDA 19-872/029

D00001238 TYLNJ 06280911 12/16/2007 Tylenol Cold Coupon Print AdTYLEPM-0949

D00001239 TYLNJ 04265004 12/17/2007 Letter to Neel Patel regarding NDA 19-872/S-029


D00001241 00/00/1997 WHO Drug Information, Volume 11, Number 2


D00001243 TYLNJ 04264998-99 1/4/2008 Email to FDA regarding NDA 19-872/S-029


D00001245 1/15/2008 Proposed amendments to regulationsD00001246

TYLNJ 04264984 1/24/2008 Correspondence from FDA regarding NDA 19-872/S-029D00001247 TYLNJ 04264979-83 1/25/2008 Letter to FDA regarding NDA 19-872/S-029D00001248 TYLNJ 04264974-78 1/28/2008 Letter to FDA regarding NDA 19-872/S-029D00001249 TYLNJ 09565011 2/3/2008 Tylenol Sinus and Cold Coupon Print Ad

TYLEPM-1008

D00001250 10/2/2009 Barton v. Wyeth (AM) - Trial Testimony of Cheryl Blume

D00001251 10/2/2009 Barton v. Wyeth (PM) - Trial Testimony of Cheryl Blume

D00001252 10/9/2009 Barton v. Wyeth (AM) - Trial Testimony of Cheryl Blume

D00001253 9/15/2011 Beare_Gaffney v. J&J - Trial Testimony of Cheryl Blume

D00001254 TYLNJ 05380684 2/10/2008 Tylenol NASCAR Contest Coupon Print AdTYLEPM-0961

D00001255 9/16/2011 Beare_Gaffney v. J&J - Trial Testimony of Cheryl Blume

D00001256 1/11/2007 Daniel v. Wyeth - Trial Testimony of Cheryl Blume

D00001257 3/12/2012 Decker v. GE Healthcare - Trial Testimony of Cheryl Blume

D00001258 11/9/2005 Garcia v. Bayer - Deposition of Cheryl Blume

D00001259 5/9/2012 Gardner Moss v. Wyeth (AM) - Trial Testimony of Cheryl Blume

D00001260 5/9/2012 Gardner Moss v. Wyeth (PM) - Trial Testimony of Cheryl Blume


D00001262 5/10/2012 Gardner Moss v. Wyeth (PM) - Trial Testimony of Cheryl Blume


D00001264 4/11/2013 Glynn v. Merck - Trial Testimony of Cheryl Blume

D00001265 2/26/2003 Haltom v. Bayer (AM) - Trial Testimony of Cheryl Blume

D00001266 2/26/2003 Haltom v. Bayer (PM) - Trial Testimony of Cheryl Blume


D00001267 2/27/2003 Haltom v. Bayer (AM) - Trial Testimony of Cheryl Blume

D00001268 2/27/2003 Haltom v. Bayer (PM) - Trial Testimony of Cheryl Blume

D00001269 11/17/2006 In re Accutane - Deposition of Cheryl Blume

D00001270 7/9/2010 In re Levaquin - Deposition of Cheryl Blume

D00001271 TYLNJ 04264969-73 2/15/2008 Letter to FDA regarding NDA 19-872/S-029D00001272 12/19/2006 In re Accutane - Deposition of Cheryl Blume



D00001275 12/21/2012 In re Fosamax - Deposition of Cheryl Blume

D00001276 1/12/2007 In re Neurontin - Deposition of Cheryl Blume

D00001277 TYLNJ 05380687 2/18/2008 Tylenol Extra Strength Feel Better Print AdTYLEPM-0968


D00001279 11/21/2002 Haltom v. Bayer - Deposition of Cheryl Blume

D00001280 2/10/2003 Haltom v. Bayer - Deposition of Cheryl Blume

D00001281 8/24/2004 Gaskins v. American Home Products - Deposition of Cheryl Blume

D00001282 9/2/2004 Langstaff v. McNeil - Deposition of Cheryl Blume

D00001283 12/7/2007 Decker v. Indevus Pharmaceuticals - Deposition of Cheryl Blume

D00001284 TYLNJ 04264950-68 2/26/2008 Letter to FDA regarding NDA 19-872/S-030D00001285 TYLNJ 04469378-642 2/26/2008 Recommendations for FDA Interventions to Decrease the

Occurrence of Acetaminophen Hepatotoxicity (CDER)


D00001287 TYLNJ 02496024-32 2/28/2008 Letter from FDA regarding NDA 19-872/S-029D00001288 TYLNJ 05380689 3/1/2008 Tylenol Extra Strength Feel Better Print Ad

TYLEPM-0973

D00001289 TYLNJ 05380690 3/1/2008 Tylenol Feel Better Print AdTYLEPM-0976

D00001290 TYLNJ 05380691 3/1/2008 Tylenol Feel Better Print AdTYLEPM-0977

D00001291 8/23/2004 Bice v. Wyeth - Deposition of Cheryl Blume

D00001292 2/21/2014 Kendall v. Hoffman-La Roche - Trial Testimony of Cheryl Blume

D00001293 8/31/2004 St. Martin v. Wyeth - Deposition of Cheryl Blume

D00001294 3/9/2005 Curry v. Wyeth - Deposition of Cheryl Blume

D00001295 TYLNJ 04264940-48 3/5/2008 Letter from FDA approving NDA 19-872/S-029D00001296 10/26/2006 In re Diet Drug - Deposition of Cheryl Blume

D00001297 10/20/2005 Palazzolo v. Hoffman-La Roche - Deposition of Cheryl Blume

D00001298 12/28/2004 Gordon v. Wyeth - Deposition of Cheryl Blume

D00001299 9/2/2004 Langstaff v. McNeil - Deposition of Cheryl Blume

D00001300 2/12/2005 Brigman - Deposition of Cheryl Blume

D00001301 12/16/2013 Accutane - Deposition of Laura Plunkett


D00001302 TYLNJ 06280912 3/16/2008 Tylenol Cold and Sinus Rapid Release Coupon Print AdTYLEPM-1022

D00001303 6/5/2006 Anderson v. Merck - Deposition of Laura Plunkett

D00001304 6/18/2007 Armendarez v. Wyeth - Deposition of Laura Plunkett

D00001305 6/1/2006 Arringale v. Merck - Deposition of Laura Plunkett

D00001306 11/19/2002 Blanco v. Wyeth - Deposition of Laura Plunkett

D00001307 8/12/2004 Blanco v. Wyeth - Deposition of Laura Plunkett

D00001308 3/7/2011 Brakefield v. McNeil - Trial Testimony of Laura Plunkett

D00001309 9/8/2011 Brakefield v. McNeil - Deposition of Laura Plunkett

D00001310 11/19/2002 Carter v. AHP - Deposition of Laura Plunkett

D00001311 12/19/2002 Crater v. Wyeth - Deposition of Laura Plunkett

D00001312 2/19/2013 Esterbrook v. Hoffman-La Roche - Deposition of Laura Plunkett

D00001313 10/6/2009 Foti v. Janssen - Deposition of Laura Plunkett

D00001314 TYLNJ 05380696 5/1/2008 Tylenol Arthritis Pain Feel Better Print AdTYLEPM-1072

D00001315 TYLNJ 04273622-26; TYLNJ 04264935-39 5/5/2008 Letter to FDA regarding NDA 19-872/S-029

D00001316 1/6/2004 Freeman v. Bayer - Deposition of Laura Plunkett

D00001317 TYLNJ 04265474 5/23/2008 Letter to the FDA regarding NDA 19-872

D00001318 2/23/2006 Geers v. Wyeth - Trial Testimony of Laura Plunkett

D00001319 11/17/2009 Gerber v. Bayer - Deposition of Laura Plunkett

D00001320 TYLNJ 05380699 6/17/2008 Tylenol PM Feel Better Print AdTYLEPM-1086

D00001321 TYLNJ 05380700 6/20/2008 Tylenol NASCAR Rapid Release Coupon Print AdTYLEPM-1091

D00001322 TYLNJ 09565012 7/1/2008 Body.aol.com/better-living sponsored y Tylenol Print AdTYLEPM-1082

D00001323 3/25/2003 Hardy v. Baycol - Trial Testimony of Laura Plunkett

D00001324 7/16/2004 Havey v. Sears - Deposition of Laura Plunkett

D00001325 10/5/2004 Hooten v. AHP - Deposition of Laura Plunkett

D00001326 10/25/2002 Kay v. AHP - Deposition of Laura Plunkett

D00001327 12/19/2002 Kay v. AHP - Deposition of Laura Plunkett

D00001328 8/24/2011 Newman v. McNeil - Deposition of Laura Plunkett

D00001329 8/12/2004 Kult v. Wyeth - Deposition of Laura Plunkett

D00001330 8/12/2004 Solez v. Wyeth - Deposition of Laura Plunkett


D00001332 TYLNJ 04273614-16 8/6/2008 Letter to FDA regarding NDA 19-872D00001333 TYLNJ 06288984 - 993;

TYLNJ 04273617-21 8/7/2008 Letter to FDA regarding NDA 19-872D00001334 TYLNJ 04273609-11 8/7/2008 Letter to FDA regarding NDA 19-872D00001335 There is no Exhibit


D00001337 TYLNJ 04273604-06 8/19/2008 Letter to FDA regarding NDA 19-872D00001338 8/22/2008 73 Fed Reg 49603



D00001340 11/9/2004 Spencer v. Duramed - Deposition of Laura Plunkett

D00001341 3/27/2003 Strong v. Bayer - Deposition of Laura Plunkett

D00001342 6/20/2006 Miller v. Merck - Deposition of Laura Plunkett

D00001343 TYLNJ 05380706 9/14/2008 Tylenol NASCAR Rapid Release Coupon Print AdTYLEPM-1134

D00001344 5/25/2004 Turney v. Novartis - Deposition of Laura Plunkett

D00001345 10/19/2004 Turney v. Novartis - Deposition of Laura Plunkett

D00001346 TYLNJ 05380709 10/1/2008 Children's Tylenol Feel Better Print AdTYLEPM-1147

D00001347 TYLNJ 05380707 10/1/2008 Tylenol Arthritis Pain Feel Better Print AdTYLEPM-1136

D00001348 12/4/2002 Villareal v. AHP - Deposition of Laura Plunkett

D00001349 2/3/2004 Vogt v. AHP - Deposition of Laura Plunkett

D00001350 5/18/2005 Vogt v. AHP - Deposition of Laura Plunkett

D00001351 TYLNJ 05380716 10/18/2008 Tylenol and Clorox Flu Season Coupon Print AdTYLEPM-1171

D00001352 TYLNJ 05380712 10/20/2008 Tylenol Children's Feel Better Print AdTYLEPM-1161

D00001353 10/2/2008 In re Seroquel - Deposition of Laura Plunkett

D00001354 10/21/2008 In re Seroquel - Deposition of Laura Plunkett

D00001355 TYLNJ 05997567-71 10/24/2008 Tylenol Litigation Key Historical Reel 1976-2003


D00001357 TYLNJ 05380714-0715 11/1/2008 Tylenol Feel Better Print Ad (Liver Ad)TYLEPM-1170

D00001358 10/21/2009 Kendall v. Wyeth - Trial Testimony of Cheryl Blume


D00001360 TYLNJ 04273589-93 11/7/2008 Letter to FDA regarding NDA 19-872D00001361 TYLNJ 05380719 11/9/2008 Tylenol Arthritis Feel Better Coupon Print Ad

TYLEPM-1180

D00001362 TYLNJ 05380718 11/9/2008 Tylenol Feel Better Coupon Print AdTYLEPM-1179

D00001363 8/25/2009 Ford v. Alza

D00001364 TYLNJ 04273578-81 12/5/2008 Letter to FDA regarding NDA 19-872D00001365 10/22/2009 Kendall v. Wyeth - Trial Testimony of Cheryl Blume



D00001368 10/17/2007 Kunneman v. Janssen - Deposition of Cheryl Blume

D00001369 TYLNJ 04273574-77 12/17/2008 Letter to FDA regarding NDA 19-872D00001370 TYLNJ 04273569-73 12/22/2008 Waiver Requests, NDA 19-872

D00001371 TYLNJ 02917733 12/22/2008 Waiver Requests, NDA 19-872

D00001372 TYLNJ 02164838 00/00/2009 Tylenol Extra Strength label


D00001374 TYLNJ 04273341-567 00/00/2009 Acetaminophen ER Caplet, 650mg, NDA 19-872 Chrono Book

D00001375 10/1/2002 Lehr v. Merck - Deposition of Cheryl Blume


D00001376 8/22/2007 Mason v. Hoffman-La Roche - Deposition of Cheryl Blume

D00001377 9/28/2007 Mason v. Hoffman-La Roche - Deposition of Cheryl Blume

D00001378 10/1/2007 Mason v. Hoffman-La Roche - Trial Testimony of Cheryl Blume

D00001379 5/15/2007 McCarrell v. Hoffman-La Roche - Deposition of Cheryl Blume

D00001380 1/27/2010 McCarrell v. Hoffman-La Roche - Trial Testimony of Cheryl Blume



D00001383 TYLNJ 04273563-67 1/16/2009 Letter from FDA regarding NDA 19-872D00001384 6/6/2006 Mefford v. Ortho-McNeil - Deposition of Cheryl Blume

D00001385 1/11/2007 Nelson v. Wyeth - Trial Testimony of Cheryl Blume



D00001388 TYLNJ 04273563-67 1/20/2009 FDA Approval Letter, NDA 19-872

D00001389 TYLNJ 001171949-01171976 1/20/2009 FDA Approval Letter, NDA 19-872

D00001390 4/6/2005 Olsen v. Wyeth - Trial Testimony of Cheryl Blume

D00001391 9/22/2009 Peipert v. Hoffman-La Roche - Deposition of Cheryl Blume

D00001392 TYLNJ 02473554-57 2/3/2009 Letter from FDA regarding NDA 19-872D00001393 9/10/2010 Rosenberg v. Merck - Deposition of Cheryl Blume

D00001394 TYLNJ 04273558-62 2/13/2009 Letter to FDA regarding NDA 19-872/S-031D00001395 1/30/2008 Rosensweig v. Hoffman-La Roche - Deposition of Cheryl

Blume

D00001396 9/17/2007 Rowatt v. Wyeth - Trial Testimony of Cheryl Blume

D00001397 TYLNJ 04273553 2/20/2009 Record of Contact D00001398 9/18/2007 Rowatt v. Wyeth - Trial Testimony of Cheryl Blume

D00001399

TYLNJ 07231041-43 2/23/2009FDA Consumer Health Information - A Guide to Safe Use of Pain Medicine

D00001400 11/16/2010 Schedin v. J&J - Deposition of Cheryl Blume

D00001401 5/1/2007 Simon v. Wyeth - Trial Testimony of Cheryl Blume

D00001402 5/1/2007 Simon v. Wyeth - Trial Testimony of Cheryl Blume

D00001403 TYLNJ 04273552 3/25/2009 Record of Contact D00001404 5/12/2010 Smith v. Pfizer - Deposition of Cheryl Blume

D00001405 11/21/2008 Vance v. Rite Aid - Deposition of Cheryl Blume

D00001406 TYLNJ 04273547-51 4/2/2009 Letter to FDA regarding NDA 19-872D00001407 5/25/2010 Weathersbee v. Hoffman-La Roche - Deposition of Cheryl

Blume

D00001408 TYLNJ 04273546 4/8/2009 Record of Contact D00001409 TYLNJ 04273539 4/14/2009 Record of Contact D00001410 10/6/2010 Wilson v. Wyeth - Trial Testimony of Cheryl Blume

D00001411 TYLNJ 02628987-90 4/27/2009 Letter to FDA regarding 75 Fed Reg 8798


D00001412 TYLNJ 04273530-34; TYLNJ 03118887-88; TYLNJ 06288994 - 06292233 4/29/2009 Letter to FDA regarding NDA 19-872

D00001413 4/29/2009 74 Fed Reg 19385-409


D00001415 10/7/2010 Wilson v. Wyeth - Trial Testimony of Cheryl Blume

D00001416 3/18/2010 Woodson v. Abousy - Deposition of Cheryl Blume

D00001417 1/26/2005 In re Paxil - Deposition of Cheryl Blume


D00001419 1/27/2005 In re Paxil - Deposition of Cheryl Blume Vol. I

D00001420

TYLNJ 07453057-075

5/21/2009 Analyses of US Multiple-Cause-of-Death Tapes from 1999 through 2006, with Estimated Changes in the Numbers of Deaths Caused by Analgesic-Associated Adverse Events if Acetaminophen Users Switch to NSAID Use because of Package Restrictions



D00001423 1/27/2005 In re Paxil - Deposition of Cheryl Blume Vol. II

D00001424 4/7/2006 In re Prempro - Deposition of Cheryl Blume


D00001426 6/0/2009 FDA Patient Safety News http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=87

D00001427 6/0/2009FDA - Acetaminophen and Liver Injury: Q&A for Consumers

D00001428 6/0/2009 Meeting Announcement for June 29-30, 2009 NDAC Joint Meeting of Advisory Committee meetings including background information and agenda.http://www.fda.gov/AdvisoryCommittees/Calendar/ucm143083.htm





D00001433 7/21/2011 In re Traysol - Deposition of Cheryl Blume





D00001438 TYLNJ 04273494-500; TYLNJ 02540532-38



D00001440 6/29/2009 2009 AdCom MeetingTranscript

D00001441 6/29/2009 FDA's Slide Presentation for Advisory Committee Meeting

D00001442 TYLNJ 07572320-38 6/29-30/2009 Summary of Minutes


D00001443 TYLNJ 02505577-825 6/29-30/2009 McNeil's Briefing Materials; Backgrounder

D00001444 TYLNJ 03270214-277 6/29-30/2009 McNeil's PowerPoint Presentation

D00001445 6/30/2009 2009 AdCom Meeting Transcript

D00001446

6/30/2009

Presentation of Keith Hawton, Dir. for Suicide Res. at Warneford Hospital in Oxford, Tr. of FDA Advisory Comm. Mtg., at 26 (June 30, 2009); http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM171600.pdf

D00001447 TYLNJ 02630836-37 6/30/2009 Media Statement

D00001448 7/00/2009 Guidance for Industry; Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

D00001449 7/00/2009 Guidance for Industry, Drug-Induced Liver Injury: Premarketing Clinical Evaluation

D00001450 TYLNJ 04480083-97 7/29/2009 Letter to FDA regarding OTC Acetaminophen Products



D00001453

TYLNJ 05547686-87

8/11/2009 Correspondence with FDA regarding OTC Acetaminophen





D00001458 TYLNJ 04273459-67; TYLNJ 02579926-34





D00001462 TYLNJ 05694517-38 9/30/2009 Letter to FDA regarding Docket No. FDA-2009-N-138










D00001472 11/4/2009 FDA's Safe Use Initiative




D00001476 TYLNJ 03187825-29 11/24/2009 Letter to FDA regarding OTC Acetaminophen products

D00001477 11/25/2009 74 Fed Reg 61512





D00001481

TYLNJ 04273444-47 12/7/2009SNDA providing for organ-specific warnings on Tylenol extended release caplets, NDA 19-82/S-033, Amendment #1

D00001482TYLNJ 04273441-43 12/16/2009

McNeil submits Quarterly Report re: Tyl Arthritis Pain, NDA 19-872



D00001485TYLNJ 04484710-14 12/23/2009

Michael Levy - Covington & Burling LLP - Extra-Strength Caplet Label

D00001486 TYLNJ 04484715-17 12/24/2009 Correspondence - Letter re Tylenol PM



D00001489 00/00/2010 Tylenol Professional Product Information

D00001490 TYLNJ 04273437-40 1/8/2010 McNeil memo to FDA re: NDA 19-872/S-034

D00001491TYLNJ 09341202-09 1/8/2010

Observations Noted by the FDA during an inspection of McNeil’s Drug Manufacturer in Puerto Rico



D00001494TYLNJ 09341170-201 2/5/2010 McNeil response to FDA's 10.22.2009-1.8.2010 Inspection


D00001496TYLNJ 04273426-29 2/19/2010

Memo from FDA to McNeil re: SNDA Tylenol extended release caplets label, NDA 19-872/S-033

D00001497 TYLNJ 03278344-404 2/23/2010 McNeil presents Risk Mitigation plan to FDA

D00001498TYLNJ 04273430-33 2/24/2010

FDA memo to McNeil acknowledging receipt of SNDA, NDA 19-872/S-034


D00001500 TYLNJ 04273423-25 3/4/2010 McNeil memo to FDA re: NDA 19-872

D00001501TYLNJ 04273407-11 3/26/2010

Memo from McNeil to FDA re: NDA 19-872 Amendment #1 to Changes Being Effected (S-033)

D00001502

TYLNJ 04273412-16 3/30/2010FDA memo to McNeil re: McNeil’s SNDA providing for organ specific warnings on Tylenol extended release caplets, NDA 19-872/S-033

D00001503TYLNJ 04273404-06 4/14/2010 Memo from McNeil to FDA re: NDA 19-872/S-034, Am. #2

D00001504 TYLNJ 04273396-99TYLNJ 06292234-777TYLNJ 06298778 -9743

4/28/2010 Memo from McNeil to FDA re: Periodic Safety Update Report

D00001505

4/29/2010Effective Date of Final Rule re: Organ-Specific Warnings

D00001506TYLNJ 04273369-81 5/6/2010

Memo from FDA to McNeil re: Approval of SNDA for revised labeling, NDA 19-872/S-033


D00001507

TYLNJ 04273363-68

5/10/2010 Memo from FDA regarding approval of NDA 19-872/S-034

D00001508TYLNJ 04273363-68 5/10/2010

Memo from FDA to McNeil re: Approval of SNDA for tablet color change, NDA 19-872/S-034

D00001509 TYLNJ 04486289-292 6/10/2010 Letter from FDA regarding Risk Mitigation Plan meeting

D00001510 TYLNJ 04486289-292 6/10/2010 FDA responds to McNeil’s November 24, 2009 letter.

D00001511TYLNJ 04273359-62 6/14/2010

Memo from McNeil to FDA re: NDA 19-872, Quarterly Safety Report


D00001513TYLNJ 04484722-24 6/17/2010

Email from G. Masoudi re: Dr. Ganley's letter of June 10, 2010

D00001514TYLNJ 04484722-24 6/29/2010

Email from H. Gertner re: Dr. Ganley's letter of June 10, 2010

D00001515 TYLNJ 04484722-24 6/29/2010 Letter regarding Risk Mitigation Plan meeting

D00001516

7/00/2010

Guidance for Industry; Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use – Small Entity Compliance Guide


D00001518 TYLNJ 02550125-26 7/20/2010 Letter to FDA regarding Risk Mitigation Plan

D00001519TYLNJ 04485406-07 7/28/2010

Email from P. Luther to J. Woodcock re: McNeil Risk Mitigation Plan Update

D00001520 TYLNJ 04485406-07 7/30/2010 Letter regarding Risk Mitigation Plan

D00001521 TYLNJ 04485409 8/2/2010 Letter from L. Pawelski

D00001522TYLNJ 03291786-87 8/4/2010

Email from J. Woodcock to P. Luther re: Risk Mitigation Plan Update

D00001523TYLNJ 04273357-58 8/6/2010

Memo from McNeil to FDA re: NDA 19-872 Annual Report No. 16


D00001525 TYLNJ 03291786-87 8/20/2010 Letter from L. Pawelski regarding proposed language

D00001526TYLNJ 06021514-541 8/31/2010

Trend Analysis re: Post-Marketing Events re: Tyl Arthritis Pain

D00001527TYLNJ 05700329-30 10/6/2010

McNeil meets with FDA to discuss McNeil’s final implementation of its Risk Management plan.

D00001528 TYLNJ 03278833-36 10/7/2010 Email from Lynn Pawelski to FDA re: Acetaminophen

D00001529TYLNJ 06021510-13 10/7/2010

Memo from McNeil to FDA re: NDA 18-872: Quarterly Safety Report

D00001530 TYLNJ 02628816 10/8/2010 Record of Contact re: Risk Mitigation Plan

D00001531TYLNJ 06021542-44 10/8/2010

McNeil notifies FDA that it is converting NDA 19-872 from paper format to Electronic format.

D00001532 TYLNJ 02550153-58 10/9/2010 Record of Contact regarding Tylenol

D00001533

10/14/2010•American Association for the Study of Liver Diseases publishes article regarding indeterminate causes of acute liver failure (ALF).

D00001534TYLNJ 03278833-36 10/18/2010 Email from S. Johnson to L. Pawelski re: Dosing Interval

D00001535 TYLNJ 03278833-36 10/18/2010 Email from FDA to Lynn Pawelski re: Acetaminophen


D00001536 TYLNJ 03278833-36 10/19/2010 Email from FDA regarding dosing interval

D00001537 TYLNJ 03278833-36 10/19/2010 Email from Lynn Pawelski to FDA re: Acetaminophen

D00001538 10/25/2010 FDA Safe Use Initiative - Acetaminophen Toxicity http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ucm230396.htm

D00001539TYLNJ 06021548-50 10/27/2010

FDA acknowledgement of receipt of McNeil’s SNDA, NDA 19-872/S-035

D00001540TYLNJ 05700329-30 11/2/2010


D00001541TYLNJ 05700329-30 11/2/2010

Email from J. Woodcock to P. Luther re: Risk Mitigation Plan Update

D00001542 TYLNJ 05700329-30 11/3/2010 Email from P. Luther regarding Risk Mitigation Plan

D00001543 11/16/2010 FDA Safe Use Initiative Public Workshop Slides

D00001544TYLNJ 06021551-53 11/23/2010

Tylenol 650mg Extended Release Tablets; NDA 19-872 General Correspondence

D00001545 TYLNJ 06021554-58 12/13/2010 Letter from McNeil regarding Risk Management Plan

D00001546 TYLNJ 06020105-122 &TYLNJ 06021559-63 12/22/2010

McNeil submits Final Printed Labeling for Tylenol Arthritis Pain 650 mg acetaminophen extended release caplets.


D00001548 TYLNJ 05670945 1/5/2011 Monograph Labeling – New Warnings

D00001549 1/13/2011 Transcript of FDA Media Briefing on Acetaminophen in Prescription Products

D00001550 1/14/2011 76 Fed Reg 2691

D00001551 TYLNJ 06021564-67 2/1/2011 McNeil submits Quarterly Safety Report, NDA 19-872

D00001552TYLNJ 06021568-69 2/16/2011

FDA approves CBE for sNDA 19-872/S-035 providing for additional testing

D00001553TYLNJ 09386401-16 3/17/2011

Data Supporting On-Cap Messaging for Consumer Labeling of Acetaminophen-Containing OTC Products

D00001554 TYLNJ 06299744 – 06304268 4/18/2011 Periodic Safety Update Report

D00001555TYLNJ 06304269 - 06304758 4/18/2011 List of FDA Appendices from Periodic Safety Update Report



D00001558

TYLNJ 05721629-2039

5/17/2011Transcript of Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee

D00001559 5/18/2011Transcript of Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee

D00001560TYLNJ 06021582-86 6/23/2011 Letter to FDA regarding Prior Approval Labeling Supplement


D00001562 7/1/2011 Reducing Fever in Children - Safe Use of Acetaminophen

D00001563 7/7/2011 76 Fed Reg 40052


D00001564 7/7/2011 76 Fed Reg 40058

D00001565 7/21/2011 FDA - Reducing Fever in Children: Safe Use of Acetaminophenhttp://www.fda.gov/ForConsumers/ConsumerUpdates/ucm263989.htm

D00001566 TYLNJ 09820882-885 7/22/2011 Letter to FDA re: Risk Mitigation Plan

D00001567TYLNJ 05702364-66 7/27/2011

Email from L. Pawelski to S. Kweder re: Acetaminophen Risk Mitigation Plan

D00001568TYLNJ 06269479-80

7/28/2011 Dear Healthcare Provider Letter regarding reducing dosage for XS Tylenol effective Fall 2011

D00001569 TYLNJ 06269479-80 7/28/2011 Press Release


D00001571TYLNJ 03291786-87 8/11/2011


D00001572 TYLNJ 04194839-60 9/7/2011 Letter to FDA re: 19-872

D00001573 9/19/2011 September 19, 2011 Guidance for FDA Staff and Industry, Marketed Unapproved Drugs - Compliance Policy Guide

D00001574 TYLNJ 08125837 10/6/2011 Letter to FDA re: OTC APAP Products

D00001575 10/11/2001 Memo from S.R. Ahmad to C. Ganley. OPDRA Safety Review-Review of acetaminophen poisoning exposures in Toxic Exposure Surveillance System (TESS), PID#D010092. (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882b1.htm, last visited 5/20/2014)

D00001576TYLNJ 08125618-836 10/25/2011

Acetaminophen Risk Mitigation Plan Pre-Meeting Briefing Package



D00001579 TYLNJ 06021606-620; TYLNJ 06021599-605

12/13/2011 Letter to FDA regarding NDA 19-872/S-036

D00001580

TYLNJ 07360907-76

12/14/2011 Correspondence from Victoria Wagner-Weber to FDA regarding results of McNeil study ACEPAI201

D00001581 TYLNJ 06021606-20 12/23/2011 Letter from FDA re: NDA 19-872/S-036


D00001583 TYLNJ 07079711-9728 3/13/2012 Pediatric Acetaminophen Increasing Safe Use March 14, 2012

D00001584 TYLNJ 06304759 - 7691 4/10/2012 Periodic Safety Update Report

D00001585 TYLNJ 06917732 4/12/2012 Tylenol Regular Strength label



D00001588 4/27/2012 FDA - Health Bulletin: Use Caution with Pain Relievers

D00001589 TYLNJ 06021627-28 5/24/2012 Letter to FDA regarding change in personnel

D00001590 TYLNJ 09338888-926 6/5/2012 McNeil memo re: New Product Drug Listing/Product De-Listing

D00001591 6/20/2012 Exhibit 11 to Sherri Cathcart Deposition


D00001592 6/20/2012 Exhibit 11.1 to Sherri Cathcart Deposition

D00001593 6/20/2012 Exhibit 11.2 to Sherri Cathcart Deposition




D00001597 TYLNJ 09223405 6/20/2012 McNeil Memo re: Product Drug Listing for Jr. Tylenol Grape Meltaways

D00001598 TYLNJ 09222952 6/20/2012 McNeil Memo re: Product Drug Listing for Jr. Tylenol Grape Meltaways

D00001599 7/1/2012 Draft Guidance for Industry

D000016007/5/2012

Email from L. Pawelski to V. Wagner-Weber re: Acetaminophen Liver Warning

D00001601 TYLNJ 09338881-87 3/18/2004 Letter to Division of OTC Drug products regarding Final Printed Labeling SNDA S-018 CBE-30

D00001602 TYLNJ 09223315 7/11/2012 McNeil Memo re: Product Drug Listing for Jr. Tylenol Grape Punch Meltaways



D00001605 TYLNJ 09320396-99 9/24/2012 Letter to FDA re: OTC APAP

D00001606 TYLNJ 09223589 10/2/2012 McNeil Memo re: New Product Drug Listing/Product De-listing for Tylenol Allergy Multi-Symptom Nighttime – Cool Burst Caplets


D00001608 10/19/2012 FDA - Why is it important to know that all these medicines contain acetaminophen?

D00001609 10/19/2012 FDA - Careful: Acetaminophen in pain relief medicines can cause liver damage.

D00001610 10/19/2012 FDA - The best way to take your over-the-counter pain reliever? Seriously.

D00001611 10/19/2012 FDA - Too much acetaminophen can destroy your liver.

D00001612 10/19/2012 FDA - How can a pain reliever lead to serious liver damage?

D00001613 TYLNJ 06356793-907 10/24/2012 Postmarketing Surveillance Ad Hoc Report on the Impact of Dose and Liver Abnormalities in Users of Paracetamol (Acetaminophen)

D00001614 TYLNJ 05997318 10/30/2012 McNeil call to FDA re: status of NDA 19-872/S-013


D00001616 TYLNJ 06021648-50 11/9/2012 Letter from FDA re: NDAs 19012/S-50 and 19872/S-38


D00001618 00/00/2013 US Food and Drug Administration. (2013). Postmarketing reporting of adverse drug experiences. Code of Federal Regulations, § 314.80, 120-124.; 21 CFR 314.80

D00001619 TYLNJ 09223150 1/14/2013 McNeil Memo re: New Product Drug Listing/Product De-Listing for Children’s Tylenol Suspension Dye Free Cherry Blast


D00001620 TYLNJ 09223129 1/16/2013 McNeil memo re: New Product Drug Listing/Product De-Listing for Children’s Tylenol Plus Cough & Sore Throat

D00001621 TYLNJ 09218627 1/23/2013 McNeil Memo re: new product listing/product de-listing for Tylenol Sinus Congestion and Pain Caplets

D00001622 1/24/2013 FDA Consumer Updates: Don’t Double Up on Acetaminophen http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm336581.htm

D00001623 1/31/2013 FDA Safe Use Initiative - NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen

D00001624 TYLNJ 06357561-772 2/28/2013 Letter to FDA regarding Docket No. FDA-2009-N-0138

D00001625 TYLNJ 06021657-58 3/8/2013 Letter from FDA re: NDA 019872/S-037

D00001626 3/11/2013 How FDA strives to ensure the safety of OTC products (http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm342560.htm)



D00001629 3/31/2013 SOP-08759: Collection, Processing and Reporting of J&J Consumer Product Individual Case Safety Reports

D00001630 4/1/2013 21 CFR 201.56

D00001631 4/1/2013 21 CFR 201.80e

D00001632 TYLNJ 09223632 4/22/2013 McNeil Memo re: New Product Drug Listing/Product De-Listing for Tylenol Cold Head Congestion Severe Caplets

D00001633 TYLNJ 06021684-87 4/24/2013 Letter from FDA re: NDA 19-872

D00001634 TYLNJ 09223289 4/29/2013 McNeil Memo to Drug Listing File and Johnson & Johnson Pharm. Re: Manufacturer’s Drug Listing for Product shipping to US

D00001635 TYLNJ 06021169-78 6/20/2013 Submission regarding NDA 19-872/S-039


D00001637 TYLNJ 06021172-78 7/17/2013 Annotated Draft Labeling Text

D00001638 TYLNJ 06021695-97 7/17/2013 Letter from FDA re: NDA 019872/S-039

D00001639 TYLNJ 06308600 - 06310712 7/17/2013 Periodic Safety Update Report

D00001640 7/18/2013 FDA Blog - FDA Voice - FDA Reminds Consumers to Always Use Acetaminophen Safely http://blogs.fda.gov/fdavoice/index.php/tag/acetaminophen-safety/


D00001642 8/6/2013 Letter to FDA re: NDA 19-872

D00001643

8/6/2013FDA Safe Use Initiative; fda.gov/drugs/drugsafety/safeuseinitiative/ucm230396.htm

D00001644 TYLNJ 08690809-16 9/25/2013 Letter from FDA regarding IND 118460

D00001645 TYLNJ 09223210 12/16/2013 McNeil memo to Drug Listing File, Jansen Cilag SpA, Latina, Italy & Johnson & Johnson re: Manufacturer’s Drug Listing for Product shipping to United States


D00001646 TYLNJ 09223511 12/16/2013 McNeil Memo to Drug Listing File, Janssen Cilag SpA, Latina Italy & Johnson & Johnson from Cheryl Sikoli re: Manufacturer’s Drug Listing for Product shipping to United States

D00001647 TYLNJ 09223783 12/23/2013 McNeil memo to Drug Listing File, Janssen Cilag SpA, Latina, Italy and Johnsons & Johnson from Cheryl Sikolia re: Manufacturer’s Drug Listing for Product shipping to United States

D00001648 1/14/2014 FDA Prescription APAP Recommendation

D000016491/22/2014

Dear Healthcare Provider Guidance for Industry and FDA Staff

D00001650 TYLREP01129717-18 1/22/2004 FDA News Release

D00001651 TYLNJ_NIH_FOIA_00000001-570 3/19/2014 William Lee Documents pursuant to FOIA - 3.19.14



D00001654 5/00/2014 FDA Consumer Health Information Article

D000016555/8/2014

Consumer Healthcare Products Association Comments on OTC Monograph System

D00001656

TYLNJ 05705414-419

7/12/2014 Guidance for Industry. Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use - Labeling for Products that Contain Acetaminophen

D00001657 No Date Comments on Expert Paul Rever by R. Nelson, Ph.D.

D00001658 No Date FDA -"Acetaminophen - Read the Label"

D00001659 TYLNJ 05380515 No Date Radio Ad - Tylenol Extra Strength

D00001660 TYLNJ 05380540 No Date Radio Ad - Tylenol Arthritis



D00001663 TYLNJ 05380566 No Date Radio Ad - Tylenol Rapid Release Gels

D00001664 TYLNJ 05380567 No Date Radio Ads - Tylenol Arthritis





D00001669 TYLNJ 05380574 No Date Radio Ads - Tylenol Rapid Release Gels (Jimmy Johnson)

D00001670 TYLNJ 05380575 No Date Radio Ad - Tylenol Rapid Release Gels (Elliott Sadler)


D00001672 TYLNJ 05380578 No Date Radio Ad - Tylenol Rapid Release Gels (Jimmy Johnson)

D00001673 TYLNJ 05380579 No Date Radio Ad -Tylenol Rapid Release Gels

D00001674 TYLNJ 05380580 No Date Radio Ad - Tylenol Rapid Release Gels (Dale Earnhardt, Jr.)

D00001675 TYLNJ 05380581 No Date Radio Ad - Tylenol Rapid Release Gels (Dale Earnhardt, Jr.)








D00001682 TYLNJ 05380616 No Date Radio Ad - Rapid Release Gels (Matt Kenseth)





D00001687 TYLNJ 05380640 No Date Radio Ad - Tylenol Arthritis (Drug Interaction)



D00001690 TYLNJ 05380647 No Date Radio Ad - Tylenol Allergy

D00001691 TYLNJ 05380649 No Date Radio Ad -Tylenol Rapid Release Gels (Kevin Harvick)


D00001693 TYLNJ 05380662 No Date Radio Ad - Tylenol is not affected by the store brand acetaminophen products recall

D00001694 TYLNJ 05380673 No Date Radio Ad - Tylenol Rapid Release (Team Tylenol)




D00001698 TYLNJ 05986424 No Date Radio Ad - Tylenol Safest Pain Reliever

D00001699 TYLNJ 05986425 No Date Radio Ad - Tylenol Go Tabs (Chewable)

D00001700 TYLNJ 06014256 No Date Radio Ad -Tylenol and Pepcid AC warning to clean out medicine cabinet and get rid of expired medicine

D00001701 TYLNJ 06014257 No Date Radio Ad - Tylenol is different than nsaid

D00001702 TYLNJ 06014258 No Date Radio Ad - Tylenol is not a nsaid and is different

D00001703 TYLNJ 07315064 No Date Acetaminophen Action Plan Update July 2012

D00001704 TYLNJ 07255849 No Date Acetaminophen Risk Management Marketing Plan

D00001705 TYLNJ 05904193-4194 Undated Dear Healthcare Professional Letter

D00001706 TYLNJ 01942865-892 Undated Narrative Summaries - Study 00-104







































D00001744 Undated Joint Statement

D00001745 TYLNJ 02489281-93 Undated Sandoz Basic Product Document

D00001746 TYLNJ 02487686 Undated Comparison of APAP projects

D00001747 TYLREP00541418 Undated Comparison of APAP projects




D00001751 TYLNJ 02487684-89 Undated Project Protect

D00001752 TYLNJ 03741936-37 Undated Dialog SDI Prints

D00001753 TYLNJ 03741938-44 Undated International Application Published Under the Patent Cooperation Treaty (PCT)

D00001754 TYLNJ 06311339-375 Undated Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report

D00001755

TYLNJ 06311376-484

Undated Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report, Junior Strength Tylenol Fruit Chewable

D00001756

TYLNJ 10644438-46

Undated McNeil Consumer Funded Investigator Initiated Studies: Acetaminophen Publications 2006-August 2012

D00001757TYLNJ 10587332-362

Partners in Self-Care_ Self- Treatment Options for Insomnia (Partnered with APhA) (March 2004-Present)

D00001758TYLNJ 10587600-607

Types of OTC Medicines and How They Work (Partnered with AAFP) (October 2005-Present)


D00001760 UTSMC-00001-207 William Lee Production Documents

D00001761 TYLNJ 07315064 Acetaminophen Action Plan Update July 2012

D00001762 TYLNJ 07255849 Acetaminophen Risk Management Marketing Plan


D00001763 Materials found on the website for Administration on Aging

D00001764 Materials found on the website for Centers for Disease Control

D00001765 Materials found on the website for US Department of Health and Human Services

D00001766 Materials found on the website for American Academy of Allergy Asthma & Immunology

D00001767 Materials found on the website for American Academy of Dermatology

D00001768 Materials found on the website for American Academy of Facial Plastic and Reconstructive Surgery

D00001769 Materials found on the website for American Academy of Family Physicians

D00001770 Materials found on the website for American Academy of Neurology

D00001771 Materials found on the website for American Academy of Orthopaedic Surgeons

D00001772 Materials found on the website for American Academy of Pediatrics

D00001773 Materials found on www.healthychildren.org

D00001774 Materials found on the website for American Academy of Physical Medicine & Rehabilitation

D00001775 Materials found on the website for American Association for Hand Surgery

D00001776 Materials found on the website for American College of Emergency Physicians

D00001777 Materials found on the website for American College of Gastroenterology

D00001778 Materials found on the website for American College of Physicians

D00001779 Materials found on the website for American College of Rheumatology

D00001780 Materials found on the website for American Dental Association

D00001781 Materials found on the website for American Geriatrics Society

D00001782 Materials found on the website for American Heart Association

D00001783 Materials found on the website for American Journal of Cardiology

D00001784 Materials found on the website for American Journal of Kidney Diseases

D00001785 Materials found on the website for American Journal of Therapeutics

D00001786 Materials found on the website for American Pain Society


D00001787 Materials found on the website for American Society for Bariatric Surgery

D00001788 Materials found on the website for American Society of Anesthesiologists

D00001789 Materials found on the website for American Thoracic Society

D00001790 Materials found on the website for Annals of the Rheumatic Diseases

D00001791 Materials found on the website for Cincinnati Children's Hospital Medical Center

D00001792 Materials found on the website for Clinical Pharmacology & Therapeutics

D00001793 Materials found on the website for Current Medical Research and Opinion

D00001794 Materials found on the website for European League Against Rheumatism

D00001795 Materials found on the website for Institute for Clinical Systems Improvement

D00001796 Materials found on the website for International Evidence Based Group for Neonatal Pain

D00001797 Materials found on the website for Massachusetts Medical Society

D00001798 Materials found on the website for Medical Society of the State of New York

D00001799 Materials found on the website for National Digestive Diseases Information Clearinghouse

D00001800 Materials found on the website for National Headache Foundation

D00001801 Materials found on the website for National Heart, Lung and Blood Institute

D00001802 Materials found on the website for National Institute of Diabetes and Digestive and Kidney Diseases

D00001803 Materials found on the website for National Kidney Foundation

D00001804 Materials found on the website for North American Spine Society

D00001805 Materials found on the website for Osteoarthritis Research Society International

D00001806 Materials found on the website for World Health Organization

D00001807 Materials found on the website www.uptodate.com

D00001808 FDA, CFR, Format for OTC Labels Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.66

D00001809 FDA History III Available at: http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm055118.htm


D00001810 FDA, 21 CFR part 330 (a4 (v)--Over-the-counter (otc) human drugs which are generally recognized as safe and effective and not misbranded http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm Accessed May 15

D00001811 FTC Policy Statement on Deception, May 1983, available at: http://www.ftc.gov/ftc-policy-statement-on-deception

D00001812 Public Relations Society of America (PRSA) Member Code of Ethics. Available at: http://www.prsa.org/aboutprsa/ethics/codeenglish/#.U3T3QqZOXA8

D00001813 California Biomedical Research Association. Fact Sheet. New Drug Development Process. Available at: http://ca-biomed.org/pdf/media-kit/fact-sheets/cbradrugdevelop.pdf.

D00001814 Handler, M. The control of false advertising under the Wheeler Lea act, Available at: http://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=1940&context=lcp

D00001815 Herper, M., The Truly Staggering Cost Of Inventing New Drugs. Forbes Magazine, 2012 Available at: http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs. Accessed May 15

D00001816 00/00/1998 Amerge labelD00001817 00/00/2007 Amerge labelD00001818 00/00/2007 Amlodipine Besylate (Norvasc) labelD00001819 00/00/2010 Amlodipine Besylate (Norvasc) labelD00001820 00/00/2011 Amlodipine Besylate (Norvasc) labelD00001821 00/00/2013 Amlodipine Besylate (Norvasc) labelD00001822 00/00/1999 Amoxil labelD00001823 00/00/2001 Amoxil labelD00001824 00/00/2003 Amoxil labelD00001825 00/00/2005 Amoxil labelD00001826 00/00/2007 Amoxil labelD00001827 00/00/2008 Amoxil labelD00001828 00/00/1997 Atarax (hydroxyzine) labelD00001829 00/00/2004 Augmentin (Amox/Clav ES 600mg) labelD00001830 00/00/2013 Avinza (Morphine sulfate) labelD00001831 00/00/2007 Azithromycin (Z-pak 250mg) labelD00001832 00/00/2013 Bactrim (Sulfamethoxazole and Trimethoprim) labelD00001833 00/00/2007 Bactrim DS labelD00001834 00/00/2012 Bactrim DS labelD00001835 00/00/2013 Benadryl labelD00001836 00/00/2011 Cardene (Nicardipine HCL) labelD00001837 00/00/2010 Celexa (Citalopram) label


D00001838 00/00/2009 Cellcept (Mycophenolate mofetil) labelD00001839 00/00/2013 Cellcept (Mycophenolate mofetil) labelD00001840 00/00/2009 Cipro labelD00001841 00/00/2009 Clindamycin (Cleocin) labelD00001842 00/00/1995 Deltasone aka Prednisone labelD00001843 00/00/2008 Difulcan (fluconazole) labelD00001844 00/00/2013 Difulcan (fluconazole) labelD00001845 00/00/2014 Difulcan (fluconazole) labelD00001846 00/00/2009 Extra Strength Tylenol EZ Tabs Bottle labelD00001847 00/00/2010 Flagyl (metronidazole) labelD00001848 00/00/2013 Flagyl (metronidazole) labelD00001849 00/00/2010 Furosemide (Lasix) labelD00001850 00/00/2012 Glucagon labelD00001851 00/00/2011 Haldol (Haloperidol) labelD00001852 00/00/2013 Hecoria (Tacrolimus capsules) labelD00001853 00/00/2013 Humalog (Insulin lispro) labelD00001854 00/00/2006 Hydrocodone/APAP 5mg/500mg (aka Vicodin) labelD00001855 00/00/2006 Keflex (Cephalexin) labelD00001856 00/00/2005 Keppra (Levetiracetam) labelD00001857 00/00/2013 Keppra (Levetiracetam) labelD00001858 00/00/2014 Keppra (Levetiracetam) labelD00001859 00/00/2012 Lantus insulin labelD00001860 00/00/2012 Lasix (furosemide) labelD00001861 00/00/2013 Levaquin (Levofloxacin) labelD00001862 00/00/2014 Levaquin (Levofloxacin) labelD00001863 00/00/1997 Levsin labelD00001864 00/00/2013 Lovenox (Enoxaparin) labelD00001865 00/00/2005 Maxalt MLT labelD00001866 00/00/2013 Mefoxin (Cefoxitin) labelD00001867 00/00/2013 Methadone (Methadone HCL) labelD00001868 00/00/2003 Miralax (Polyethylene Glycol) labelD00001869 00/00/2010 Nexicolon (Clonodine) labelD00001870 00/00/2008 Novolog Insulin labelD00001871 00/00/2005 Nubain labelD00001872 00/00/1998 Nystatin labelD00001873 00/00/2006 Oxycodone/APAP 5mg/325mg (aka Percocet) labelD00001874 00/00/2013 Oxycontin (Oxycodone HCL) labelD00001875 00/00/2013 Pepcid (Famotidine) labelD00001876 00/00/2005 Phenergan labelD00001877 00/00/2002 Prednisone (Roxane) labelD00001878 00/00/2012 Prednisone (Roxane) labelD00001879 00/00/2007 Prempro (Medroxyprogesterone) labelD00001880 00/00/2012 Prevacid (Lansoprazole) labelD00001881 00/00/2009 Prograf (Tacrolimus) labelD00001882 00/00/2010 Prograf (Tacrolimus) labelD00001883 00/00/2011 Prograf (Tacrolimus) labelD00001884 00/00/2011 Prozac (Fluoxetine) label


D00001885 00/00/1997 Pyridium (phenazopydirine) labelD00001886 00/00/1997 Questran labelD00001887 00/00/2013 Risperdal (Risperidone) labelD00001888 00/00/2009 Risperidone labelD00001889 00/00/2011 Simvastatin (Zocor) labelD00001890 00/00/2009 Tacrolimus labelD00001891 00/00/1997 Thorazine (chlorpromazine) labelD00001892 00/00/2013 Toradol (Ketorolac Tromethamine) labelD00001893 00/00/2005 Toradol labelD00001894 00/00/2013 TriNessa-28 labelD00001895 00/00/2005 Tylenol (acetaminophen) labelD00001896 00/00/2011 Tylenol (acetaminophen) labelD00001897 00/00/2013 Tylenol (acetaminophen) labelD00001898 00/00/2009 Ultram (Tramadol) labelD00001899 00/00/2009 Ursodiol and Urso Forte labelD00001900 00/00/2013 Ursodiol and Urso Forte labelD00001901 00/00/2010 Valcyte (Valganciclovir HCL) labelD00001902 00/00/2013 Valcyte (Valganciclovir HCL) labelD00001903 00/00/2005 Valtrex labelD00001904 00/00/2012 Valtrex labelD00001905 00/00/1997 Versed labelD00001906 00/00/1997 Vicodin labelD00001907 00/00/2013 Vicodin labelD00001908 00/00/2014 Visatril labelD00001909 00/00/1994 Wygesic labelD00001910 00/00/2011 Zantac labelD00001911 00/00/2013 Zantac labelD00001912 00/00/2005 ZenapaxD00001913 00/00/2010 ZithromaxD00001914 00/00/2012 ZofranD00001915 00/00/2013 ZofranD00001916 00/00/2013 ZosynD00001917 00/00/2009 ZoviraxD00001918 00/00/2013 ZoviraxD00001919 TYLNJ 09221206 9/1/2005 Tylenol Sore Throat Daytime Non-Drowsy with instant Cool

Burst Sensation Label

D00001920 TYLNJ 09221340 11/9/2005 Tylenol Sore Throat Label

D00001921 TYLNJ 09220941 4/19/2007 Tylenol Sinus Congestion & Pain – Daytime Non-Drowsy Cool Burst Caplets Label Dated 2/18/2004

D00001922 TYLNJ 09218497 4/19/2007 Tylenol Sinus Congestion & Pain – Daytime Non-Drowsy Cool Burst Caplets Label Dated 2/18/2004

D00001923 TYLNJ 09223848-51 4/26/2007 Tylenol Allergy Multi-Symptom Cool Burst Caplets Label Dated 2/18/2004

D00001924 TYLNJ 09223847 4/26/2007 Tylenol Allergy Multi-Symptom Cool Burst Caplets Label Dated 2/18/2004


D00001925 TYLNJ 09218252 7/18/2007 Tylenol Cold Severe Congestion with Instant Cool Burst Sensation Daytime Non-Drowsy Caplets Label Dated 3/22/2006

D00001926 TYLNJ 09217342 7/18/2007 Tylenol Sinus Severe Congestion –Daytime Non-Drowsy Cool Blast Caplets Label Dated 3/22/2006

D00001927 TYLNJ 09217298 7/18/2007 Tylenol Sinus Severe Congestion –Daytime Non-Drowsy Cool Blast Caplets Label Dated 3/22/2006

D00001928 TYLNJ 06013591-624 9/13/2007 Infants Tylenol Suspension Drops (Cherry Flavor) NDC 143 UPC 186 Drug Product Listing & labels

D00001929 TYLNJ 06013591-624 9/13/2007 Infants Tylenol Suspension Drops (Cherry Flavor) NDC 143 UPC 186 Drug Product Listing & labels

D00001930 TYLNJ 09218605 12/12/2007 Tylenol Allergy Multi-Symptom Nighttime Cool Burst Caplets Label Dated 10/2/2007

D00001931 TYLNJ 09221339 2/26/2008 Tylenol Warming Cough & Severe Congestion Honey & Lemon Daytime 8 oz Liquid Label Dated 11/21/2003

D00001932 TYLNJ 09221255-58 2/26/2008 Tylenol Warming Cough & Severe Congestion Honey & Lemon Daytime 8 oz Liquid Label Dated 11/21/2003

D00001933 TYLNJ 09219840 3/29/2008 Tylenol Warming Cough & Severe Congestion Daytime 9 Bake Booklet Dated 1/12/2004

D00001934 TYLNJ 09219840 3/29/2008 Tylenol Warming Cough & Severe Congestion Daytime 9 Bake Booklet Dated 1/12/2004

D00001935 4/17/2008 Benadryl-D Allergy & Sinus Ultratab Tables Family Code# 225 Formula# C-1146-3 DC# 50580-225-XX Drug Facts

D00001936 TYLNJ 09222654 7/17/2008 Children’s Tylenol Plus Cough & Sore Throat Cherry Label Dated 07/27/1987

D00001937 TYLNJ 09223600 7/17/2008 Children’s Tylenol Plus Flu Bubble Gum Dated 07/27/1987

D00001938 TYLNJ 09217506 3/12/2009 Tylenol Arthritis Pain Extended Release 650 mg caplets label Dated 12/7/1989

D00001939 TYLNJ 09219144 6/23/2009 Tylenol Arthritis Pain Extended Release Geltabs Label Dated 09/03/1987

D00001940 TYLNJ 09218565 6/24/2009 Tylenol Arthritis Pain 650 Mg Caplets Label Dated 12/1/2003

D00001941 TYLNJ 06014139-52 9/1/2009 Concentrated Tylenol Infants’ Drops – Dye Free Cherry Dated 11/03/1998

D00001942 TYLNJ 06014139-152 9/22/2009 Concentrated Tylenol Infants’ Drops Grape Dated 08/13/1999

D00001943 TYLNJ 09223349 10/4/2009 Tylenol Extra Strength Easy to Swallow EZ Tabs Label Dated 07/12/2007

D00001944 TYLNJ 09219118 10/7/2009 Tylenol Arthritis Pain Gelcaps Label Dated 11/7/2008

D00001945 TYLNJ 06014223–55 11/6/2009 Tylenol Extra Strength Crushable/Dye Free Tablets Label Dated 12/12/2006

D00001946 TYLNJ 09220007 1/5/2010 Extra Strength Tylenol PM Caplets Label Dated 07/12/2007

D00001947 TYLNJ 06013707-39 1/5/2010 Extra Strength Tylenol PM Geltabs Label Dated 12/12/2006


D00001948 TYLNJ 09217596 1/21/2010 Tylenol PM Rapid Release Gels Dated 07/12/2007

D00001949 TYLNJ 09217728 1/21/2010 Tylenol PM Rapid Release Gels Label Dated 07/12/2007

D00001950 TYLNJ 09223535-39 2/3/2010 Children’s Tylenol Oral Suspension Bubblegum Yum Dated 07/27/1987

D00001951 TYLNJ 09220105 2/3/2010 Children’s Tylenol Oral Suspension Grape Splash Label Dated 07/27/1987

D00001952 TYLNJ 09220066 2/9/2010 Children’s Tylenol Oral Suspension very berry strawberry label Dated 07/27/1987

D00001953 TYLNJ 09220232 2/9/2010 Tylenol Cold Severe Multi-Symptom Cool Burst Liquid Label Dated 11/21/2003

D00001954 TYLNJ 09222383 2/16/2010 Children’s Tylenol Plus Multi-Symptom Cold Grape Dated 07/27/1987

D00001955 TYLNJ 09223592 2/17/2010 Children’s Tylenol Plus Multi-Symptom Cold Dye-Free Grape Dated 07/27/1987

D00001956 TYLNJ 09221377-78 2/19/2010 Tylenol Sinus Congestion & Pain Nighttime Rapid Release Gels Label Dated 05/04/2009

D00001957 TYLNJ 09220843 2/22/2010 Tylenol Severe Cold & Flu Warming Honey Lemon Label Dated 11/21/2003

D00001958 TYLNJ 09220713 2/22/2010 Tylenol Severe Cold & Flu Warming Label

D00001959 TYLNJ 09218553 2/23/2010 Tylenol Severe Sinus Congestion & Pain Cool Burst Caplets Label Dated 10/02/2007

D00001960 TYLNJ 06013974-80 2/25/2010 Extra Strength Tylenol Cold & Cough Daytime Non-Drowsy Cool Burst Label

D00001961 TYLNJ 09218691 3/1/2010 Children’s Tylenol Plus Cold & Allergy Bubble Gum

D00001962 TYLNJ 09219776 3/2/2010 Tylenol-D Sinus Severe Congestion Cool Burst Caplets Label Dated 02/18/2004

D00001963 TYLNJ 09222451 3/3/2010 Tylenol Cold Multi-Symptom Daytime Non-Drowsy Rapid Release Gels Dated 02/18/2004

D00001964 TYLNJ 09217295 3/4/2010 Tylenol Cold Severe Head Congestion Cool Burst Caplets label Dated 10/2/2007

D00001965 TYLNJ 09219102 3/4/2010 Tylenol Cold Severe Head Congestion Cool Burst Caplets label Dated 10/2/2007

D00001966 TYLNJ 09220436 3/8/2010 Tylenol Sinus & Allergy Cool Burst Caplets Dated 02/18/2004

D00001967 TYLNJ 09222889 3/9/2010 Tylenol Sinus Congestion & Pain Rapid Release Daytime Non-Drowsy Gels Label Dated 02/18/2004

D00001968 TYLNJ 09222514 3/14/2010 Tylenol Cold Multi-Symptom Daytime Non-Drowsy Citrus Burst Label

D00001969 TYLNJ 09222515 3/14/2010 Tylenol Cold Multi-Symptom Daytime Non-Drowsy Citrus Burst Label

D00001970 TYLNJ 09220339 3/18/2010 Tylenol Severe Sinus & Allergy Cool Burst Caplets Label Dated 10/2/2007

D00001971 TYLNJ 09218901 3/18/2010 Tylenol Sinus & Allergy Severe Cool Burst Caplets Dated 10/2/2007

D00001972 TYLNJ 09220491 4/7/2010 Tylenol Sinus & Allergy Rapid Release Gels Label Dated 02/18/2004


D00001973 TYLNJ 09223377-81 4/13/2010 Tylenol Cold Mucus Clear Rapid Release Gels Dated 12/10/2009

D00001974 TYLNJ 09219009 4/16/2010 Tylenol Cold Severe Multi-Symptom Dated 01/12/2004

D00001975 TYLNJ 09221201 4/19/2010 Extra Strength Tylenol Cold Sore Throat Cool Burst Dated 11/21/2003

D00001976 TYLNJ 09219814 4/19/2010 Tylenol-D Cold & Flu Severe Cool Burst Caplets Label Dated 02/18/2004

D00001977 TYLNJ 09223434-38 5/3/2010 Tylenol Cold Mucus Clear Rapid Release Gels Dated 01/08/1990

D00001978 TYLNJ 09224234 6/11/2010 Tylenol 8 HR Label Dated 05/18/1992

D00001979 TYLNJ 09218593 6/21/2010 Tylenol Arthritis Pain 650 Mg Caplets Extended Release Label Dated 11/7/2008

D00001980 TYLNJ 06013974-80 6/25/2010 Extra Strength Tylenol Cold Cough & Daytime Dated 01/12/2004

D00001981 TYLNJ 09223347-48 7/20/2010 Tylenol PM Extra Strength Geltabs Label Dated 01/08/2010

D00001982 TYLNJ 09219120 7/28/2010 Tylenol Arthritis Pain Gelcaps Label Dated 11/7/2008

D00001983 TYLNJ 06013545-60 8/2/2010 Extra Strength Tylenol PM Caplets Label Dated 01/08/2010

D00001984 TYLNJ 09224366 8/5/2010 Tylenol PM Rapid Release Gels Label Dated 01/08/2010

D00001985 TYLNJ 06013545-60 8/9/2010 Extra Strength Tylenol PM Caplets Label Dated 01/08/2010

D00001986 TYLNJ 09220154 9/24/2010 Children’s Tylenol Oral Suspension Grape Splash Label

D00001987 TYLN J09223635-38 11/1/2010 Children’s Tylenol Dye Free Cherry Blast Label

D00001988 TYLNJ 09220403 2/7/2011 Tylenol Cold Multi-Symptom Coolburst Nighttime Liquid – label Dated 11/21/2003

D00001989 TYLNJ 09220337 2/7/2011 Tylenol Severe Cold Multi-Symptom Cool Burst Label

D00001990 TYLNJ 09220385 2/7/2011 Tylenol Severe Cold Multi-Symptom Cool Burst Liquid Label

D00001991 TYLNJ 09222803 3/5/2011 Children’s Tylenol Oral Suspension-Grape

D00001992 TYLNJ 09218254 3/15/2011 Tylenol Cold Multi-Symptom Daytime Dated 01/12/2004

D00001993 TYLNJ 09220312 3/15/2011 Tylenol Severe Cold Multi-Symptom Label Dated 1/12/2004

D00001994 TYLNJ 09222516 3/23/2011 Tylenol Cold Multi-Symptom Daytime Non-drowsy Citrus Burst

D00001995 TYLNJ 09218299 4/4/2011 Tylenol Cold Multi-Symptom Coolburst Nighttime Liquid – label

D00001996 TYLNJ 09223382-83 4/4/2011 Tylenol Severe Cold Multi-Symptom Cool Burst Label

D00001997 TYLNJ 09217056 4/7/2011 Jr. Strength Tylenol Grape Meltaways Family Code Number 514 Formula# C-1015-1 NDC# 50580-514-XX Drug Facts

D00001998 TYLNJ 09223287-88 4/7/2011 Jr. Tylenol Bubblegum Burst Meltaways Family Code Number: 513 Formula # C-1016-1 NDC # 50580-513-XX Drug Facts


D00001999 TYLNJ 09221152 4/12/2011 Children’s Tylenol Oral Suspension Grape Splash & Signature Page re: Principle Display Panel (PDP) for Tylenols Suspension

D00002000 TYLNJ 06014153-61 4/13/2011 Tylenol Severe Cold & Flu Caplets – Label Dated 11/17/2010

D00002001 TYLNJ 09218828 4/14/2011 Children’s Tylenol Oral Suspension (Dye-Free Cherry) Family Code #166 Formula # C-1028-1 (FW); C-1028-4 (Beerse, Belgium) NDC# 50580-166-XX Drug Facts

D00002002 TYLNJ 09217213 6/1/2011 Infants’ Tylenol Grape Flavor Oral Suspension 160 mg per 5 ml - SimpleMeasure Label

D00002003 TYLNJ 09223522 6/8/2011 Children’s Tylenol Meltaways ages 2-6 Label Dated 08/26/1987

D00002004 TYLNJ 09218692 6/10/2011 Children’s Tylenol Pain & Fever Ages 2-11 Cherry Blast Label

D00002005 TYLNJ 09224185-89 6/17/2011 Tylenol Extra Strength for adults caplets Dated 06/04/2010

D00002006 TYLNJ 09223311-14 7/22/2011 Jr. Tylenol Meltaways Grape Punch – Label Dated 1/28/1998

D00002007 TYLNJ 09222902 7/28/2011 Tylenol Sinus Congestion & Pain Caplets (daytime) NDC Family Code: 275 Formula #C-1080-3, C-1080-4 and C-1080-6 NDC# 50580-275-XX Drug Facts

D00002008 TYLNJ 09217668 7/29/2011 Tylenol Regular Strength Caplets NDC Family Coe: 501 Formula # C-162-12 NDC# 50580-501-XX; 50580-502-XX Drug Facts

D00002009 TYLNJ 06013860-68 8/2/2011 Tylenol Extra Strength Rapid Release Gels Dated 12/12/2006

D00002010 TYLNJ 09217828-29 8/17/2011 Infants’ Tylenol Cherry SimpleMeasure 160 mg per 5ml Label

D00002011 TYLNJ 09218002 10/4/2011 Tylenol Severe Sinus Congestion & Pain Daytime Non-Drowsy Dated 05/24/2011

D00002012 TYLNJ 09221827-28 10/27/2011 Tylenol Extra Strength Caplets label

D00002013 TYLNJ 09217652 11/17/2011 Tylenol PM Geltabs Label Dated 1/08/2012

D00002014 TYLNJ 09219219 1/16/2012 Tylenol Cold Head Congestion Severe Caplets NDC Family Code: 566 Formula# C-1072-4 NDC#50580-566-XX Drug Facts

D00002015 TYLNJ 09223744-48 1/16/2012 Tylenol Cold Head Congestion Severe Caplets NDC Family Code: 566 Formula # C-1072-4 NDC# 50580-566-XX Drug Facts

D00002016 TYLNJ 09223052 1/26/2012 Tylenol Regular Strength Caplets Label Dated 09/19/01

D00002017 TYLNJ 09219862-63 3/15/2012 Children’s Tylenol Oral Suspension Grape Splash Label

D00002018 TYLNJ 09222513 3/30/2012 Tylenol Cold Multi-Symptom Daytime Non-Drowsy Labels & Signature Page re: Artwork for Tylenol Caplets

D00002019 TYLNJ 09222902 3/30/2012 Tylenol Sinus Congestion & Pain Daytime Non-Drowsy caplets Label & Signature Page re: Artwork for Tylenol Caplets


D00002020 TYLNJ 09220682 4/3/2012 Tylenol Severe Cold Head Congestion Caplets Label & Signature page re: Artwork for Tylenol Caplet Dated 11/16/2011

D00002021 TYLNJ 09222018 4/19/2012 Tylenol Extra Strength Tablet Family Code # 499 Formula # C-10-52 NDC # 50580-499-XX Drug Facts

D00002022 TYLNJ 09222969 5/14/2012 Tylenol Regular Strength Tables NDC Family Code: 496 Formula # C-2-91 NDC# 50580-496-XX Drug facts

D00002023 TYLNJ 09222833-38 5/23/2012 Tylenol Regular Strength Tablets Dated 5/18/1992

D00002024 TYLNJ 09223091-92 6/1/2012 Jr. Tylenol Meltaways – acetaminophen tablet, chewable Drug facts

D00002025 TYLNJ 09223238 6/18/2012 Jr. Tylenol Meltaways Drug Facts

D00002026 TYLNJ 09222317 Concentrated Tylenol Infants Drops - Dye Free -Cherry Flavor

D00002027 TYLNJ 09223113 7/24/2012 Jr. Tylenol Meltaways Drug Facts

D00002028 TYLNJ 09217099 8/1/2012 Infants’ Tylenol Grape Flavor Oral Suspension 160 mg per 5 ml - SimpleMeasure Label & Signature Page re: Artwork for Tylenol Suspension Drop

D00002029 TYLNJ 09219115 11/23/2012 Tylenol Extra Strength Caplets Dated 09/19/2001 & Signature Page re: Artwork for Tylenol Caplet

D00002030 TYLNJ 09219116 11/26/2012 Tylenol Extra Strength Caplets Label Dated 12/12/2005 & Signature Page re: Artwork or Thermal for Tylenol Caplet

D00002031 TYLNJ 09219356 12/10/2012 Tylenol Severe Cold & Flu Warming For Adults Dated 03/18/2012

D00002032 TYLNJ 09219456 12/10/2012 Tylenol Severe Cold & Flu Warming Honey & Lemon Dated 03/18/2012

D00002033 TYLNJ 09223385 12/10/2012 Tylenol Severe Cold Multi-Symptom Dated 03/18/2012

D00002034 TYLNJ 09217869 12/18/2012 Infants’ Tylenol Cherry Flavor SimpleMeasure 160mg per 5ml label & Signature Page re: Artwork for Tylenol Suspension Drop

D00002035 TYLNJ 09217837 12/18/2012 Infants’ Tylenol Cherry Flavor SimpleMeasure 160mg per 5ml label & Signature Page re: Artwork for Tylenol Suspension Drop

D00002036 TYLNJ 09218233 1/8/2013 Tylenol Cold Multi-Symptom Nighttime for Adults Liquid – Labels Dated 3/18/2012

D00002037 TYLNJ 09218373 2/20/2013 Tylenol Cold Multi-Symptom Nighttime for Adults Liquid – Labels

D00002038 TYLNJ 09220792 2/20/2013 Tylenol Severe Cold & Flu Warming Honey Lemon Label

D00002039 TYLNJ 09220735 2/20/2013 Tylenol Severe Cold & Flu Warming Label

D00002040 TYLNJ 09220302 2/25/2013 Tylenol Severe Cold Multi-Symptom Label

D00002041 TYLNJ 09221199 2/27/2013 Extra Strength Tylenol Cold Sore Throat Cold Burst Label

D00002042 TYLNJ 09221101 2/27/2013 Extra Strength Tylenol Cold Sore Throat Label

D00002043 TYLNJ 09222446 3/7/2013 Tylenol Cold Multi-Symptom Daytime for adults Label Dated 3/18/2012


D00002044 4/00/2013 WHO Model List of Essential Medicines; www.who.int/medicines/publications/essentialmedicines/en/index.html

D00002045 TYLNJ 09218253 4/19/2013 Tylenol Cold Multi-Symptom Daytime for Adults

D00002046 TYLNJ 09223284 8/3/2013 Label Batch DBL3W of 24.02.2013 Exp. Date 24.08.2013 Product Tylenol Sinus Sev 325 Mg Cpl. BU JJC – US (2)

D00002047 TYLNJ 09218823 Drug Listings –History Family Code 318-Children’s Suspension--Canada

D00002048 TYLNJ 09224010-17 9/30/2013 Email from Scott Monks to Cheryl Sioklia re: Tylenol 8 Hour Caplet NDC 297 – Confirmation no longer being made

D00002049 TYLNJ 09223966 10/1/2013 Email from Luke Mason to Cheryl Sikolia re: Tylenol Sinus Congestion & Pain NDC 262 and Tylenol Cold Cough and Severe Congestion NDC 349 – confirmation of exp dates

D00002050 TYLNJ 09223749-57 10/28/2013 Email from Scott Monks to Cheryl Sikolia re Extra Strength Tylenol-NDC 1176, 244 and 422 – Confirmation no longer being made

D00002051 TYLNJ 09223682-83 9/27/2013 Email from Luke Mason to Scott Monks re: Benadryl Tablets NDC 225

D00002052 TYLNJ 09219319 12/16/2013 Tylenol Cold Cough & Severe Congestion Drug Facts

D00002053 TYLNJ 09223352 12/16/2013 Tylenol Extra Strength Drug Facts

D00002054 TYLNJ 09222998 12/16/2013 Tylenol Regular Strength Drug Facts

D00002055 TYLNJ 09224292 12/17/2013 Tylenol 8HR Drug Facts

D00002056 12/24/2013 Children’s Tylenol Drug Facts

D00002057 TYLNJ 09224362-65 Unknown Children’s Tylenol Dye-Free Cherry Blast Label

D00002058 TYLNJ 09223515 Unknown Children’s Tylenol Meltaways (Wacky Watermelon) NDC#516 UPC#516 Drug Product Listing & Labels

D00002059 TYLNJ 06014179-181 Unknown Children’s Tylenol Meltaways bubblegum burst label

D00002060 TYLNJ 09222591 Unknown Children’s Tylenol Meltaways Grape Punch Flavor Ages 2-6

D00002061 TYLNJ 09224361 Unknown Children’s Tylenol Oral Suspension – Grape Label

D00002062 TYLNJ 09223130 Unknown Children’s Tylenol Oral Suspension – Grape Label

D00002063 TYLNJ 09218868 Unknown Children’s Tylenol Oral Suspension (Dye-Free Cherry) Family Code #166 Formula # C-1028-1 (FW); C-1028-4 (Beerse, Belgium) NDC# 50580-166-XX Drug Facts

D00002064 TYLNJ 09223529-34 Unknown Children’s Tylenol Oral Suspension Grape Label

D00002065 TYLNJ 09218817 Unknown Children’s Tylenol Oral Suspension Grape Splash label

D00002066 TYLNJ 09220209 Unknown Children’s Tylenol Oral Suspension Grape Splash Label

D00002067 TYLNJ 09220086 Unknown Children’s Tylenol Oral Suspension Grape Splash Label

D00002068 TYLNJ 09220020 Unknown Children’s Tylenol Oral Suspension very berry strawberry label

D00002069 TYLNJ 09222802 Unknown Children’s Tylenol Oral Suspension-Grape

D00002070 TYLNJ 09218054 Unknown Children’s Tylenol Plus Cough & Sore throat Cherry Label

D00002071 TYLNJ 09222211 Unknown Children’s Tylenol Plus Multi-Symptom Cold Grape


D00002072 TYLNJ 09219876 Unknown Children’s Tylenol Suspension (Bubble Gum) NDC#407 UPC#407 Drug Product Listing & labels

D00002073 TYLNJ 09219869 Unknown Children’s Tylenol Suspension (Bubble Gum) NDC#407 UPC#407 Drug Product Listing & labels

D00002074 TYLNJ 06013842-59 Unknown Children’s Tylenol Suspension (Dyefree Cherry) NDC#166 UPC#166 Drug Product Listing & labels

D00002075 TYLNJ 06013842-59 Unknown Children’s Tylenol Suspension (Dyefree Cherry) NDC#166 UPC#166 Drug Product Listing & labels

D00002076 TYLNJ 06013625-31 Unknown Children’s Tylenol Suspension Liquid (Grape) Family Code Number: 318 Formula #C-1307-1 NDC#50580-318-XX Drug Facts

D00002077 TYLNJ 06013625-31 Unknown Children’s Tylenol Suspension Liquid (Grape) NDC#50580-318-XX Drug Facts Label

D00002078 TYLNJ 09218824-27 Unknown Children’s Tylenol Suspension Very Berry Strawberry NDC#493 UPC#493 Drug Product Listing & Labels

D00002079 TYLNJ 09218712-15 Unknown Children’s Tylenol Suspension Very Berry Strawberry NDC#493 UPC#493 Drug Product Listing & Labels

D00002080 TYLNJ 09224064-67 Unknown Extra Strength Tylenol Adult Liquid (Cherry) NDC#111 UPC#500 Drug Product Listing & labels

D00002081 TYLNJ 09223852-59 Unknown Extra Strength Tylenol Adult Liquid (Cherry) NDC#111 UPC#500 Drug Product Listing & labels

D00002082 TYLNJ 06013373-82 Unknown Extra Strength Tylenol Caplets & Tylenol Rapid Release Gelcaps NDC#444 UPC#444 Drug Product Listing & Labels

D00002083 TYLNJ 06013373-82 Unknown Extra Strength Tylenol Caplets & Tylenol Rapid Release Gelcaps NDC#444 UPC#444 Drug Product Listing & Labels

D00002084 TYLNJ 09221086 Unknown Extra Strength Tylenol EZ Tabs Tablets NDC#422 UPC#422 Drug Product Listing & Labels

D00002085 TYLNJ 09221102 Unknown Extra Strength Tylenol EZ Tabs Tablets NDC#422 UPC#422 Drug Product Listing & Labels

D00002086 TYLNJ 06013869-919 Unknown Extra Strength Tylenol Geltabs NDC#124 UPC#124 Drug Product Listing & labels

D00002087 TYLNJ 06013869-919 Unknown Extra Strength Tylenol Geltabs NDC#124 UPC#124 Drug Product Listing & labels

D00002088 TYLNJ 09220016 Unknown Extra Strength Tylenol PM Caplets Label

D00002089 TYLNJ 09220001 Unknown Extra Strength Tylenol PM Caplets Label

D00002090 TYLNJ 09219993 Unknown Extra Strength Tylenol PM Gelcaps NDC#182 UPC#182 Drug Product Listing & labels

D00002091 TYLNJ 09219927 Unknown Extra Strength Tylenol PM Gelcaps NDC#182 UPC#182 Drug Product Listing & labels

D00002092 TYLNJ 06013707-39 Unknown Extra Strength Tylenol PM Geltabs Label

D00002093 TYLNJ 09217594 Unknown Extra Strength Tylenol PM Liquid (Golden Vanilla) NDC#427 UPC#427 Drug Product Listing & Labels

D00002094 TYLNJ 09217591 Unknown Extra Strength Tylenol PM Liquid (Golden Vanilla) NDC#427 UPC#427 Drug Product Listing & Labels


D00002095 TYLNJ 06013940-73 Unknown Extra Strength Tylenol PM Vanilla Caplets #426 Drug Product Listing & Labels

D00002096 TYLNJ 06013940-73 Unknown Extra Strength Tylenol PM Vanilla Caplets #426 Drug Product Listing & Labels

D00002097 TYLNJ 06013920-39 Unknown Extra Strength Tylenol Tablets NDC#499 UPC# 499 Drug Product Listing & Labels

D00002098 TYLNJ 06013920-39 Unknown Extra Strength Tylenol Tablets NDC#499 UPC# 499 Drug Product Listing & Labels

D00002099 TYLNJ 06014162-70 Unknown Family Code Number: 318 NDC # 50580-318-XX Drug Facts Label

D00002100 TYLNJ 06014162-170 Unknown Infant’s Tylenol Concentrated Drops (Grape Flavor) NDC#144 UPC#122 Drug Product Listing & labels

D00002101 TYLNJ 09218677 - 78 Unknown Infant’s Tylenol Concentrated Drops (Grape Flavor) NDC#144 UPC#122 Drug Product Listing & labels

D00002102 TYLNJ 06013561-90 Unknown Infants’ Tylenol Cherry Flavor SimpleMeasure 160 mg per 5ml Label

D00002103 TYLNJ 06013561-90 Unknown Infants’ Tylenol Cherry Flavor SimpleMeasure 160 mg per 5ml label

D00002104 TYLNJ 09217887 Unknown Infants’ Tylenol Cherry Flavor SimpleMeasure 160mg per 5 ml label

D00002105 TYLNJ 09217879-80 Unknown Infants’ Tylenol Cherry SimpleMeasure 160 mg per 5ml Label

D00002106 TYLNJ 09217769 Unknown Infants’ Tylenol Grape Flavor Oral Suspension 160 mg per 5 ml - SimpleMeasure Label





D00002111 TYLNJ 09217045-46 Unknown Jr. Strength Tylenol Grape Meltaways Family Code # 514 NDC# 50580-514-XX Drug Facts

D00002112 TYLNJ 09223305-10 Unknown Jr. Tylenol Bubblegum Burst Meltaways Family Code Number: 513 NDC # 50580-513-XX Drug Facts

D00002113 TYLNJ 09223114-19 Unknown Jr. Tylenol Meltaways Ages 6-11 Bubblegum Burst Label

D00002114 TYLNJ 09223239-43 Unknown Jr. Tylenol Meltaways Ages 6-11 Grape Punch Label

D00002115 TYLNJ 09223153 Unknown Jr. Tylenol Meltaways Bubblegum Burst Ages 6-11 Label

D00002116 TYLNJ 09223160-63 Unknown Jr. Tylenol Meltaways Grape Punch - Label

D00002117 TYLNJ 09223286 Unknown Jr. Tylenol Meltaways Grape Punch Label

D00002118 TYLNJ 09223811 Unknown Tylenol 8HR Label

D00002119 TYLNJ 09221767 Unknown Tylenol Allergy Multi-Symptom Nighttime Cool Burst Caplets Label


D00002120 TYLNJ 09221767 Unknown Tylenol Allergy Multi-Symptom Nighttime Cool Burst Caplets Label

D00002121 TYLNJ 09217522 Unknown Tylenol Arthritis Pain 650mg Caplets Extended Release Label



D00002124 TYLNJ 09217472 Unknown Tylenol Arthritis Pain Extended Release 650 mg caplets label

D00002125 TYLNJ 09217472 Unknown Tylenol Arthritis Pain Extended Release Geltabs Label

D00002126 TYLNJ 09217424 Unknown Tylenol Arthritis Pain Extended Release Geltabs Label

D00002127 TYLNJ 09220994 Unknown Tylenol Arthritis Pain Gelcaps Label







D00002134 TYLNJ 09338934 Unknown Tylenol Arthritis Pain Geltabs NDC#292 UPC#292 NDA#19-872 Drug Product Listing & labels

D00002135 TYLNJ 09338933 Unknown Tylenol Arthritis Pain Geltabs NDC#292 UPC#292 NDA#19-872 Drug Product Listing & labels

D00002136 TYLNJ 06013805-18 Unknown Tylenol Cold & Flu Severe Caplets label

D00002137 TYLNJ 06013805-18 Unknown Tylenol Cold & Flu Severe for Adults Label

D00002138 TYLNJ 09220401 Unknown Tylenol Cold Multi-Symptom Cool Burst Nighttime liquid for Adults

D00002139 TYLNJ 09222124-25 Unknown Tylenol Cold Multi-Symptom Daytime Non-Drowsy Rapid Release Gels Label

D00002140 TYLNJ 09218329 Unknown Tylenol Cold Multi-Symptom Daytime Non-Drowsy Rapid Release Gels Label

D00002141 TYLNJ 09218400 Unknown Tylenol Cold Multi-Symptom Nighttime Cool Burst Liquid – Labels

D00002142 TYLNJ 09218255 Unknown Tylenol Cold Multi-Symptom Warming Honey Lemon – Nighttime Label

D00002143 TYLNJ 09220893 Unknown Tylenol Cold Severe Head Congestion Cool Burst Caplets label

D00002144 TYLNJ 09219018 Unknown Tylenol Cold Severe Head Congestion Cool Burst Daytime Non-Drowsy Caplets label

D00002145 TYLNJ 09218908 Unknown Tylenol Cold Severe Multi-Symptom Cool Burst Liquid Label

D00002146 TYLNJ 09220276 Unknown Tylenol Cough & Sore Throat Daytime Labels

D00002147 TYLNJ 09220275 Unknown Tylenol Cough & Sore Throat Daytime Non-Drowsy with instant Cool Burst Sensation Labels

D00002148 TYLNJ 09219591 Unknown Tylenol Cough & Sore Throat Daytime-Non-drowsy with instant Cool Burst Label


D00002149 TYLNJ 09219689 Unknown Tylenol Cough & Sore Throat Nighttime Drug Facts label

D00002150 TYLNJ 09219688 Unknown Tylenol Cough & Sore Throat Nighttime with instant Cool Burst Sensation

D00002151 TYLNJ 09221632-33 Unknown Tylenol Extra Strength Cool Caplets NDC#710 UPC#444 Drug Product Listing & labels

D00002152 TYLNJ 09221913 Unknown Tylenol Extra Strength Cool Caplets NDC#710 UPC#444 Drug Product Listing & labels

D00002153 TYLNJ 06014223–55 Unknown Tylenol Extra Strength Crushable/Dye Free Tablets Label

D00002154 TYLNJ 09222747 Unknown Tylenol Extra Strength Go Tabs Chewable Tablets NDC#410 UPC#410 Drug Product Listing & labels

D00002155 TYLNJ 09221589 Unknown Tylenol Extra Strength Go Tabs Chewable Tablets NDC#410 UPC#410 Drug Product Listing & labels

D00002156 TYLNJ 06013860-68 Unknown Tylenol Extra Strength Table Family Code Number: 499 NDC# 50580-499-XX Drug Facts

D00002157 TYLNJ 09223343-46 Unknown Tylenol PM extra strength geltabs label

D00002158 TYLNJ 09223927 Unknown Tylenol PM Rapid Release Gels Label

D00002159 TYLNJ 09217701 Unknown Tylenol Regular Strength Caplets Label

D00002160 TYLNJ 09222962-68 Unknown Tylenol Regular Strength Caplets Label

D00002161 TYLNJ 09223918-21 Unknown Tylenol Regular Strength Tablets

D00002162 TYLNJ 09222847 Unknown Tylenol Regular Strength Tablets Label

D00002163 TYLNJ 09223876 Unknown Tylenol Regular Strength Tablets NDC#496 UPC#496 Drug Product Listing & Labels

D00002164 TYLNJ 09223878 Unknown Tylenol Regular Strength Tablets NDC#496 UPC#496 Drug Product Listing & Labels

D00002165 TYLNJ 06014153-161 Unknown Tylenol Severe Cold & Flu Caplets Label

D00002166 TYLNJ 09220793 Unknown Tylenol Severe Cold & Flu Warming Honey Lemon Label

D00002167 TYLNJ 09220794 Unknown Tylenol Severe Cold & Flu Warming Honey Lemon Label

D00002168 TYLNJ 09220795 Unknown Tylenol Severe Cold Head Congestion Caplets

D00002169 TYLNJ 09220338 Unknown Tylenol Severe Cold Multi-Symptom Cool Burst Labels

D00002170 TYLNJ 09220336 Unknown Tylenol Severe Cold Multi-Symptom Cool Burst Labels

D00002171 TYLNJ 09220301 Unknown Tylenol Severe Sinus & Allergy Cool Burst Caplets Label

D00002172 TYLNJ 09218564 Unknown Tylenol Severe Sinus & Allergy Cool Burst Caplets Label

D00002173 TYLNJ 09218506 Unknown Tylenol Severe Sinus Congestion & Pain Cool Burst Caplets Label

D00002174 TYLNJ 09217966 Unknown Tylenol Severe Sinus Congestion & Pain Daytime Non-Drowsy - Label

D00002175 TYLNJ 09222895-900 Unknown Tylenol Sinus Congestion & Pain Daytime Non-Drowsy Cool Burst Caplets

D00002176 TYLNJ 09220950 Unknown Tylenol Sinus Congestion & Pain Rapid Release Daytime Non-Drowsy Gels Label


D00002177 TYLNJ 09221206 Unknown Tylenol Sore Throat Daytime Non-Drowsy with Instant Cool Burst Sensation Label

D00002178 TYLNJ 09219814 Unknown Tylenol Warming Cough & Severe Congestion Honey Lemon Daytime Liquid Label

D00002179 Tylenol® Dosing for Adults. TYLENOL®. http://www.tylenol.com/safety-dosing/usage/dosage-for-adults

D00002180 TYLNJ 00567675-00567676 Unknown "An Important Message to All Physicians" published by McNeil

D00002181 Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations

www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm090016.htm

D00002182 Title 21 U.S.C. § 211, 211.84(d)(6)

D00002183 Title 21 U.S.C. § 211, 211.113(a)

D00002184 Title 21 U.S.C. § 211, 211.165(b)

D00002185 USP-NF, www.usp.org/usp-nf

D00002186 About USP, www.usp.org/about-usp

D00002187 USP Mission and History, www.usp.org/about-usp/our-impact/mission-history

D00002188 Legal Recognition of USP Standards, www.usp.org/about-usp/legal-recognition

D00002189 Human Drg CGMP Notes

D00002190 USP 30 (2007)


D00002192 NF 26 (2008) monograph, Microcrystalline cellulose and carboxymethylcellulose sodium

D00002193 Microcrystalline cellulose and carboxymethylcellulose sodium fact sheets

D00002194 Avicel RC-591 Material Safety Data Sheet

D00002195 TYLNJ 02524375-404 8/27/2009 Projections of Net Change in US Adult Deaths Based on Switching from Acetaminophen to NSAIDs

D00002196 TYLNJ 02490801-20 No date Executive Summary regarding FDA public meeting on acetaminophen products

D00002197 TYLNJ 02490821 6/9/2009 Correspondence from Vicki Wagner-Weber regarding Briefing Document for FDA Advisory Committee Meeting


D00002199 TYLNJ 02627465 7/22/2004 Correspondence from Kaelin O'Connell regarding NDA 19-872 approval and request letters for 90 day extension on ADE Report

D00002200 TYLNJ 02627472-73 9/18/2002 Correspondence from Steven Waller regarding US FDA OTC Analgesics Meeting

D00002201 TYLNJ 02627474-75 No date Acetaminophen Facts and New Labeling Initiatives

D00002202 TYLNJ 02627476-82 No date Acetaminophen : An Overview


D00002203 TYLNJ 02627483-85 No date Selected Over-The-Counter Pain Reliever Published Studies

D00002204 TYLNJ 02627486-507 No date Update: NDAC Meeting to Be Held September 2002

D00002205 TYLNJ 02627512-13 1/22/2004 Correspondence from Minnie Baylor-Henry to Jeffrey Baggish regarding press material from FDA

D00002206 TYLNJ 02627545 10/27/2003 Correspondence from Willie Pagsuyuin regarding final Clinical Expert Statement (for European submission)

D00002207 TYLNJ 02627546-91 10/23/2003 Clinical Expert Statement

D00002208 TYLNJ 02627592-93 12/10/2004 Correspondence from Timothy Pribilski to Anthony Temple regarding Partial Response to Liver Warning implementation on Tylenol products

D00002209 TYLNJ 02628909 12/18/2008 Correspondence from Lynn Pawelski regarding acetaminophen labeling

D00002210 TYLNJ 02628919 2/12/2009 Correspondence from Lynn Pawelski to Marc Boston regarding acetaminophen overdose media statement

D00002211 TYLNJ 02628924 3/29/2009 Correspondence from Ed Kuffner to Peter Luther and Lynn Pawelski regarding AHRQ overview

D00002212 TYLNJ 02628931-32 4/20/2009 Correspondence from Lynn Pawelski to Richard D'Souza regarding TAR SNDA User Fee

D00002213 TYLNJ 02628938-40 4/23/2009 Correspondence from Vicki Wagner-Weber regarding June 29 and 30, 2009 Advisory Committee Meeting

D00002214 TYLNJ 02628941 04/23/2009 Correspondence from Thomas Mrazik regarding FR Notice April 23, Push of Info to Canada/Row

D00002215 TYLNJ 02628947 4/26/2009 Correspondence from Lynn Pawelski regarding AHRQ 4/26/09 Draft

D00002216 TYLNJ 02628948-50 4/27/2009 Draft correspondence to Doris Lefkowitz regarding Proposed Agency Information Collection Activities Understanding Patients' Knowledge and Use of Acetaminophen

D00002217 TYLNJ 02628951 4/27/2009 Correspondence from Thomas Mrazik regarding AHRQ 4/26/09 Draft

D00002218 TYLNJ 02628986 4/29/2009 Correspondence from Lynn Pawelski regarding AHRQ letter 042709

D00002219 TYLNJ 02628987-90 4/27/2009 Correspondence from Lynn Pawelski to Doris Lefkowitz regarding Proposed Agency Information Collection Activities Understanding Patients' Knowledge and Use of Acetaminophen

D00002220 TYLNJ 02629014-15 5/1/2009 Correspondence from Lynn Pawelski to Peter Luther regarding APAP Advisory Committee Meeting

D00002221 TYLNJ 02629028 5/4/2009 Correspondence from Thomas Mrazik to Lynn Pawelski regarding APAP summit

D00002222 TYLNJ 02629170-71 5/7/2009 Correspondence from Christina Jessurun to Joseph Rickard regarding Sequoia costs

D00002223 TYLNJ 02629172-93 No date Project Sequoia Cost Summary

D00002224 TYLNJ 02629195-96 2009 Financial Assessment



D00002226 TYLNJ 02629446-47 5/27/2009 Correspondence from Gary Benedict regarding statement on FDA's options paper on acetaminophen

D00002227 TYLNJ 02629448-49 5/27/2009 CHPA Statement from the Consumer Healthcare Products Association (CHPA) on FDA's Options Paper Regarding Acetaminophen

D00002228 TYLNJ 02629524 5/29/2009 Correspondence from Louis Calzia regarding Sequoia Strategy and Action Plans

D00002229 TYLNJ 02629525-32 No date Sequoia Strategy & Action Plans

D00002230 TYLNJ 04478199-200 06/19/2009 Email from Louis Calzi re: Adcom Resources Deck

D00002231 TYLNJ 04478476-477 06/26/2009 Email from Bryan Vaughn re: CHPA Slides Changes and Scripts

D00002232 TYLNJ 04478619 06/27/2009 Email from Bonnie Jacobs re: Revised Press Statements

D00002233 TYLNJ 04478620-621 06/29 - 30/2009 McNeil Consumer Healthcare Statement/FDA APAP Advisory Committee Meeting

D00002234 TYLNJ 04479108 07/02/2009 Email from Peter Luther re: Advocacy Plan

D00002235 TYLNJ 04479112 07/02/2009 Email from Desiree Ralls-Morrison re: J. Woodcock Approach

D00002236 TYLNJ 04479498 07/12/2009 Email from Vicki Wagner-Weber re: draft meeting request letter

D00002237 TYLNJ 04479499-508 No date Letter to Charles Ganley, MD Director of the FDA from Lynn Pawelski, VP Regulatory Affairs, McNeil Consumer Health re: NDA 19-872, Tylenol (acet) 650 mg extended-release tablets, Risk Mitigation Plan, Type A Meeting Request

D00002238 TYLNJ 04479659 07/14/2009 Email from Desiree Ralls-Morrison re: Summary of McNeil's position

D00002239 TYLNJ 04479660 07/14/2009 Summary of McNeil Consumer Healthcare's Strategy in Response to FDA's June 2009 Advisory Committee Meeting on Acetaminophen

D00002240 TYLNJ 04479762-763 07/15/2009 Email from Barbara Kochanowski re: Feedback from FDA-Analgesics final rule - warnings

D00002241 TYLNJ 04479764-766 05/26/2009 Letter to Michael S. Furness, Ph.D., Director of the Div. of Nonprescription Reg. Development, FDA from Heinrich Schneider, Dr.Med, VP Science & Medical Affairs and Barbara Kochanowski, PhD., VP of Reg. Affairs re: Organic-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human use/Docket No. FDA-1977-N-0013

D00002242 TYLNJ 04479895-898 07/27/2009 Email from Lynn Pawelski re: IEI Suggested Approach

D00002243 TYLNJ 04479981 07/29/2009 Email from Mark Senak re:Stakeholder Draft 07-29-09 Legal Edits with Switch Data

D00002244 TYLNJ 04479982-80007 05/06/2012 Report re: Appropriate Use and Access to Acetaminophin - Important Considerations Following FDA Advisory Committee Meetings Held on June 29-30, 2009


D00002245 TYLNJ 04480042 07/30/2009 Email from Desiree Ralls-Morrison re: McNeil Letter to FDA fro APAP Dosing Changes - SCRUBBED on 07-24-09

D00002246 TYLNJ 04481197 09/04/2009 Email from Peter Luther re: meeting request

D00002247 TYLNJ 04482368 11/20/2009 Email from Megha Shah re: TYL PM and Motrin IB; Labeling Complaints and Dosing Inquiries

D00002248 TYLNJ 04482722-723 12/22/2009 Email from Peter Luther re: Tylenol PM Labeling

D00002249 TYLNJ 04482746-749 12/29/2009 Email from Joan Cohen re: Tylenol PM

D00002250 TYLNJ 04482788 01/12/2010 Email from Lynn Pawelski re: Draft Peter Note

D00002251 TYLNJ 04483033 02/05/2010 Email from Lynn Pawelski re: Draft FDA Presentation

D00002252 TYLNJ 04484709 06/14/2010 Email from Gerald Masoudi re: Letter re: Tylenol PM

D00002253 TYLNJ 04484715-717 06/14/2010 Email from Gerald Masoudi re: Letter re: Tylenol PM

D00002254 TYLN 04485308-311 06/01/2010 Email from Peter Luther re: Dr. Ganley's letter of June 10, 2010

D00002255 TYLNJ 04485391 07/21/2010 Email from Vicki Wagner-Weber re: FDA - Janet Letter 071610_draft

D00002256 TYLNJ 04485392-393 07/21/2010 Letter to Janet Woodcock, MD Director for Drug Evaluation and Research FDA re: Risk Management Plan for OTC Acetaminophen Products

D00002257 TYLNJ 04484710-714 12/23/2009 Letter to Michael Levy, Div. of New Drugs and Labeling Compliance, FDA from Gerald Masoudi, Covington & Burling LLP responding to recent inquiry re: McNeil's position and intentions re: TYLENOL PM.

D00002258 TYLNJ 04485406-407 07/30/2010 Email from Peter Luther re: McNeil Risk Management Plan Update

D00002259 TYLNJ 04485478 08/06/2010 Email from Lindsay Herman re: Slide

D00002260 TYLNJ 04485479 08/06/2010 Launch Plan Update

D00002261 TYLNJ 04485528 08/11/2010 Email from Peter Luther to Janet Woodcock re: Your Email (proposed language as outlined by FDA)

D00002262 TYLNJ 04486106-107 10/11/2010 Email from Lynn Pawelski to Vicki Wagner-Weber re: Sequoia Update

D00002263 TYLNJ 04486213 10/19/2010 Email from Lynn Pawelski to Desiree Ralls-Morrison re: DRAFT ROC

D00002264 TYLNJ 04486214-215 10/19/2010 McNeil Consumer Healthcare Record of Contact

D00002265 TYLNJ 04486253-254 11/3/2010 Email from Peter Luther re: Update on McNeil Risk Management Plan

D00002266 TYLNJ 04486288 11/24/2010 Email from Lynn Pawelski to Barbara Kochanowsk re: Attached FDA response to McNeil regarding Acetaminophen Risk Mitigation Plan

D00002267 TYLNJ 04486289-292 6/10/2010 Letter to McNeil Consumer Healthcare c/o Peter Luther from Charles Ganley, MD Director Off of Drug Eval IV, Center for Drug Eval and Research resonding to requests made to the FDA by McNeil at 02/23/2010 metting re: McNeil's proposed acetaminophen "Risk Mitigation Plan".

D00002268 TYLNJ 04486399-401 1/24/2011 Email from Lynn Pawelski re: Acetaminophin


D00002269 TYLNJ 04486402-406 12/13/2010 Letter to Sandra Kweder, Assoc Dir. Office of New Drug Eval. FDA and Charles Ganley, Dir. Office of Drug Eval VI FDA from Peter Luther, McNeil re: Risk Management Plan for OTC Acetaminophin Products

D00002270 TYLNJ 05384911-912 6/29/2009 Email from Whitney Seamons re: UK apap size restrictions; consumer shift to ibu; paracetamol remains market leader

D00002271 TYLNJ 05384913-924 No date Graphs re: UK Market Changes Due to Pack Size Restrictions Consumer Shift to Increased Use of OTC-Ibuprofen

D00002272 TYLNJ 05385279-280 3/15/2010 Email from Lynn Pawelski re: Tylenol PM

D00002273 TYLNJ 05385281-282 4/20/2010 Email from Lynn Pawelski re: Draft letter - Ty Peds Doscing under 2

D00002274 TYNJ 05385283-285 No date Letter to Charles Ganley, Dir. Off of Drug Eval IV, FDA from Lynn Pawelski, VP Global Reg. Affairs

D00002275 TYLNJ 05385946-950 1/17/2011 Email from Lynn Pawelski re: FDA's recommendation regarding prescription acetaminophen containing products

D00002276 TYLNJ 05385951-953 1/24/2011 Email from Lynn Pawelski re: Acetaminophin

D00002277 TYLNJ 05430359 6/7/2009 Email from Thomas Mrazik to Lynn Pawelski re: Comments CHPA Draft

D00002278 TYLNJ 05430360-387TYLNJ 05430883-910

6/6/2009 Briefing Book Submitted by the Consumer Healthcare Products Assoc.

D00002279 TYLNJ 05430432-33 6/25/2009 Email from Bryan Vaughn re: OTC Acetaminophin Count Restriction Assoc. - Topline Findings

D00002280 TYLNJ 05430434-455 6/1/2009 Tylenol EST Packaging Study - Topline Report

D00002281 TYLNJ 05430881-882 6/7/2009 Email from Lynn Pawelski re: Comments CHPA Draft

D00002282 TYLNJ 05430911-919 No date Collective work and views of CHPA member companies which currently market OTC products containing acetaminophen

D00002283 TYLNJ 05431045 7/1/2009 Email from Jennifer Cullen re: Advisory Committee Healthcare Professional Letters

D00002284 TYLNJ 05431046-047 6/29/2009 Letter from Edwin K Kuffner, Senior Med Dir., Med Affairs, McNeil to colleagues re: Important info about the use of acetamimophen

D00002285 TYLNJ 05431048 7/1/2009 Letter from Edwin K Kuffner, Senior Med Dir., Med Affairs, McNeil to colleagues re: Important info related to the safe use of acetamimophen

D00002286 TYLNJ 05431088 6/19/2009 Email from Vicki Wagner-Weber re: RiskMap new Objective

D00002287 TYLNJ 05431089 No date Goal 2: Reduce Intentional Ingestions and Unintentional Medication Errors that Lead to Acetaminophen Overdose and/or Liver Injury in Adults

D00002288 TYLNJ 05431899-1900 9/25/2009 Email from David Graham re: Alliance for Aging Research - Survey Results

D00002289 TYLNJ 05431931-935 No date Alliance for Aging Research, Survey of Older Americans' Attitudes About Pain Management


D00002290 TYLNJ 05431974-975 8/26/2009 Email from Lynn Pawelski re: 2010 Sequoia Spending - Action Required

D00002291 TYLNJ 05431976-999 2009 2009 P&L

D00002292 TYLNJ 05432237 12/1/2009 Email from Ed Kuffner re: Sequoia Attitude + Behavior Attitude SRAP

D00002293 TYLNJ 05432238 11/29/2009 Strategic Research Action Plan (SRAP)

D00002294 TYLNJ 05432240-251 11/19/2009 APAP Usage among the General Population in the US

D00002295 TYLNJ 05432424-427 11/5/2009 Email from Lynn Pawelski re: Reuters.com - US FDA aims to fight avoidable harm from medicines

D00002296 TYLNJ 05433138 1/11/2010 Email from Thomas Mrazik re: CHPA Slides: FDA Safe Use Meeting

D00002297 TYLNJ 05433139-168 1/5/2010 Consumer Healthcare Products Association - FDA Safe Use Initiative: OTC industry perspectives

D00002298 TYLNJ 05435015 2/19/2010 Email from Vicki Wagner-Weber re: Tylenol PM citizen petition

D00002299 TYLNJ 05435016-030 2/19/2010 Citizen Petition to Division of Dockets Management, FDA from Lynn Pawelski, McNeil

D00002300 TYLNJ 05435036 2/22/2010 Email from Kate McGinley re: Study overview for FDA 2.22.10

D00002301 TYLNJ 05435037-041 2/1/2010 McNeil Consumer Healthcare, OTC Risk Mitigation Plan

D00002302 TYLNJ 05436109-110 2/18/2010 Email from Lynn Pawelski re: 2nd draft submission to FDA concerning Tylenol PM studies

D00002303 TYLNJ 05436111-123 1/18/2010 Additional support for Category I Status of Acetaminophine/Diphenhydramine Combination Products in the OTC Monograph for Nighttime Sleep-Aid Drug Products for OTC Use

D00002304 TYLNJ 05438961 4/6/2011 Email from Lynn Pawelski re: Peds Ad Com Overview for Pat

D00002305 TYLNJ 05438962-975 4/6/2011 Pediatric Acetaminophen FDA Advisory Committee Update

D00002306 TYLNJ 05440059-062 6/10/2011 Email from Lynn Pawelski re: Acetaminophin 1000 mg - Dosing Interval

D00002307 TYLNJ 05440160 6/23/2011 Email from Vicki Wagner-Weber re: FDA Meet Request

D00002308 TYLNJ 05440385 6/30/2011 Email from Vicki Wagner-Weber re: Support for Analgesic Claim Indication for Acetaminophin in Children 6-23 months

D00002309 TYLNJ 02490821 6/9/2009 Correspondence from Vicki Wagner-Weber regarding Briefing Document for FDA Advisory Committee Meeting


D00002311 TYLNJ 02627465 7/22/2004 Correspondence from Kaelin O'Connell regarding NDA 19-872 approval and request letters for 90 day extension on ADE Report

D00002312 TYLNJ 02627472-73 9/18/2002 Correspondence from Steven Waller regarding US FDA OTC Analgesics Meeting

D00002313 TYLNJ 02627474-75 No date Acetaminophen Facts and New Labeling Initiatives


D00002314 TYLNJ 02627476-82 No date Acetaminophen : An Overview

D00002315 TYLNJ 02627483-85 No date Selected Over-The-Counter Pain Reliever Published Studies

D00002316 TYLNJ 02627486-507 No date Update: NDAC Meeting to Be Held September 2002

D00002317 TYLNJ 02627512-13 1/22/2004 Correspondence from Minnie Baylor-Henry to Jeffrey Baggish regarding press material from FDA

D00002318 TYLNJ 02627545 10/27/2003 Correspondence from Willie Pagsuyuin regarding final Clinical Expert Statement (for European submission)

D00002319 TYLNJ 02627546-91 10/23/2003 Clinical Expert Statement

D00002320 TYLNJ 02627592-93 12/10/2004 Correspondence from Timothy Pribilski to Anthony Temple regarding Partial Response to Liver Warning implementation on Tylenol products

D00002321 TYLNJ 02628909 12/18/2008 Correspondence from Lynn Pawelski regarding acetaminophen labeling

D00002322 TYLNJ 02628919 2/12/2009 Correspondence from Lynn Pawelski to Marc Boston regarding acetaminophen overdose media statement

D00002323 TYLNJ 02628924 3/29/2009 Correspondence from Ed Kuffner to Peter Luther and Lynn Pawelski regarding AHRQ overview

D00002324 TYLNJ 02628931-32 4/20/2009 Correspondence from Lynn Pawelski to Richard D'Souza regarding TAR SNDA User Fee

D00002325 TYLNJ 02628938-40 4/23/2009 Correspondence from Vicki Wagner-Weber regarding June 29 and 30, 2009 Advisory Committee Meeting

D00002326 TYLNJ 02628941 04/23/2009 Correspondence from Thomas Mrazik regarding FR Notice April 23, Push of Info to Canada/Row

D00002327 TYLNJ 02628947 4/26/2009 Correspondence from Lynn Pawelski regarding AHRQ 4/26/09 Draft

D00002328 TYLNJ 02628948-50 4/27/2009 Draft correspondence to Doris Lefkowitz regarding Proposed Agency Information Collection Activities Understanding Patients' Knowledge and Use of Acetaminophen

D00002329 TYLNJ 02628951 4/27/2009 Correspondence from Thomas Mrazik regarding AHRQ 4/26/09 Draft

D00002330 TYLNJ 02628986 4/29/2009 Correspondence from Lynn Pawelski regarding AHRQ letter 042709

D00002331 TYLNJ 02628987-90 4/27/2009 Correspondence from Lynn Pawelski to Doris Lefkowitz regarding Proposed Agency Information Collection Activities Understanding Patients' Knowledge and Use of Acetaminophen

D00002332 TYLNJ 02629014-15 5/1/2009 Correspondence from Lynn Pawelski to Peter Luther regarding APAP Advisory Committee Meeting

D00002333 TYLNJ 02629028 5/4/2009 Correspondence from Thomas Mrazik to Lynn Pawelski regarding APAP summit

D00002334 TYLNJ 02629170-71 5/7/2009 Correspondence from Christina Jessurun to Joseph Rickard regarding Sequoia costs


D00002336 TYLNJ 02629195-96 2009 Financial Assessment



D00002338 TYLNJ 02629446-47 5/27/2009 Correspondence from Gary Benedict regarding statement on FDA's options paper on acetaminophen

D00002339 TYLNJ 02629448-49 5/27/2009 CHPA Statement from the Consumer Healthcare Products Association (CHPA) on FDA's Options Paper Regarding Acetaminophen

D00002340 TYLNJ 02629524 5/29/2009 Correspondence from Louis Calzia regarding Sequoia Strategy and Action Plans


D00002342 TYLNJ 02629662 6/5/2009 Correspondence from Teresa Panas to Lynn Pawelski regarding Ed Campaign Stragey documents

D00002343 TYLNJ 02629843 6/10/2009 Correspondence from Ed Kuffner to James DiBiasi regarding RMPDC's Submission

D00002344 TYLNJ 02629890 6/11/2009 Correspondence from Peter Luther to Lynn Pawelski regarding Packaging Changes

D00002345 TYLNJ 02629893-95 6/12/2009 Correspondence from Virginia Cox regarding Discussion Guide Revisions - Update

D00002346 TYLNJ 02629896-97 No date Acetaminophen Formative Research Program

D00002347 TYLNJ 02629940 6/15/2009 Correspondence from Lynn Pawelski to Kathy Widmer regarding Packaging Changes

D00002348 TYLNJ 02629941-43 6/15/2009 Correspondence from Whitney Seamons to Lynn Pawelski regarding Discussion Guide Revisions - Update

D00002349 TYLNJ 02630481-82 6/26/2009 Correspondence from Desiree Ralls-Morrison to Michele Darnell regarding Draft of internal communication for Monday AM -- FOR REVIEW

D00002350 TYLNJ 02630834-35 7/1/2009 Correspondence from Vicki Wagner-Weber to Lynn Pawelski regarding fyi -draft - not been sent - need to add statement about how they can move forward if questioned by their HA - can add our agree/disagree slide

D00002351 TYLNJ 02632993 9/8/2009 Correspondence from Lynn Pawelski to Christina Jessurun regarding Will you be on the call tomorrow with global at 7 AM

D00002352 TYLNJ 02633231-32 9/24/2009 Correspondence from Peter Luther to Lynn Pawelski regarding Docket Submissions

D00002353 TYLNJ 02638199 2/19/2010 Correspondence from Louis Calzi regarding the Latest Q&A deck

D00002354 TYLNJ 02638205 2/22/2010 Correspondence from Vicki Wagner-Weber regarding General Advice Letter: NDA 19872 S-033

D00002355 TYLNJ 02638324 3/5/2010 Correspondence from Vicki Wagner-Weber to Lynn Pawelski regarding talking points - draft

D00002356 TYLNJ 02638884 12/4/2009 Correspondence from Lynn Pawelski regarding Draft 2010 OGSM

D00002357 TYLNJ 02640345-47 7/14/2010 Correspondence from Lindsay Herman to Theresa Agnew regarding Comments for Marc Robinson business review - need response today


D00002358 TYLNJ 02640384-86 7/19/2010 Correspondence from Lynn Pawelski to Patrice Wright and Robert Bothwell regarding Comments for Marc Robinson business review - need response today

D00002359 TYLNJ 02640640 8/10/2010 Correspondence from Lynn Pawelski to Walter Ellenburg regarding Acetaminophen-Diphenhydramine (Internal Analgesic-Nighttime Sleep Aid) Combinations

D00002360 TYLNJ 02640641-55 3/31/2010 Correspondence from Lynn Pawelski to Dr. Ganley regarding Nighttime Sleep-Aid for Over-the-Counter (OTC) Human Use: Final Monograph

D00002361 TYLNJ 02640813-16 10/29/2010 Correspondence from Lynn Pawelski to Doris Lefkowitz regarding Proposed Agency Information Collection Activities Understanding Patients' Knowledge and Use of Acetaminophen - Phase 2

D00002362 TYLNJ 04474269 4/23/2009 Correspondence from Thomas Mrazik to Lynn Pawelski & Vicki Wagner-Weber regarding APAP

D00002363 TYLNJ 04474277-78 4/23/2009 Correspondence from Lynn Pawelski to Krista Scaldwell & Darrel Jodrey regarding Advisory Committee Meeting Announcement

D00002364 TYLNJ 04474286-88 4/23/2009 Correspondence from Lynn Pawelski to Michele Goodrich regarding Advisory Committee Meeting Announcement

D00002365 TYLNJ 04474296-98 4/23/2009 Correspondence from Michele Goodrich to Lynn Pawelski regarding Advisory Committee Meeting Announcement

D00002366 TYLNJ 04474299-300 4/23/2009 Correspondence from Peter Luther to Lynn Pawelski regarding Advisory Committee Meeting Announcement

D00002367 TYLNJ 04474308-09 4/23/2009 Correspondence from Lynn Pawelski to Peter Luther regarding Advisory Committee Meeting Announcement






D00002373 TYLNJ 04474337-39 4/23/2009 Correspondence from Mary Jo Maguire regarding Advisory Committee Meeting Announcement

D00002374 TYLNJ 04474349-52 4/24/2009 Correspondence from Mark Watt regarding US FDA Advisory Committee Meeting Announcement

D00002375 TYLNJ 04474527-37 4/28/2009 Correspondence from Peter Luther to Lynn Pawelski regarding New FDA rule/pain relievers coverage

D00002376 TYLNJ 04474678-79 4/29/2009 Correspondence from Peter Luther to Barbara Kochanowski regarding Response Requested - Analgesics - Safety


D00002377 TYLNJ 04474680-90 4/29/2009 Correspondence from Lynn Pawelski to Richard D'Souza regarding New FDA rule/pain relievers coverage

D00002378 TYLNJ 04474745 5/3/2009 Correspondence from Vicki Wagner-Weber to Lynn Pawelski (home) regarding Global update

D00002379 TYLNJ 04474748-49 4/28/2009 APPROVED media response STATEMENT Questions & Answers

D00002380 TYLNJ 04474904-05 5/10/2009 Correspondence from Lynn Pawelski to Louis Calzi regarding Sequoia Core Team Agenda for Monday

D00002381 TYLNJ 04474906-32 TYLNJ 04476194-209

5/00/2009 Acetaminophen Update

D00002382 TYLNJ 04474949 5/11/2009 Correspondence from Barbara Kochanowski regarding May 12 APAP Task Group meeting

D00002383 TYLNJ 04474950-61 2007 Original Research Articles: Does Therapeutic Use of Acetaminophen Cause Acute Liver Failure?

D00002384 TYLNJ 04474972 5/11/2009 Correspondence from Lynn Pawelski to Desiree Ralls-Morrison regarding May 12th APAP Task Group meeting

D00002385 TYLNJ 04474973-84 2007 Original Research Articles: Does Therapeutic Use of Acetaminophen Cause Acute Liver Failure?

D00002386 TYLNJ 04475004 5/13/2009 Correspondence from Lynn Pawelski to Vicki Wagner-Weber regarding Analgesics Final Labeling Rule - Letter to FDA requesting extention of compliance period and clarifications

D00002387 TYLNJ 04475009-11 TYLNJ 04475098-100

5/22/2009 Correspondence from Heinrich Schneider to Charles Ganley regarding Federal Register / Vol. 74, No. 81 / April 29, 2009 [P. 19385-19409] (Final rule)

D00002388 TLYNJ 04475026-29 No date Slides of Potential Root Causes & Teams and Actions Plans

D00002389 TYLNJ 04475037 5/18/2009 Correspondence from Andrew Fish regarding: Response Requested CHPA Acetaminophen Task Group Agreement

D00002390 TYLNJ 04475038-41 5/18/2009 Acetaminophen Task Group Agreement outline

D00002391 TYLNJ 04475047 5/19/2009 Correspondence from Stephanie Kaul regarding Sequioa Standby Statement

D00002392 TYLNJ 04475048-49 5/19/2009 McNeil Consumer Healthcare FDA APAP Advisory Committee: MEDIA STANDBY STATEMENT

D00002393 TYLNJ 04475068-69 5/20/2009 Correspondence from Peggy Ballman regarding CHPA syandby for Friday

D00002394 TYLNJ 04475070-72 TYLNJ 04475080-82

5/22/2009 Statement from the Consumer Healthcare Products Association (CHPA) on FDA's Options Paper Regarding Acetaminophen

D00002395 TYLNJ 04475073-76 TYLNJ 04475083-85

5/19/2009 Option Paper: DRAFT Talking Points

D00002396 TYLNJ 04475078-79 5/20/2009 Correspondence from Lynn Pawelski to Desiree Ralls-Morrison & Joan Cohen regarding CHPA standby for Friday


D00002397 TYLNJ 04475087-88 5/20/2009 Correspondence from Desiree Ralls-Morrison to Lynn Pawelski regarding CHPA standby for Friday

D00002398 TYLNJ 04475096-97 5/20/2009 Correspondence from Heinz Schneider regarding Analgesics Final Labeling Rule - Letter to FDA requesting extention of compliance period and clarifications

D00002399 TYLNJ 04475147-48 5/27/2009 Correspondence from Mimi Pappas regarding FDA's acetaminophen briefing materials are online

D00002400 TYLNJ 04475149-50 5/27/2009 Statement from the Consumer Healthcare Products Association (CHPA) on FDA's Options Paper Regarding Acetaminophen

D00002401 TYLNJ 04475446 5/29/2009 Correspondence from Louis Calzi regarding Sequoia Strategy and Action Items - DRAFT


D00002403 TYLNJ 04475777 No date Estimates and Consequences of Switching from Acetaminophen to NSAIDS

D00002404 TYLNJ 04476101-112 No date Consumer need for OTC Combinations Products

D00002405 TYLNJ 04476225-26 6/4/2009 Correspondence from Lynn Pawelski to Barbara Kochanowski regarding Acetaminophen - Two Questions

D00002406 TYLNJ 04476631 6/5/2009 Correspondence from Peter Luther regarding Recent meeting notes

D00002407 TYLNJ 04476632-33 No date Feedback and Suggestions from Meetings

D00002408 TYLNJ 04477784 6/11/2009 Correspondence from Employee Announcements regarding An Acetaminophen Update from Lynn Pawelski and Ed Kuffner


D00002410 TYLNJ 04477878 6/11/2009 Correspondence from Stephanie Kaul regarding Sequioa Communications Response Plan

D00002411 TYLNJ 04477879-83 6/00/2009 Sequoia Response Plan

D00002412 TYLNJ 04478031-34 6/16/2009 Correspondence from Leslie Shur to Barbara Kochanowski regarding McNeil data for OTC combination products

D00002413 TYLNJ 04478035 No date TYLENOL Brand Multi-ingredient Acetaminophen Products - Possible Drug-Related Hepatic Disorders

D00002414 TYLNJ 04478049-53 6/16/2009 Correspondence from Sandra Schoenewald to Barbara Kochanowski regarding McNeil data for OTC combination products

D00002415 TYLNJ 04478054-55 No date TYLENOL Brand Multi-ingredient Acetaminophen Products - Serious Adverse Events in Post-Marketing Database

D00002416 TYLNJ 04478148-49 6/17/2009 Correspondence from Lynn Pawelski to Desiree Ralls-Morrison regarding: Response Requested -- CHPA Acetaminophen Task Group Agreement

D00002417 TYLNJ 04478150-53 5/18/2009 Acetaminophen Task Group Agreement


D00002418 TYLNJ 05440386 - 468 6/30/2011 Correspondece from McNeil Consumer Healthcare re: Support for Pain Relief Indiciation for Acetaminophen in Children 6 to 23 Months of Age

D00002419 TYLNJ 05440770 - 778 7/26/2011 Final Label Change/GRR Media Q&A

D00002420 TYLNJ 05440786 - 787 7/26/2011 Email from Vicki Weber re: Update on Project Sequoia.

D00002421 TYLNJ 05440788 - 796 7/26/2011 Final Label Change/GRR Media Q&A

D00002422 TYLNJ 05440797 - 798 7/26/2011 Final Tylenol Press Release - McNeil Consumer Healthcare Announces Plans for New Dosing Instructions for Tylenol Products

D00002423 TYLNJ 05441504 - 511 No Date McNeil 2011 Strategic Imperatives

D00002424 TYLNJ 05441744 - 745 4/15/2011 Email from Peter Luther re: Announcing the Launch of Get Relief Responsibly!

D00002425 TYLNJ 05443118 - 119 No Date Education Initiative Helps to Ensure the Appropriate use of Acetaminophen - The Makers of Tylenol Provide Resources, New Dosing Instructions and Packaging Enchancements to Encourage American to Get Relief Responsibly

D00002426 TYLNJ 05443313 12/15/2011 Email from Vicki Weber re: Docket Submission and Cover Letter PDFs Attached.

D00002427 TYLNJ 05443383 12/14/2011 Correspondence from McNeil Consumer Healthcare to FDA re: summary of results from McNeil study ACEPAI201.

D00002428 TYLNJ 05445782 1/6/2012 Email from Lindsay Dills re: Sequoia Board Meeting.

D00002429 TYLNJ 05445783 - 789 1/6/2012 Sequoia Board Meeting

D00002430 TYLNJ 05447634 - 635 3/15/2012 Email from Vicki Weber to Lynn Pawelski and Ed Kuffner re: McNeil Consumer Healthcare - Cap text message.

D00002431 TYLNJ 05447971 4/16/2012 Email from Lindsay Dills re: Final Ac Strategy Deck for Roberto.

D00002432 TYLNJ 05447972 - 8011 4/16/2012 Acetaminophen Update

D00002433 TYLNJ 05448617 7/3/2012 Email from Vicki Weber re: FDA draft guidance-organ specific warnings: labeling for products that contain acetaminophen.

D00002434 TYLNJ 05448618 - 623 7/00/2012 Guidance for Industry - Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use - Labeling for Products That Contain Acetaminphen.

D00002435 TYLNJ 05544732 12/8/2004 Email from Anthony Temple re: OARSI: New Citations.

D00002436 TYLNJ 05544733 No Date P-204 Long Term Use of Acetaminpohen in Patients with Osteaoarthritis Pain.

D00002437 TYLNJ 05544734 No Date P-327 Three-Month Efficacy and Safety of Acetaminophen for Osteoarthritis Pain of the Hip or Kne.

D00002438 TYLNJ 05544779 4/30/2004 Email from Jonathan Druhan re: Tylenol 055 poster.

D00002439 TYLNJ 05544946 5/28/2003 Email from Paula Oliver re: Tylenol 8 Hour - FDA Label Approval.


D00002440 TYLNJ 05546329 - 330 4/29/2009 Email from Barbara Kochanowski re: Response Requested - Analgesics - Safety.

D00002441 TYLNJ 05546472 - 473 5/27/2009 Email from Lynn Pawelski re: Statement on FDA's options paper on acetaminophen.

D00002442 TYLNJ 05546474 - 475 5/27/2009 Email from Peter Luther re: Statement on FDA's options paper on acetaminophen.

D00002443 TYLNJ 05546477 5/28/2009 Email from Justin McDonnell to Louis Calzi re: NDAC Strategy Discussion.

D00002444 TYLNJ 05546478 - 479 No Date Strategy Discussion

D00002445 TYLNJ 05546618 6/5/2009 Email from Whitney Seamons to Lynn Pawelski re: What We Have Done.

D00002446 TYLNJ 05546619 No Date What We've Done (Historical Education Efforts)

D00002447 TYLNJ 05546685 6/6/2009 Email from Ed Kuffner to Lynn Pawelski re: Suggestion.

D00002448 TYLNJ 05546729 6/7/2009 Email from Peter Luther re: Ped Recommendation.

D00002449 TYLNJ 05546799 6/15/2009 Email from Whitney Seamons to Lynn Pawelski re: Call w/CHPA to discuss Focus Groups Next Steps

D00002450 TYLNJ 05546800 No Date Proactive Education Plan - Project Sequoia

D00002451 TYLNJ 05546821 - 824 6/16/2009 Email from Barbara Kochanowski to Sandra Schoenewald re: McNeil data for OTC combination products.

D00002452 TYLNJ 05547019 - 020 6/25/2009 Email from Bryan Vaughn re: OTC Acetaminophen Count Restriction Associations - Topline Findings.

D00002453 TYLNJ 05547021 - 042 6/00/2009 Tylenol EST Packaging Study - Topline Report

D00002454 TYLNJ 05547813 - 816 8/31/2009 Email from Lynn Pawelski to Faith Dugan re: Acetaminophen Risk Management.

D00002455 TYLNJ 05548789 - 790 1/4/2010 Email from Peter Luther to Lynn Pawelski and Desiree Morrison re: McNeil Letter.

D00002456 TYLNJ 05550752 - 753 4/28/2010 Email from Lynn Pawelski to Hina Harlow re: Requested Data - Jan_Jun 08 Zyrtec Aes and Emails from CCC.

D00002457 TYLNJ 05550754 - 757 No Date Chart

D00002458 TYLNJ 05551988 7/13/2010 Email from Thomas Mrazik to Lynn Pawelski re: 11/02 Presentation.

D00002459 TYLNJ 05551989 - 2003 6/28/2012 Presentation - Pediatric OTC Safety

D00002460 TYLNJ 05553264 9/9/2010 Email from Lynn Pawelski to Barbara Kochanowski re: Sharfstein Deck.

D00002461 TYLNJ 05553647 - 648 10/2/2010 Email from Lindsay Herman to Peter Luther re: Sequoia: Updated Messaging.

D00002462 TYLNJ 05553649 - 650 00/00/2010 Dear Healthcare Professional - New Dosing Instructions for Extra Strength Tylenol Products

D00002463 TYLNJ 05553707 - 708 10/6/2010 Email from Lindsay Herman to Louis Calzi and Shannon Leber re: Things needed for Washington D.C.

D00002464 TYLNJ 05553805 10/25/2010 Email from Lynn Pawelski from Joan Cohen re: My Comments w Ed's.

D00002465 TYLNJ 05553827 10/29/2010 Email from Thomas Mrazik to Lynn Pawelski re: this is revised today with Joan and Bryan.

D00002466 TYLNJ 05692673 - 674 5/10/2009 Email from Lynn Pawelski to Louis Calzi re: Sequoia Core Team Agenda for Monday.


D00002467 TYLNJ 05692675 - 701 05/00/2009 Acetaminophen Update

D00002468 TYLNJ 05693572 - 574 7/13/2009 Email from Thomas Mrazik to Lynn Pawelski re: Data.

D00002469 TYLNJ 05693575 - 638 6/29/2009 Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee June 29-30, 2009

D00002470 TYLNJ 05693736 8/19/2009 Email from Vicki Weber re: McNeil's supplemental submission to docket.

D00002471 TYLNJ 05693737 - 756 8/18/2009 Correspondence from Lynn Pawelski to FDA re: Docket No. FDA-2009-N-0138, Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee.

D00002472 TYLNJ 05693780 8/28/2009 Email from Vicki Weber re: McNeil Supplemental Submission Rothman.

D00002473 TYLNJ 05693781 - 812 8/28/2009 Correspondence from Lynn Pawelski to FDA re: Docket No. FDA-2009-N-0138, Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee.

D00002474 TYLNJ 05694403 8/28/2009 Email from Lynn Pawelski to Vicki Weber re: Switching Report.

D00002475 TYLNJ 05694516 10/9/2009 Email from Lynn Pawelski re: McNeil submission - sent to the docket.

D00002476 TYLNJ 05694517 - 538 9/30/2009 Correspondence from Lynn Pawelski to FDA re: Docket No. FDA-2009-N-0138, Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee: Risk Management Plan for Over-the-Counter Acetaminophen Products.

D00002477 TYLNJ 05699845 - 848 11/9/2009 Email from Marc Robinson to Lynn Pawelski re: Dosing Devices for OTC Drug Products.

D00002478 TYLNJ 05699849 11/24/2009 Email from Vicki Weber re: Letter to Janet Woodcock.

D00002479 TYLNJ 05699850 - 854 11/24/2009 Correspondence from McNeil Consumer Healthcare to Janet Woodcock re: Risk Management Plan for Over-the-Counter (OTC) Acetaminophen Products.

D00002480 TYLNJ 05700329 - 330 11/3/2010 Email from Peter Luther to Lynn Pawelski and Desiree Morrison re: Update on McNeil Risk Mitigation Plan.

D00002481 TYLNJ 05702345 - 346 7/27/2011 Email from Lynn Pawelski re: Acetaminophen Risk Mitigation Plan.

D00002482 TYLNJ 05702364 - 366 7/27/2011 Email from Lynn Pawelski re: Acetaminophen Risk Mitigation Plan.

D00002483 TYLNJ 05702373 - 376 7/28/2011 Email from Vicki Weber to Lynn Pawelski re: Confidential and Not for Communication until Thursday 10am your time: US Paracetamol dose modification.

D00002484 TYLNJ 02638885 - 886 No Date Global Regulatory Affairs OTC


D00002485 TYLNJ 02638200 No Date What Rationale will McNeil provide to consumers for the change in the total daily dosing (e.g. do you plan to point to hepatotoxicity concerns or is the message to be more generalized)?

D00002486 TYLNJ 02632922 9/4/2009 Email from Desiree Morrison to Lynn Pawelski re: Draft email for Colleen and Marc

D00002487 TYLNJ 02632911 - 918 No Date FDA Working Group and Advisory Committee Recommendations

D00002488 TYLNJ 02632900 - 901 No Date Meeting Agenda

D00002489 TYLNJ 02629663 - 667 6/4/2009 Raising Awareness About Acetaminophen and Tylenol - General Concept Overview: Public Health Initiative

D00002490 TYLNJ 02629844 - 856 6/8/2009 Comments on Liver Injury Related to the Use of Acetaminophen

D00002491 TYLNJ 02630838 - 841 6/29/2009 Joint Meeting of the Drug Safety and Risk Management Advisory Committee, NDAC, and the Anesthetic and Life Support Drugs Advisory Committee: Questions to the Committee

D00002492 Summary of Clinical Study Reports for Adult Acetaminophen Products

D00002493 Summary of Clinical Study Reports for Pediatric Acetaminophen Products

D00002494 Summary of Unpublished Clinical Studies for Adult Acetaminophen Products

D00002495 Summary of Published Clinical Articles for Adult Acetaminophen Products

D00002496 Summary of Published Clinical Articles for Pediatric Acetaminophen Products

D00002497 Summary of Nonclinical Studies Conducted with Acetaminophen

D00002498 TYLNJ 06014195-222 6/8/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Bubblegum Meltaways

D00002499 TYLNJ 06014182-94 6/8/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Grape Punch Meltaways

D00002500 TYLNJ 06014171-78 12/3/2009 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Arthritis Pain Gelcaps NDC#508

D00002501 TYLNJ 06014063-138 3/20/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Extra Strength Rapid Release Gels

D00002502 TYLNJ 06013981-4062 11/30/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Extra Strength Caplets NDC#449 UPC#449


D00002503 TYLNJ 06013819-41 8/24/2010 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Suspension (Grape Splash) NDC#296 UPC#296

D00002504 TYLNJ 06013772-804 4/9/2010 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol PM Extra Strength Rapid Release Gelcaps NDC#244 UPC#244

D00002505 TYLNJ 06013740-71 11/2/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Infant’s Tylenol Suspension Grape NDC#191

D00002506 TYLNJ 06013648-706 5/10/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Extra Strength Tylenol PM Geltabs NDC#176 UPC#176

D00002507 TYLNJ 06013632-47 4/12/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Infants Concentrated Tylenol

D00002508 TYLNJ 06013471-544 11/11/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Suspension (Cherry Blast) NDC#123 UPC#123

D00002509 TYLNJ 06013383-470 9/1/2009 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Arthritis Pain Caplets NDC#112 UPC#838 NDA#19-872

D00002510 TYLNJ 09218094-99 9/27/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Childrens Tylenol Suspension

D00002511 TYLNJ 09218013-20 11/11/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Cherry Blast

D00002512 TYLNJ 09218003-10 6/29/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Sinus Congestion and Pain Severe Caplets

D00002513 TYLNJ 09218153-60 11/1/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Childrens Tylenol Cherry Blast

D00002514 TYLNJ 09218124-29 11/14/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Childrens Tylenol Suspension—Beerse

D00002515 TYLNJ 09218620-26 9/28/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Allergy Multi-Symptom Nighttime Caplets

D00002516 TYLNJ 09218619 9/28/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Allergy Multi-Symptom Nighttime Caplets


D00002517 TYLNJ 09218744-52 5/26/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Childrens Tylenol Suspension Grape-Canada

D00002518 TYLNJ 09218716-24 3/6/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Childrens Tylenol Suspension Grape-Canada

D00002519 TYLNJ 09218693 4/6/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Childrens Tylenol Suspension Grape-Canada

D00002520 TYLNJ 09219322-27 7/25/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Cold & Flu Severe Caplets

D00002521 TYLNJ 09219165-70 11/27/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Arthritis Pain Geltabs

D00002522 TYLNJ 09218822 5/26/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Childrens Tylenol Suspension Grape - Canada

D00002523 TYLNJ 09218815 7/21/2010 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Grape

D00002524 TYLNJ 09220226-29 11/26/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Suspension Beerse Manufacturer

D00002525 TYLNJ 09220196-202 11/26/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Suspension


D00002527 TYLNJ 09219907-13 1/2/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Plus Multi-Symptom Cold Suspension Grape

D00002528 TYLNJ 09219733-38 2/6/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Cough Sore Throat Daytime Liquid

D00002529 TYLNJ 09219514-20 6/4/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Cold and Flu Severe Caplets

D00002530 TYLNJ 09219391-97 7/18/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Cold and Flu Severe Caplets

D00002531 TYLNJ 09220566-72 1/15/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Sinus Congestion Pain Severe Caplets


D00002532 TYLNJ 09220481-87 1/27/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Sinus Congestion Pain Severe Caplets

D00002533 TYLNJ 09220305-11 6/3/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Cold Multi-Symptom Severe Liquid

D00002534 TYLNJ 09221188-94 11/2/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Suspension Bubblegum

D00002535 TYLNJ 09222879-84 6/20/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Regular Strength Tablets

D00002536 TYLNJ 09222860 6/20/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Regular Strength Tablets


D00002538 TYLNJ 09223090 6/4/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Sr. Strength Tylenol Bubblegum Meltaway

D00002539 TYLNJ 09223083-89 12/12/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Regular Strength Caplets

D00002540 TYLNJ 09223062 12/12/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Regular Strength Caplets

D00002541 TYLNJ 09223019-24 5/29/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Regular Strength Caplets

D00002542 TYLNJ 09222997 5/29/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Regular Strength Caplets

D00002543 TYLNJ 09222954-60 1/18/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Sinus Congestion & Pain Caplets

D00002544 TYLNJ 09222951 1/18/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Sinus Congestion & Pain Caplets

D00002545 TYLNJ 09223152 6/27/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Jr Strength Tylenol Bubblegum

D00002546 TYLNJ 09223121-28 6/4/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Jr Strength Tylenol Bubblegum Meltaway


D00002547 TYLNJ 09223285 6/1/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Jr. Strength Tylenol Grape Meltaways

D00002548 TYLNJ 09223277-83 6/1/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Jr. Strength Tylenol Grape Meltaways



D00002551 TYLNJ 09223213-19 6/27/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Jr. Strength Tylenol Grape Meltaways


D00002553 TYLNJ 09223181 6/27/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Strength Tylenol Bubblegum

D00002554 TYLNJ 09223154-59 6/27/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Jr. Strength Tylenol Bubblegum

D00002555 TYLNJ 09223398-404 4/19/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Cold Head Cong Severe Caplets

D00002556 TYLNJ 09223397 4/19/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Cold Head Cong Severe Caplets

D00002557 TYLNJ 09223370-75 5/29/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Extra Strength Tablets

D00002558 TYLNJ 09223342 5/29/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Extra Strength Tablets

D00002559 TYLNJ 09223440 4/26/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Cold Head Cong Sev. Caplets – Bulk Latina Italy

D00002560 TYLNJ 09223583-88 1/9/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Suspension DF Cherry Blast

D00002561 TYLNJ 09223564 1/9/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Suspension DF Cherry Blast


D00002562 TYLNJ 09223504-10 4/26/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Cold Head Cong Sev Caplets-Bulk Latina Italy

D00002563 TYLNJ 09223651 12/23/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Benadryl-D Allergy & Sinus

D00002564 TYLNJ 09223626-31 1/15/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Plus Cough Sore Throat

D00002565 TYLNJ 09223982 12/4/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Extra Strength EZTabs

D00002566 TYLNJ 09224037 12/4/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Extra Strength Tablets

D00002567 TYLNJ 09224145 12/11/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Extra Strength Rapid Release Gels

D00002568 TYLNJ 09224213 12/5/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol CHC Severe Caplets-Bulk Latina Italy

D00002569 TYLNJ 09224239-43 12/5/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol CHC Severe Caplets-Bulk Latina Italy

D00002570 TYLNJ 09224282 12/18/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Sinus Cong Pain Severe Caplets - Latina

D00002571 TYLNJ 09224310-14 12/18/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Sinus Cong Pain Severe Caplets – Latina

D00002572 TYLNJ 09224339 12/19/2013 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Bubblegum Meltaways

D00002573 TYLNJ 06014195-222 6/8/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Bubblegum Meltaways

D00002574 TYLNJ 06014182-194 6/8/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Grape Punch Meltaways

D00002575 TYLNJ 06014171-178 12/3/2009 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Arthritis Pain Gelcaps NDC#508

D00002576 TYLNJ 06014063-138 3/20/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Extra Strength Rapid Release Gels


D00002577 TYLNJ 06013981-4062 11/30/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Extra Strength Caplets NDC#449 UPC#449

D00002578 TYLNJ 06013819-41 8/24/2010 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Suspension (Grape Splash) NDC#296 UPC#296

D00002579 TYLNJ 06013772-804 4/9/2010 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol PM Extra Strength Rapid Release Gelcaps NDC#244 UPC#244

D00002580 TYLNJ 06013740-71 11/2/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Infant’s Tylenol Suspension Grape NDC#191

D00002581 TYLNJ 06013648-706 5/10/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Extra Strength Tylenol PM Geltabs NDC#176 UPC#176

D00002582 TYLNJ 06013632-47 4/12/2012 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Infants Concentrated Tylenol

D00002583 TYLNJ 06013471-544 11/11/2011 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Children’s Tylenol Suspension (Cherry Blast) NDC#123 UPC#123

D00002584 TYLNJ 06013383-470 9/1/2009 FDA Regulatory Submission Via Electronic Submission Gateway (ESG) Using Reed Tech Account re: Tylenol Arthritis Pain Caplets NDC#112 UPC#838 NDA#19-872

D00002585 4/27/2007 American Association for the Study of Liver Diseases (AASLD) Memorandum to FDA regarding public comment regarding TFM 1977N-0094L

D00002586 7/18/2006 American Liver Foundation Press Release

D00002587 TYLNJ 06021634-35TYLNJ 06307692TYLNJ 06308106TYLNJ 09293007-14

7/24/2012 Letter from Eileen Harman, Associate Director of Regulatory Affairs to Andrea Leonard-Segal, M.D. Director of FDA, Office of Drug Evaluaton IV re: Tylenol Arthritis Pain Extended-Release Tablet and Tylenol 8 Hour Extended Release Tablet Periodic Safety Update Report: Summary Bridging Report March 01, 2012- May 31, 2012; Periodic Safety Update Report Attached

D00002588 TYLNJ 03118887-88TYLNJ 06288994-95

4/29/2009 Letter from Eileen Geisinger, Associate Director, Global Regulatory Affairs to Food and Drug Administration Office of Nonprescription Products re: Tylonol Arthritis Extended-Release Caplet and Geltab and Tylenol 8 hour Caplet Periodic Safety Update Report: Summary Bridging Report-March 1, 2008-February 28, 2009


D00002589 TYLNJ 03118887-88TYLNJ 06288994TYLNJ 06289054TYLNJ 06289058TYLNJ 06289060TYLNJ 06289235


D00002590 TYLNJ 02447690-91TYLREP01081640

11/5/2004 Letter from Lynn A Pawelski, Senior Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation Research regarding Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report: June 8, 2003-July 7, 2004

D00002591 TYLNJ 02447690-91TYLNJ 02447719

11/5/2004 Letter from Lynn A Pawelski, Senior Director, Regulatory Affairs to Food and Drug Administration Center for Drug

D00002592 TYLNJ 02447690-91TYLREP01437147TYLREP01081948

11/5/2004 Letter from Lynn A Pawelski, Senior Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation Research regarding Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report: June 8, 2003-July 7, 2004; Periodic Report 15 Day Alert Attached

D00002593 TYLNJ 02447691TYLNJ 00482587

11/5/2004 Letter from Lynn A Pawelski, Senior Director, Regulatory Affairs to Food and Drug Administration Center for Drug D00002594 TYLNJ 02447690-91

TYLNJ 0048256411/5/2004 Letter from Lynn A Pawelski, Senior Director, Regulatory

Affairs to Food and Drug Administration Center for Drug Evaluation Research regarding Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report: June 8, 2003-July 7, 2004; Periodic Report 15 Day Alert Attached

D00002595 TYLNJ 02447690-91TYLNJ 00482565

11/5/2004 Letter from Lynn A Pawelski, Senior Director, Regulatory Affairs to Food and Drug Administration Center for Drug D00002596 TYLNJ 06312015

TYLNJ 063120248/4/2005 Letter from John F. Hauser, Associate Director,Regulatory

Affairs to Food and Drug Administration Center for Drug Evaluation and Research re: Tylenol Arthritis ER Caplet Adverse Drug Experience Report: June 8, 2004-June 7, 2005

D00002597 TYLNJ 00503783 11/11/2004 Letter from McNeil Consumer & Specialty Pharmaceutical Pharmacovigilance Department to Food and Drug D00002598 TYLNJ 00170148

TYLREP01707987TYLNJ 01378753-58

3/22/2005 Johnson & Johnson Acetaminophen Periodic Safety Update Report December 1, 2003-January 31, 2005 and attachments

D00002599 TYLNJ 01462662-67 10/26/2005 Benefit Risk Management-Case Transmittal Draft for Triage Pilot and article faxed from Michele Rubincam at McNeil to BRM

D00002600 TYLNJ 01422966-68TYLNJ 01423004

7/21/2003 Fax from Sandra L. Schoenewald, PharmD to Eileen Geisinger regarding Tylenol Arthritis Pain ER Caplet and review and approval of attached submission to the FDA


D00002601 TYLNJ 03133424-25TYLNJ 06532667

8/6/2008 Letter from Eileen Geisinger, Associate Director, Global Regulatory Affairs to Dr. Leonard-Segal, Food and Drug Administration Office of Nonprescription Products re: Tylonol Arthritis Extended-Release Caplet and Geltab and Tylenol 8 hour Caplet Periodic Adverse Drug Experience Report June 8, 2007-June 7, 2008

D00002602 TYLNJ 03133424-25TYLNJ 06532787

8/6/2008 Letter from Eileen Geisinger, Associate Director, Global Regulatory Affairs to Dr. Leonard-Segal, Food and Drug Administration Office of Nonprescription Products re: Tylonol Arthritis Extended-Release Caplet and Geltab and Tylenol 8 hour Caplet Periodic Adverse Drug Experience Report June 8, 2007-June 7, 2008 with attachment

D00002603 TYLNJ 00185992TYLNJ 00186027TYLNJ 05362466TYLNJ 05362492

4/8/2009 Benefit Risk Management, Division of Johnson & Johnson Pharmaceutical Research and Development Paracetamol (Acetaminophen) Periodic Safety Update Report 9/1/08-2/28/09 Signed by Karel van Loon, Post Marketing Safety Franchise Leader, Office of Safety and Toxicology with an attached Executive Summary 3/1/07-2/29/08

D00002604 TYLNJ 00185992TYLNJ 00186004

Executive Summary 3/1/07-2/29/08

D00002605 TYLNJ 09293109-18 5/11/2007 Johnson & Johnson Benefit Risk Management Global AE Data Collection Form Fax from BRM to Redacted Patient with accompanying source documents

D00002606 TYLNJ 03133424-25TYLNJ 06532722TYLNJ 06532801


D00002607 TYLNJ 03133424-25TYLNJ 06532405


D00002608 TYLNJ 03133424-25TYLNJ 06532420



D00002609 TYLNJ 03133424-25TYLNJ 06532667


D00002610 TYLNJ 09293078-101 Adverse Event Files (Individual Case Safety Reports)

D00002611 TYLNJ 03133424-25TYLNJ 06532463


D00002612 TYLNJ 03133424-25TYLNJ 06532478


D00002613 TYLNJ 03133424-25TYLNJ 06532481


D00002614 TYLNJ 03133424-25TYLNJ 06532481


D00002615 TYLNJ 03133424-25TYLNJ 06532630



D00002616 TYLNJ 03133424-25TYLNJ 06532630


D00002617 TYLNJ 03133424-25TYLNJ 06532663


D00002618 TYLNJ 03133424-25TYLNJ 06532663


D00002619 TYLNJ 03133424-25TYLNJ 06532667



4/28/2011 Letter from Nadar Fotouhi, PhD, Associate Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation and Research, Office of Nonprescription Products regarding Tylenol Arthritis Pain 650 mg acetaminophen Extended Release Tablets and Tylenol 8 Hour Extended Release Tablets Periodic Safety Update Report: March 1, 2010-February 28, 2011




D00002622 TYLNJ 03133424-25TYLNJ 06532660


D00002623 TYLNJ 03133424-25TYLNJ 06532654


D00002624 TYLNJ 03133424-25TYLNJ 06532655


D00002625 TYLNJ 03133424-25TYLNJ 06532656











D00002630 TYLNJ 03118887-88 TYLNJ 06288994TYLNJ 06289821






D00002633 TYLNJ 03118887-88TYLNJ 06288994TYLNJ 06289056 TYLNJ 06289088-89TYLNJ 06289823




D00002635 TYLNJ 03118887-88TYLNJ 06288994TYLNJ 06289022TYLNJ 06289079-80TYLNJ 06289826







D00002638 TYLNJ 03118887-88TYLNJ 06288994TYLNJ 06289048 TYLNJ 06289087 TYLNJ 06289827













D00002652 TYLREP00588330TYLREP00588389

10/2/1995 Letter from Vivian A Chester, McNeil Executive Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation and Research re: submitting Adverse Drug Experience Report to NDA 17-552 covering the interval 7/23/94-7/22/95

D00002653 TYLNJ 09723428-36TYLNJ 04013432

1995-1996 Various letters and documents from 1995-1996 and associated documents

D00002654 TYLNJ 04196890TYLNJ 04196891TYLNJ 04196918TYLNJ 03437337TYLNJ 03437340

12/20/2000 Letter from McNeil (no second page for sender info) to Charles J. Ganley, MD, FDA, Director Division of OTC Drug Products Center for Drug Evaluation and Research re: Request for Acetaminophen Adverse Drug Experience Data Follow-up correspondence dated May 22, 2000; 15 Day Report Summaries McNeil Consumer Products Company First Quarter 1994

D00002655 TYLREP01054029TYLREP01054030TYLNJ 04194075TYLNJ 04194212

8/8/2000 Letter from Paula J. Oliver, Senior Director, Regulatory Compliance to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis Extended Relief Caplets Adverse Drug Experience Report 6/8/99-6/7/00

D00002656 TYLREP00603993-05 3/15/1994 Letter from Anthony R. Temple, MD, Executive Director, Medical Affairs to University of Texas Southwestern Medical Center regarding additional information needed for FDA Adverse Reaction Report forms

D00002657 TYLNJ 03437337TYLNJ 03437339TYLREP00603993

3/15/1994 Letter from Anthony R. Temple, MD, Executive Director, Medical Affairs to William M. Lee, MD, University of Texas Southwestern Medical Center regarding additional information needed for FDA Adverse Reaction Report forms

D00002658 TYLNJ 09250645-48TYLREP01001814TYLREP01001820


D00002659 TYLNJ 03437337-346TYLREP00616894

00/00/1994 15 Day Report Summaries, McNeil Consumer Product Company, First Quarter 1994


D00002660 TYLNJ 03941651TYLNJ 03941652TYLNJ 03941670


D00002661 TYLREP01001814TYLREP01001822


D00002662 TYLREP01001814TYLREP01001822


D00002663 TYLREP01001814TYLREP01001824


D00002664 TYLREP01409110TYLREP01409112TYLREP00787423TYLNJ 09724323TYLNJ 09724335TYLNJ 09724348TYLNJ 09724349

Undated Letter from Jeris P. Burnell, PharmD, McNeil, Medical Information Specialist, to unknown Redacted patient

D00002665 TYLNJ 03801077 9/16/1997 Letter from Douglas R. Hough, M.D., Director, Medical Affairs to Food and Drug Administration, Central Document Room regarding 15-Day alert ADE Reports Unknown Acetaminophen Product

D00002666 TYLNJ 06021571 4/28/2011 Letter from Nadar Fotouhi, PhD, Associate Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation and Research, Office of Nonprescription Products regarding Tylenol Arthritis Pain 650 mg acetaminophen Extended Release Tablet and Tylenol 8 hour 650 mg extended release tablet


4/28/2010 Letter from Nader Fatouhi, PhD, Associate Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis Pain 650 mg acetaminophen extended release tablets Periodic Safety Update Report-March 1, 2009-February 28, 2010


D00002668 TYLNJ 01213699TYLNJ 00677472

5/1/2003 Letter from McNeil Consumer & Specialty Pharmaceuticals Pharmacovigilance Department to Food and Drug Administration Central Document Room regarding 15-Day Alert ADE Report re: unspecified paracetamol product

D00002669 TYLNJ 09607329 3/10/1999 Letter from Douglas R. Hough, M.D., Director, Medical Affairs to Food and Drug Administration, Central Document Room regarding 15-Day alert ADE Follow up Report Unknown Tylenol Analgesic Product

D00002670 TYLNJ 04180420 4/25/2000 Letter from Sandra M. Lewis, PharmD, Medical Affairs Specialist to Syh-Jae Lin MD, Department of Pediatrics Chang Gung Children's Hospital regarding an article authored called "Acetaminophen Overdose in Children and Adolescents"

D00002671 TYLNJ 06311275TYLNJ 06311287


D00002672 TYLNJ 06311275TYLNJ 06311282


D00002673 TYLNJ 06311485TYLNJ 06311499

7/31/2002 Letter from Jacqueline U. Linse, Director, Global Submissions and CMC Regulatory to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report: June 8, 2001-June 7, 2002

D00002674 TYLNJ 06311676TYLNJ 06311701

8/1/2003 Letter from Paula J. Oliver, Senior Director, Regulatory Affairs, to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report 6/8/02-6/7/2003

D00002675 TYLNJ 06311676TYLNJ 06311700

8/1/2003 Letter from Paula J. Oliver, Senior Director, Regulatory Affairs, to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report 6/8/02-6/7/2003


7/16/1999 Letter from Douglas R. Hough, MD, Director Medical Affairs to Food and Drug Administration Central Document Room regarding 15-Day Alert ADE Follow-up Report Unknown Acetaminophen Product


D00002677 TYLNJ 00675976 3/21/2003 Letter from McNeil Consumer & Specialty Pharmaceutical, Pharcacovigilance Department to Food and Drug Administration Central Document Room regarding 15-Day Alert ADE Follow-Up Report

D00002678 TYLNJ 01232511 11/12/2002 Letter from McNeil Consumer & Specialty Pharmaceutical, Pharcacovigilance Department to Food and Drug Administration Central Document Room regarding 15-Day Alert ADE Follow-Up Report

D00002679 TYLNJ 04178917 6/30/2000 Letter from Joseph M Lynch, Director, Medical Affairs to Food and Drug Administration Central Document Room regarding 15-Day Alert ADE Report Unspecified Paracetamol Product


4/28/2011 Letter from Nadar Fotouhi, PhD, Associate Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation and Research, Office of Nonprescription Products regarding Tylenol Arthritis Pain 650 mg acetaminophen Extended Release Tablets and Tylenol 8 hour 650 mg acetaminophen extended release tablets Periodic Safety Update Report: March 1, 2010 - February 28, 2011

D00002681 TYLNJ 04177388 7/13/2000 Letter from Joseph M Lynch, Director, Medical Affairs to Food and Drug Administration Central Document Room regarding 15-Day Alert ADE Report Unspecified Paracetamol Product

D00002682 TYLNJ 04177259 1/7/2000 Letter from Joseph M Lynch, Director, Medical Affairs to Food and Drug Administration Central Document Room regarding 15-Day Alert ADE Report Unspecified Paracetamol Liquid

D00002683 TYLNJ 00676983 3/11/2003 Letter from McNeil Consumer & Specialty Pharmaceutical, Pharcacovigilance Department to Food and Drug Administration Central Document Room regarding 15-Day Alert ADE Report Unspecifiesd Paracetamol product

D00002684 TYLREP01001814TYLREP01001824


D00002685 TYLREP01001814TYLREP01001872



D00002686 TYLREP01001814TYLREP01001834


D00002687 TYLREP01002785-2786TYLREP01003164TYLREP01435261TYLNJ 04223630-631

9/6/2001 Follow up to correspondence requesting APAP ADR Data

D00002688 TYLREP00959987TYLREP00787444TYLNJ 04150157TYLNJ 09724276

10/29/1998 Letter from Paula J. Oliver, Senior Director, Regulatory Compliance, to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol E-S Tablets 500 mg Adverse Drug Experience Report 7/23/97-7/22/98

D00002689 TYLNJ 09724058 4/25/1997 Letter from Anthony R. Temple, MD, Executive Director Medical Affairs to Food and Drug Administration Central Document Room regarding 15-day alert ADE Follow-up Report Extra Strength Tylenol Product

D00002690 TYLNJ 09723445TYLNJ 09723444TYLNJ 09723443TYLNJ 09723442TYLNJ 09723441

5/22/1996 Letter from Thomas J. Mrazik, PharmD, McNeil Associate Director, Medical Affairs to Food and Drug Administration Center for Drugs and Biologics regarding 15-Day Alert ADE Report re: Extra Stregth Tylenol Gelcaps

D00002691 TYLNJ 01416068 7/1/1997 Chart of all Serious Reports for Single Ingredient Acetaminophen products Reported to FDA by McNeil from Jan 1996-November 1997

D00002692 TYLNJ 06311676TYLNJ 06311682

8/1/2003 Letter from Paula J. Oliver, Senior Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report June 8, 2002-June 7, 2003

D00002693 TYLNJ 06311676TYLNJ 06311710

8/1/2003 Letter from Paula J. Oliver, Senior Director, Regulatory Affairs to Food and Drug Administration to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report June 8, 2002-June 7, 2003

D00002694 TYLNJ 06311485TYLNJ 06311512



D00002695 TYLNJ 06311275TYLNJ 06311283

7/18/2001 Letter from Paula J. Oliver, Senior Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis Pain ER Caplet Adverse Drug Experience Report June 8, 2002

D00002696 TYLNJ 06311485TYLNJ 06311509


D00002697 TYLNJ 06311485TYLNJ 06311509



6/21/1999 Letter from Douglas R. Hough, M.D., Director, Medical Affairs to Food and Drug Administration, Central Document Room regarding 15-Day alert ADE Reports Unknown Acetaminophen Product


5/8/2003 Letter from McNeil Consumer & Specialty Pharmaceutical Pharmacovigilance Department to Food and Drug Administration regarding 15-Day Alert ADE Follow-Up Report Extra Strength Tylenol Caplets (unsigned letter)

D00002700 TYLREP01001814TYLREP01001820



D00002702 TYLNJ 04174689-91 6/26/2000 Letter from Anthony R. Temple, Vice President Medical Affairs to Food and Drug Administration Central Document Room Regarding 15-Day Alert Unknown Acetaminophen Product

D00002703 TYLNJ 00675861 1/28/2003 Letter from McNeil Consumer & Specialty Pharmaceutical Pharmacovigilance Department to Food and Drug Administration regarding 15-Day Alert ADE Follow-Up Report Extra Strength Tylenol Product (unsigned letter)

D00002704 TYLREP01001814TYLREP01001830



D00002705 TYLNJ 00675782 12/3/2002 Letter from McNeil Consumer & Specialty Pharmaceutical Pharmacovigilance Department to Food and Drug Administration regarding 15-Day Alert ADE Follow-Up Report acetaminophen 500 mg gelcaps (unsigned letter)

D00002706 TYLNJ 00676317 1/17/2003 Letter from McNeil Consumer & Specialty Pharmaceutical Pharmacovigilance Department to Food and Drug Administration regarding 15-Day Alert ADE Follow-Up Report Infants' Tylenol Drops (unsigned letter)



D00002708 TYLNJ 03941651TYLNJ 03941652TYLNJ 03941657TYLNJ 09250817TYLNJ 09250818TYLNJ 09250819




D00002710 TYLNJ 03941651-52TYLNJ 03941657


D00002711 TYLNJ 03941651-52TYLNJ 03941660


D00002712 TYLNJ 06311485TYLNJ 06311499



D00002713 TYLNJ 06311485TYLNJ 06311497


D00002714 TYLREP01001814TYLREP01001822


D00002715 TYLNJ 03801762 7/10/1997 Letter from Anthony R. Temple, MD Executive Director Medical Affairs to Food and Drug Administration Central Document Room Center for Drugs and Biologics regarding 15-Day Alert ADE Report Extra Strength Tylenol Caplets

D00002716 TYLNJ 09266214 No date ADE Report Record




4/28/2010 Letter from Nader Fatouhi, PhD, Associate Director, Regulatory Affairs to Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis Pain 650 mg acetaminophen extended release tablets and Tylenol 8 hour 650 mg acetaminophen extended release tablets Periodic Safety Update Report-March 1, 2009-February 28, 2010






D00002728 TYLNJ 08725165TYLNJ 09294334TYLNJ 06280913TYLNJ 06287442TYLNJ 06287450TYLNJ 06281775

















D00002742 TYLNJ 06299744TYLNJ 06301210

4/18/2011 PSUR Update













4/26/2012 Letter from Eileen Harman, Associate Director of Regulatory Affairs to Andrea Leonard-Segal, M.D. Director of FDA, Office of Drug Evaluaton IV re: Tylenol Arthritis Pain Extended-Release Tablet 650 mg and Tylenol 8 Hour Extended Release Tablet 650 mg Periodic Safety Update Report: March 1, 2011-February 29, 2012





















7/30/2013 Letter from Eileen Harman, Associate Director, Regulatory Affairs to Shaw Chen, MD, PhD, Acting Director, Food and Drug Administration Center for Drug Evaluation and Research regarding Tylenol Arthritis 8 hour extended release tablet, Tylenol 8 hour extended release tablet Periodic Benefit Risk Evaluation Report/Periodic Safety Update Report: June 1, 2012-May 31, 2013



7/24/2012 Letter from Eileen Harman, Associate Director of Regulatory Affairs to Andrea Leonard-Segal, M.D. Director of FDA, Office of Drug Evaluaton IV re: Tylenol Arthritis Pain Extended-Release Tablet and Tylenol 8 Hour Extended Release Tablet Periodic Safety Update Report: Summary Bridging Report March 01, 2012- May 31, 2012


7/24/2012 Letter from Eileen Harman, Associate Director of Regulatory Affairs to Andrea Leonard-Segal, M.D. Director of FDA, Office of Drug Evaluaton IV re: Tylenol Arthritis Pain Extended-Release Tablet and Tylenol 8 Hour Extended Release Tablet Periodic Safety Update Report: Summary Bridging Report March 01, 2012- May 31, 2012


















D00002798 3/00/2009 WHO Model List of Essential Medicines, 16th Edition, March 2009


D00002800 4/00/2002 WHO Model List of Essential Medicines, 12th Edition, April 2002



D00002803 4/00/2013 WHO Model List of Essential Medicines for Children, 4th Edition, April 2013


D00002804 Scientific Registry of Transplant Recipients: Adj. Patient Survival, Deceased Donor Liver Transplants - Survival at 3 Months, 1 Year, 5 Years, and 10 Yearshttp://www.srtr.org/annual_reports/2011/912a_li.pdf

D00002805 AIDS Infonet. Normal laboratory values. Fact Sheet 120A, revised April 26, 2007. http://www.aidsinfonet.org/fact_sheets/view/120

D00002806 6/8/2009 Addendum to FDA Background Package for June 29-30, 2009 Meeting: Summary of Studies Reporting on Pack Size Limits in the United Kingdom, June 8, 2009

D00002807 7/1/2009 Addendum Johnson & Johnson Briefing Document, July 1, 2009

D00002808 6/29/2009 Rocky Mountain Poison and Drug Center June 29, 2009 FDA Presentation

D00002809 6/8/2009 Briefing Document for FDA Advisory Committee Meeting, June 8, 2009

D00002810 7/8/1977 42 Fed Reg 35146

D00002811 11/16/1988 53 Fed Reg 46215

D00002812 11/16/1988 53 Fed Reg 46217

D00002813 7/8/1977 42 Fed Reg 35412

D00002814 4/29/2009 74 Fed Reg 19396-98

D00002815 9/24/1984 Public Law 98-417; Hatch Waxman Act

D00002816 TYLNJ 08680126 6/24/2010 FDA Public Workshop - McNeil Presentation on Improving Patient's Awareness of APAP in OTC and Rx Medicines

D00002817 TYLNJ 07782288-91 Preliminary FDA Response for Industry Meeting

D00002818 TYLNJ 08515365-66 12/12/2012 Email from Milton Linn to Julie Copaken re FDA icon meeting

D00002819 TYLNJ 07782383-84 12/12/2012 Email from Vicki Wagner-Weber regarding FDA icon meeting

D00002820 TYLNJ 07790821-22 12/10/2012 Email from Christina Jessurun to Barbara Kochanowki regarding icon meeting preliminary comments

D00002821 TYLNJ 04334748 7/16/2009 Email from Barbara Kochanowski regarding 7/22 APAP Task Group Meeting Summary

D00002822 TYLNJ 07134227-30 Acetaminophen 500 mg is generally well tolerated with a safety profile consistent with other acetaminophen products

D00002823 TYLNJ 07175901-28 Adverse Event Reporting Procedure Manual

D00002824 TYLNJ 07116575-76 Draft AERS data review for the period of 2000 through September 2011

D00002825 TYLNJ 07163673-79 10/10/2012 Email from Sandra Schoenewald to Andrew Myers regarding AERS query

D00002826 TYLNJ 07088860 5/15/2012 Power Point regarding AERS review (draft)

D00002827 TYLNJ 02807933-44 Hepatic Case Review

D00002828 TYLNJ 05989320 11/7/2005 Memo from Sandy Schoenewald to Pete Shindel regarding AERs


D00002829 TYLNJ 02672794-97 Draft Post-marketing Overview

D00002830 TYLNJ 10776706-07 4/14/2011 Inspection Report

D00002831 TYLNJ 04756887-89 MedWatch 20100607442

D00002832 TYLNJ 04756942-44 MedWatch 20100607885

D00002833 TYLNJ 04756997-7000 MedWatch 20100608007

D00002834 TYLNJ 04757005-8 MedWatch 20100608015

D00002835 TYLNJ 04757272-75 MedWatch 20100800606

D00002836 TYLNJ 06367801-03 MedWatch 20100600241

D00002837 2/11/2009 74 Fed Reg 6823-24

D00002838 2/11/2009 74 Fed Reg 6896-6901



D00002841 00/00/1997 WHO Drug Information, Volume 11, Number 2, 1997

D00002842 11/00/2000 CDER-PhRMA-AASLD Conference 2000; Clinical White Paper

D00002843 UTSMC-00208-504 William Lee Production Documents

D00002844 5/9/2014 FDA Safe Use Initiative

D00002845 6/5/2014 FDA Safe Use Initiative; Collaborating to Reduce Preventable Harm from Medications

D00002846 00/00/2014 21 CFR 314.81

D00002847 TYLNJ 01216704-7030 6/16/1993 McNeil 1993 OTC Drugs Advisory Committee meeting submission

D00002848 TYLNJ 06671840-50 Audit Report with CAPP Responses

D00002849 9/19/2002 Safety Analysis of APAP-Associatee Hepatotoxicity Office of Drug Safety Analysis

D00002850 TYLNJ 10776689-705 2/12/2013 Correspondence from Kirk Sooter to Amrit Jay regarding Establishment Inspection Report

D00002851 TYLNJ 10776708-17 4/29/2011 Correspondence from Amrit Ray to Kirk Sooter regarding April 14, 2011 483

D00002852 TYLNJ 10776718-19 5/6/2011 Correspondence from Kirk Sooter to Amrit Jay regarding April 29, 2011 letter

D00002853 NJTYL_TEMPLE_CV Anthony Temple Curriculum Vitae

D00002854 TYLNJ 03283961-65 Summary of Studies Examining Consumer Use of Acetaminophen

D00002855 TYLNJ 02642994-3393 12/14/2000 McNeil Consumer Healthcare Clinical Study Report for Protocol 96-619:A Phase IV, Randomized, Double-Blind, Multicenter Trial to Compare the Safety and Efficacy of Acetaminophen and Ibuprofen Suspension in the Treatment of Febrile Children. CSR 257

D00002856 TYLNJ 01174714-4839 12/14/2000 McNeil Consumer Healthcare Clinical Study Report for Protocol 96-608: A Single-Dose, Randomized, Double-Blind Trial to Compare the Efficacy and Safety of Ibuprofen Suspension 7.5 mg/kg With Acetaminophen Suspension 12.5 mg/kg for the Treatment of Febrile Children. CSR 256


D00002857 7/21/1972 37 Fed Reg 14591-606

D00002858 TYLNJ 03957303-7399 12/10/1993 McNeil Consumer Healthcare Clinical Study Report for Protocol 93-329: A Phase III Combined Study of Efficacy and Side Effects Profile of Extended Release Acetaminophen Pediatrict Chewable Tablets Compared to Acetaminophen 8-Hour Extended Release Pediatric Suspension in the Treatment of Febrile Children. CSR 194

D00002859 TYLNJ 03562992-3031 5/13/1997 McNeil Consumer Healthcare Clinical Study Report for Protocol 95-516: A Single-Dose, Randomized, Investigator-Blinded Trial to Compare the Efficacy and Safety of Ibuprofen Suspension 7.5 MG/KG with Acetaminophen Suspension 12.5 MG/KG for the Treatment of Febrile Patients. CSR 226

D00002860 TYLNJ 03588401-8482 00/00/1997 A Phase III Study Comparing the Efficacy and Pharmacokinetic/pharmacodynamic profile of acetaminophen extended release suspension, 1997 acetaminophen extended release chewable tablets, and acetaminophen elixir in febrile children. CSR 195S.

D00002861 TYLNJ 03764497-4559 12/19/1994 McNeil Consumer Healthcare Clinical Study Report for Protocol 93-341: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. CSR 196

D00002862 TYLNJ 01176020-6143 2/10/1997 A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Suspension Compared to Children's Tylenol Elixir in the Treatment of Febrile Children

D00002863 TYLNJ 04201445-1475 12/22/1997 McNeil Consumer Healthcare Supplemental Clinical Study Report for Protocol 90-056: The Safety of Antipyretic Medication Use Among Children Less Than Two Years of Age: A Subgroup Analysis of the Boston University Fever Study Data

D00002864 TYLNJ 06009467-9547 8/8/1996 McNeil Consumer Healthcare Clinical Study Report for Protocol 94-437: A Single Dose, Randomized, Investigator-Blinded Trial to Compare the Efficacy and Safety of Ibuprofen Suspension 7.5 MG/KG with Acetaminophen Suspension 12.5 MG/KG for the Treatment of Febrile Children. CSR 214

D00002865 TYLNJ 03957137-7239 12/30/1994 A single dose study to compare the efficacy of acetaminophen sustained release pediatric chewable tablets to ibuprofen suspension in febrile children. CSR 190.


D00002866 TYLNJ 01220973-1035 12/19/1994 McNeil Consumer Healthcare Clinical Study Report for Protocol 93-341: A Phase III Multiple Dose Use Study of APAP Extended Release Pediatric Chewable Tablets Compared to Children's Tylenol Chewable Tablets in the Treatment of Febrile Children. CSR 196

D00002867 TYLNJ 01175560-5995 12/22/1993 An Assessment of the Safety of Pediatric Ibuprofen (Boston University Fever Study)

D00002868 TYLNJ 03765925-6045 12/18/1992 McNeil Consumer Healthcare Clinical Study Report for Protocol 90-002 & 90-003: A Comparison of the Efficacy and Safety of Ibuprofen Dosed at 5 MG/KG and 10 MG/KG and Acetaminophen Elixir Dosed at 12.5 MG/KG to Placebo in Children with Ear Pain. CSR 151

D00002869 TYLNJ 01076014-6065 12/18/1992 McNeil Consumer Healthcare Clinical Study Report for Protocol 89-949 & 90-001: A Comparison of the Efficacy and Safety of Ibuprofen Suspension Dosed at 5 MG/KG and 10 MG/KG and Acetaminophen Elixir Dosed at 12.5 MG/KG to Placebo in Children With Sore Throat Pain

D00002870 TYLNJ 05757998-8039 2/7/1992 McNeil Consumer Healthcare Clinical Study Report for Protocol 89-945: A Single Dose Study to Compare the Efficacy of Acetaminophen Elixir Dosed at 10-15 MG/KG and Ibuprofen Suspension Dosed at 5 MG/KG and 10 MG/KG in Febrile Children:

D00002871 TYLNJ 03760875-0884 10/14/1991 McNeil Consumer Healthcare Clinical Study Report for Protocol 89-932: A Single Dose Study to Compare the Efficacy of Acetaminophen Elixir Dosed at 12.5 MG/KG and 25 MG/KG and Ibuprofen Suspension Dosed at 5 MG/KG and 10 MG/KG in Febrile Children. CSR 149

D00002872 TYLNJ 01303418-3446 8/16/1988 A dose range study of the antipyretic efficacy and safety of ibuprofen pediatric suspension in febrile children. CSR 162.

D00002873 TYLNJ 03956886-6947 3/1/1990 McNeil Consumer Healthcare Clinical Study Report for Protocol 88-845: A Study of the Efficacy and Side Effects Profile of Sustained Release Acetaminophen Pediatric Chewable Tablets Compared to Children's Tylenol® Chewable Tablets in the Treatment of Febrile Children. CSR 120.

D00002874 TYLNJ 03956800-6857 1/29/1990 McNeil Consumer Healthcare Clinical Study Report for Protocol 88-813: A Randomized, Investigator Blinded, Parallel, Single Dose, Multicenter Study to Compare for Eight Hours The Efficacy and Side Effects Profile of Sustained Release Acetaminophen Pediatric Chewable Tablets (20-30 MG/KG) Compared to Regular Strength, Conventional Release Acetaminophen Pediatric Chewable Tablets (10-25 MG/KG) in the Treatment of Febrile Children. CSR 117.


D00002875 TYLNJ 01177496-7549 6/2/1989 McNeil Consumer Healthcare Clinical Study Report for Protocol 86-642: A Randomized, Open Label, Parallel, Single Dose Study of the Antipyretic Efficacy, Safety, and Blood Levels of Ibuprofen 6 MG/KG in Febrile Children with Acetaminophen 10-15 MG/KG as a Positive Control for Efficacy.

D00002876 TYLNJ 01177550-7598 2/22/1988 McNeil Consumer Healthcare Clinical Study Report for Protocol 6-640: A Multiple Dose Study Comparing the Antipyretic Efficacy and Safety of 5 - 7 mg/kg of Ibuprofen and 10 - 15 mg/kg of Acetaminophen in Febrile Children. Stat. Rpt. 85

D00002877 TYLNJ 01177469-7495 2/4/1988 McNeil Consumer Healthcare Clinical Study Report for Protocol 5-535: A Single Dose Double-Blind Study Comparing the Efficacy of Ibuprofen and Children's Tylenol Elixir. Stat. Rpt. 80

D00002878 TYLNJ 01175501-5547 1/15/1988 McNeil Consumer Healthcare Clinical Study Report for Protocol 6-639: A Comparative Dose Range Evaluation of the Antipyretic Efficacy and Safety of Ibuprofen Liquid at Three Different Doses in Children. Stat. Rpt. 84

D00002879 TYLNJ 03567521-7550 6/11/1986 A Statistical Report on Protocol 0-220: A Double-Blind Multiple Dose Study of the Comparative Antipyretic Effectiveness and Safety of Standard and Double Standard Doses of Acetaminophen in Febrile Children. Stat. Rpt. 65

D00002880 TYLNJ 01177637-7652 1/26/1984 McNeil Consumer Healthcare Clinical Study Report for Protocol 2-222: A Phase III Double-Blind, Single Dose Study of the Comparative Antipyretic Effectiveness and Safety of Standard and Double Standard (C-47) Doses of Acetaminophen in Febrile Chilren. Stat. Rpt. 48

D00002881 TYLNJ 03772057-2060 3/16/1983 Summary of the Interim Analysis of the Double-Blind Study Comparing the Effectiveness of 10 mg/kg and 20 mg/kg of Acetaminophen vs. Placebo in Moderating Reactions to D.P.T. Immunizations. Protocol #1-227.

D00002882 TYLNJ 01175548-5559 8/27/1982 A Phase IV Double-Blind Multicenter Study Comparing the Antipyretic Effectiveness of Aspirin, Acetaminophen and Placebo in Febrile Children. Protocol #9-106. (Amended). CPC Statistical Report #32.

D00002883 TYLNJ 01210942-0951 6/8/1981 An Evaluation of the Efficacy and Safety of C-14 Elixir in Pediatric Patients With Symptomatology Requiring an Analgesic and/or Antipyretic. Stat. Rpt. 17

D00002884 TYLNJ 03982969-2973 00/00/1981 A Statistical Report on Protocol 79-106: A Phase IV Double-Blind Multicenter Study Comparing the Antipyretic Effectiveness of Aspirin, Acetaminophen, Choline Salicylate and Placebo in Febrile Children. Stat. Rpt. 16


D00002885 TYLNJ 09764470-4479 3/23/1981 An Evaluation of the Efficacy and Safety of C-9-7 Cold Formula in Pediatric Patients with Symptomatology of Upper Respiratory Infection or Allergic Rhinitis. Stat. Rpt. 13

D00002886 TYLNJ 06539494-9500 11/15/1978 Phase IV Efficacy and Safety Study of Reformulated CoTylenol Tablets. Stat. Rpt. 5

D00002887 TYLNJ 03427507-7508 12/28/1978 Interim Statistical Analysis of the Study of the Bioavailability and Antipyretic Effectiveness of Acetaminophen in Children. Stat. Rpt. 7

D00002888 TYLNJ 09224064-67

10/29/2013Email from Scott Monks to Cheryl Sikolia re: Extra Strength Tylenol NDC 488-499 – Confirmation no longer being made

D00002889 1/15/2002 Memorandum from Rosemarie Neuner to Charles Ganley regarding An Archeological Review of the Regulatory History of Over-the-Counter (OTC) Single Ingredient Acetaminophen

D00002890 TYLNJ 01279579-861 4/15/2002 McNeil's Case Assessment Conference with Expert panel

D00002891 TYLNJ 01809457-58 3/26/2004 Correspondence from Debra Bowen regarding APAP plus NAC

D00002892 TYLNJ 03396305-11 8/15/1986 Memo from Thomas Gates regarding methionine/APAP formulation

D00002893 TYLNJ 03396311 Paracetamol/methionine combination being developed for OTC market

D00002894 TYLNJ 03396350 11/2/1993 Memo from Pat Stewart to Ralph Levi regarding BTG/Penn Pharmaceuticals

D00002895 TYLNJ 03477657 11/6/1992 Correspondence from Ralph Levi to Don Collela regarding APAP-Methionine

D00002896 TYLNJ 03478102-03 4/8/1993 Correspondence from Paul Mollet to Dr. Brugmans regarding Roger Jones

D00002897 TYLNJ 03740259-60 7/25/1994 McNeil memo regarding Project Protect Recommendations

D00002898 TYLNJ 03740425 6/28/1994 Correspondence from Robert Havard to John F. Ritter regarding organo-sulfur compounds

D00002899 TYLNJ 03740858 2/15/1995 Correspondence from Robert Havard to Patricia Stewart regarding licensing arrangment for Rutgers and funding for Dr. Yang

D00002900 TYLNJ 03741199-1200 11/4/1992 Correspondence from Donald Colella of British Technology Group USA to Robert Havard regarding BTG USA

D00002901 TYLNJ 03829408-12 1/3/1995 Letter from Chung Yang to Patricia Stewart regarding possible future interactions

D00002902 TYLNJ 04032219-20 Project Protect memo

D00002903 TYLNJ 04032221 10/7/1992 Correspondence from Anthony Temple to Elliot Piperno regarding agreement to retain as consultant

D00002904 TYLNJ 04273756-57 7/17/1973 Correspondence from P. H. Seah regarding Tylenol tablet


D00002905 TYLREP00541189 4/20/1993 Correspondence from J. Brugmans to Ralph Levi regarding methionine/acetaminophen combination patent

D00002906 TYLREP00541225-26 4/8/1993 Correspondence from Paul Mollet to Dr. Brugmans regarding Roger Jones

D00002907 TYLREP00541277 11/9/1992 Memo to file from Ralph Levi regarding APAP/methionine

D00002908 TYLREP00541288 11/2/1992 Correspondence from Jean B. Eble to Ralph Levi regarding APAP THIO AMINO ACID Combination

D00002909 TYLREP00541785 2/2/1994 Correspondence from Jean B. Eble to Gail Buehler regarding APAP/methionine

D00002910 TYLREP00578695-97 3/3/1995 Memo from Edward Nelson regarding Project Protect Meeting on 1/27/95

D00002911 TYLREP00621488-89 1/27/1994 Correspondence from Anthony Temple to William Lee regarding case reports in New England Journal of Medicine article

D00002912 TYLREP00622834-839 1/31/1995 Testimony of Laura Grasso on behalf of the American Liver Foundation

D00002913 TYLREP00622942-3011 5/8/1995 Letter from Anthony Temple enclosing 8/9/1994 Submission to the OTC Drugs Advisory Committee

D00002914 TYLREP00623047-53 4/13/1995 Memo from Alan Brownstein to Anthony Temple re: policy statement on acetaminophen

D00002915 00/00/1994 Darvocet-N 100 labelD00002916 TYLREP00168736-976 00/00/1992 Tylenol Extra Strength Capsules, NDA 17-053,

Correspondence, Vol. 1 of 1

D00002917 TYLNJ 04317804-8063 5/17/1988 Regulatory Copy, APAP SR Caplet, 650mg, NDA 19-872, Vol. 1 of 2

D00002918 TYLNJ 09565008 00/00/2007 Tylenol Print AdTYLEPM-0853

D00002919 TYLNJ 05443389-4060 9/7/2011 A single-center, randomized, double-blind, placebo-controlled, single-dose, safety and efficacy study of acetaminophen 1000mg and acetaminophen 650mg in postoperative dental pain

D00002920 A phase IV double-blind, single dose study of the safety and efficacy of acetaminophen 100mg, Gemnisyn 1300mg, and lacebo in the treatment of pain following oral surgery

D00002921 A double-blind, single dose evaluation of the relative analgesia and safety of acetaminophen 200mg, 1500mg,1000mg, 500mg, and placebo in the treatment of pain following oral or periodontal surgery

D00002922 A phase IV double-blind single dose evaluation of the safety and efficacy of acetaminophen 1000mg, aspirin 650mg, and placebo in the treatment of pain following oral surgery


D00002923 A pilot-evaluation of the analgesic efficacy and adverse effect liability of acetaminophen 1000mg and placebo in the treatment of pain following oral surgery

D00002924 A double-blind, single-dose evaluation of the efficacy and safety of ibuprofen 400mg, ibuprofen 200mg, APAP 1000mg, and placebo in the treatment of pain following removal of impacted third molars

D00002925 A double-blind, single dose evaluation of the comparative efficacy of acetaminophen 1000mg, ibuprofen 200mg, ibuprofen 400mg, and placebo in the treatment of pain following periodontal surgery

D00002926 A double-blind, single dose evaluation of the efficacy and safety of acetaminophen 1000mg, ibuprofen 400mg, and placebo in the treatment of pain following oral surgery

D00002927 TYLNJ 02571444-1750TYLNJ 05749057-9100

9/8/2009 A randomized, double-blind, placebo-controlled, single-dose, parallel-group study of acetaminophen 1000mg/diphenhydramine HCI 50mg on subjects post-oral surgery with phase-shifted sleep

D00002928 TYLNJ 05881831-1839 10/16/2008 A proof-of-concept evaluation of the dental pain model to assess efficacy of acetaminophen 1000mg/diphenhydramine HCI 50mg

D00002929 TYLNJ 02594523-4865 9/22/2008 A Single-Center, Open-Label, Cross-Over Study to Evaluate the Esophageal Transit Time of Tylenol Arthritis 650mg Geltabs Compared to Tylenol Arthritis 650mg Tablets with Filmcoat in Men and Women 65 years and older

D00002930 TYLNJ 02549894-9989 A comparison of the extent and duration of the analgesic properties of acetaminophen and ibuprofen when given alone and in three varied ratio combinations-A randomized, placebo-controlled, single-blind 6 sequence, infra-individual crossover study-using

D00002931 MURPHY 00191870-1971 A comparison of the extent and -duration of the analgesic properties of single-dose acetaminophen (APAP), ibuprofen (IBU), ketorolac (KETO), and a combination of APAP, codeine, caffeine (ACOCA)- In a randomized, placebo- controlled, single-blind, 6-sequence, intra-individual crossover study-Using Laser somatosensory evoked potentials (LSEPs) and Visual Analogue Scales (VAS Pain) - obtained from UV-irritated (hyperalgesic) skin in healthy


D00002932 A comparison of the extent and duration of the analgesic properties of single-dose acetaminophen (APAP), ibuprofen (IBU), ketorolac (KETO), and a combination of APAP, codeine, caffeine (ACOCA)- In a randomized, placebo-controlled, double-blind, 4 sequence intra-individual crossover study- Using a

D00002933 MURPHY 00192100-2198 A comparison of the extent and duration of analgesic properties of acetaminophen and ibuprofen when given alone and in various dose combinations-A randomized, placebo-controlled, double-blind 6 sequence crossover study-Using laser somatosensory evoked potentials (LSEPs) and Visual Analogue Scales (VAS) - obtained from UV(B)-irritated skin in healthy volunteers

D00002934 TYLNJ 03014551-4653 11/28/2006 Bioavailability of acetaminophen from two formulations of acetaminophen calcium relative to both extra strength Tylenol adult liquid and caplets

D00002935 Comparison of absorption time between liquid-filled ibuprofen capsules and solid acetaminophen caplets

D00002936 TYLNJ 01008316-8719 7/9/2004 A Randomized, Double-blind, Parallel-Group Study Comparing the Safety and Efficacy of Acetaminophen Extended Release (3900mg/day) and Ibuprofen (1200mg/day) in the Treatment of Ankle Sprains

D00002937 TYLNJ 01545153-5624TYLNJ 04665898-6368

5/27/2005 Effect of Analgesics on the Irreversible Inactivation of Cyclooxygenase-1 Activity by Low Dose Aspirin and Endoscopic Evaluation of the Gastric Mucosal Effect

D00002938 TYLNJ 02581032-1240 Tolerability and Multiple-Dose Pharmacokinetics of Acetaminophen (Paracetamol) at and above the currently recommended dose

D00002939 TYLNJ 02580683-1023 Effect of OTC Analgesics on the Irreversible Inactivation of COX-1 Activity by Low-Dose Aspirin

D00002940 TYLNJ 01540368-1388TYLNJ 04665015-5894

7/12/2005 A Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Acetaminophen Extended Release (3900mg/day) in the treatment of Osteoarthritis of the hip and knee

D00002941 A comparison of the extent and duration of analgesic/anti-hyperalgesic properties of acetaminophen and diphenhydramine when given alone and in combination-A randomized, placebo-controlled, double-blind, 4 sequence crossover study-Using Laser somatosensory

D00002942 TYLNJ 0437990-8096 A comparison of the extent and duration of analgesic properties of acetaminophen and ibuprofen when given alone and in various combinations-A randomized, placebo-controlled, double-blind 6 sequence crossover study-Using laser somatosensory evoked potential


D00002943 TYLREP 0824688-692TYLNJ 00585475-515

9/1/2004 Bioequivalence pilot study of three test formulations of extended-release acetaminophen geltabs and tylenol arthritis extended relief caplets

D00002944 TYLNJ 06213361-3409 A pharmacokinetics study of diphenhydramine following dosing of liquid diphenhydramine HCI and tylenol PM gelcaps

D00002945 TYLNJ-01538261-01540367 4/7/2005 A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (1950mg/day and 3900mg/day) in the treatment of osteoarthritis of the hip of knee

D00002946 TYLNJ 02588093-8394 A Single-Dose, Double-Blind, Placebo-Controlled Study of the Relative Efficacy and Safety of Acemtainophen at Doses of 500mg and 1000mg in Postoperative Dental pain

D00002947 TYLNJ 01515896-6766 A Four Week Comparative Study Evaluating Actaminophen Extended Release (3900mg/day) and Rofecoxib (12.5mg/day 2.5mg/day) in the Treatment of Osteoarthritis of the knee

D00002948 TYLNJ 01007966-8184 8/3/2004 A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Parallel Group Study of Acetaminophen 1000mg and Ibuprofen 400mg in Postoperative Dental Pain

D00002949 TYLNJ 01009078-9568 8/26/2004 A Randomized, Double-Blind, Placebo-Controlled Study evaluating acetaminophen extended -release caplets (3900mg/day) in the treatment of post-race muscle aching and pain (sorenessO

D00002950 TYLNJ 01269954-0198 Bioequivalence of Acetaminophen from red Acetaminophen Extended Release Caplets, 650mg vs. Tylenol Arthritis Pain Extended Relief caplets in Healthy adults

D00002951 TYLNJ-01546108-7935 2/9/2005 A Randomized, Double-Blind, Long-Term Comparative Study Evaluating the Safety and Efficacy of Acetaminophen (4000mg/day) and Naproxen 750mg/day) in the Treatment of Osteoarthritis of the hip or knee

D00002952 TYLNJ 02527761-7808 11/23/2004 Comparison of early acetaminophen absorption from teal acetaminophen gelcaps and extra strength tylenol gelcaps

D00002953 TYLNJ 01009078-9568 A Randomized, Double-Blind Study Evaluating Acetaminophen Extended Release Caplets (3900mg/day) and Ibuprofen (1200mg/day) in the Treatment of Post-Race Muscle Soreness

D00002954 TYLNJ 01010137-0665 7/16/2004 A Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Varying Doses of Acetaminophen on International Normalized Ratio (INR) Stability in Subjects Receiving Therapeutic Warfarin


D00002955 TYLNJ 02549688-9794 9/22/2005 A comparison of the extent and duration of analgesic properties of acetaminophen and ibuprofen when given alone and in various dose combinations-A randomized, placebo-controlled, double-blind 4 sequence crossover study-Using laser somasensory evoked potentials

D00002956 TYLNJ 04379990-0096 9/22/2005 A comparison of the extent and duration of analgesic properties of acetaminophen and ibuprofen when given alone and in various dose combinations-A randomized, placebo-controlled, double-blind 6 sequence crossover study-Using laser somasensory evoked potential (LSEPs) obtained from capsacin irritated skin in healthy volunteers

D00002957 TYLNJ 06330562-0874 Bioequivalence Determination of Extra Strength Tylenol Gelcaps and Caplets with Extra Strength Tylenol tablets

D00002958 TYLNJ 01080807-0903 1/11/2000 A randomized, double-blind parallel clinical study comparing the analgesic efficacy and safety of acetaminophen, naproxen sodium, ibuprofen, and aspirin in patients with osteoarthritis. CSR 228

D00002959 TYLNJ 04185986-6276 12/20/2000 A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Acetaminophen 1000mg for the Treatment of Migraine Headache Pain

D00002960 TYLNJ 01070800-0961 12/20/2000 A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Acetaminophen 1000 mg for the Treatment of Migraine Headache Pain.

D00002961 TYLNJ 01071090-1243 12/20/2000 A single-dose, randomized, double- blind, placebo-controlled study evaluating the efficacy and safety of acetaminophen 1000 mg for the treatment of migraine headache pain.

D00002962 TYLNJ 04192430-2485 A pilot comparative study evaluating the analgesic effect of using a single dose of an ibuprofen 200mg/acetaminophen 650mg combination or ibuprofen 400mg in post-operative dental pain.

D00002963 TYLNJ 01930084-0091 12/14/2000 A phase IV comparative study of the safety and efficacy of acetaminophen versus naproxen sodium in the treatment of osteoarthritis of the knee with endoscopic evaluation of the gastric and duodenal mucosal effects

D00002964 TYLNJ 00668690-8877 12/15/2000 A randomized, double-blind, double-dummy, single-center pilot study of the speed of onset of analgesia of extra strength tylenol adult liquid (1000 mg) compared with extra strength tylenol caplet (1000 mg) in post-operative dental pain. (CSR-260)


D00002965 TYLNJ 015347799-5063TYLNJ 06179829-9895

A randomized, double-blind, placebo-controlled, double-dummy study evaluating the analgesic effect of a single dose ofacetaminophen 1000 mg or •celecoxib 100 mg in postoperative dental pqin. (CSR-251)

D00002966 TYLNJ 01076550-6804 12/14/2000 A randomized, double-blind, triple- dummy, placebo-controlled study evaluating the analgesic effect of using a single dose of acetaminophen 1000 mg, celecoxib 100 mg or ibuprofen 400 mg in ppostoperative dental pain. (CSR- 252)

D00002967 TYLNJ 01077885-7976 8/5/1999 Effects of an acetaminophen- diphenhydramine combination on sleep in subjects with pain secondary to osteoarthritis. CSR 218.

D00002968 TYLNJ 04097462-7533 2/9/1999 Effects of acetaminophen- diphenhydramine combination on sleep in subjects with pain secondary to osteoarthritis as determined by out-patient EEG monitoring. CSR 221(R1).

D00002969 BOKA 000027524-27588 7/22/1999 Evaluation of the efficacy and safety of tramadol/APAP in oral surgical pain.

D00002970 BOKA 000027589-27649 7/22/1999 Evaluation of the efficacy and safety of tramadol/APAP in oral sugical pain.

D00002971 BOKA 000027365-27430 7/22/1999 Evalaution of the efficacy and safety of tramadol/APAP in oral surgical pain.

D00002972 TYLNJ 02518568-8753 A factorially-designed analgesic efficacy study comparing combinations of acetaminophen in doses of 325 mg, 500 mg, and 1000 mg and dextromethorphan hydrobromide in doses of 5 mg, 15 mg, and 30 mg, with the components alone and placebo in post-operative d

D00002973 TYLNJ 06330875-1393 7/30/1982 A comparative study evaluating the analgesic efficacy of a single dose of acetaminophen 1000 mg, acetaminophen 1000 mg/dextromethorphan hydrobromide 30 mg, ibuprofen 400 mg, dextromethorphan hydrobromide 30 mg, or placebo in post-operative dental pain. C

D00002974 TYLNJ 06331452-1547 6/12/1998 A comparative study using a single dose of acetaminophen, acetaminophen/tramadol hydrochloride, tramadol hydrochloride alone, and placebo in the treatment of post-operative dental pain. CSR 229 R1.

D00002975 TYLNJ 04149738-9829 6/10/1998 A phase III comparative study using a single dose of acetaminophen, acetaminophen/cyproheptadine, cyproheptadine alone, and placebo in the treatment of migraine headache. CSR 219.


D00002976 TYLNJ 06180191-0263 6/17/1998 Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002- AQ-22) in gynecological surgical pain.

D00002977 BOKA 000027651-27700 1/23/1998 Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002- AQ-22) in oral surgical pain.

D00002978 BOKA 000027327-27363 2/10/1998 Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002- AQ-22) in oral surgical pain.

D00002979 TYLNJ 04253576-3586TYLNJ 06180264-0318

Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002- AQ-22) in orthopedic surgical pain (Protocol TRAMAP-ANAG-005; Phase 3).

D00002980 TYLNJ 03241021-1608 11/3/1998 Bioavailability of Acetaminophen from Three Formulations ofAcetaminophen PowderPak, 1000 mg, Relative to Two Extra Strength TYLENOL® Gelcaps, 500 mg

D00002981 A Phase IV Comparative Study of the Effects of Acetaminophen 1000 mg, Ketoprofen 25 mg, and Placebo on Gastric and Duodenal Mucosa in Man.

D00002982 TYLNJ 00625059-5062 Tramadol With Acetaminophen in the Pain of Osteoarthritis of the Hip or Knee,

D00002983 TYLNJ 03563106-3734 11/2/1997 A phase IV comparative study evaluating the onset and total analgesia using a single dose of acetaminophen 1000 mg, ketoprofen 25 mg, ketoprofen 12.5 mg, or placebo in post-operative dental pain. CSR 223.

D00002984 TYLNJ 06009548-9623 3/10/1997 A phase IV parallel, double-blind, randomized, single-dose study comparing the analgesic efficacy and safety of acetaminophen 1000 mg/day, naproxen sodium 440 mg/day, and placebo in the treatment of tension headache. CSR 217.

D00002985 TYLNJ 04149927-9997 10/13/1997 A phase II comparative study using a single dose of acetaminophen, acetaminophen/cyproheptadine, cyproheptadine alone, and placebo in the treatment of episodic tension-type headache. CSR 230.

D00002986 TYLNJ 04013305-3347TYLNJ 03823600-3634

1/11/1996 A Phase IV Double-Blind, Crossover, Randomized Study Comparing the Effects of Naproxen Sodium 660 mg/day, Acetaminophen 4000 mg/day, and Placebo on Gastric and Duodenal Mucosa in Man.

D00002987 TYLNJ 03940317-0359 9/19/1994 A phase IV comparative study evaluating the onset of analgesia using a single dose of acetaminophen 1000 mg, naproxen sodium 440 mg, naproxen sodium 220 mg or placebo in post-operative dental pain. CSR 189.

D00002988 TYLNJ 03941492-1535 9/19/1994 A phase IV comparative study evaluating the onset of analgesia using a single dose of acetaminophen 1000 mg, naproxen sodium 440 mg, naproxen sodium 220 mg, or placebo in postoperative dental pain. CSR 188.


D00002989 TYLREP 00731089-1140 3/4/1994 A Double-Blind Crossover Study Comparing the Effects of Naproxen 750 mg/day, Acetartiinophen 4000 mg/day, Aspirin 2600 mg/day, and Placebo on Gastric and Duodenal Mucosa in Man.

D00002990 TYLREP 00576663-6705 1/11/1996 A Phase IV Double-Blind, Crossover, Randomized Study Comparing the Effects of Naproxen Sodium 660 mg/day, Acetaminophen 4000 mg/day, and Placebo on Gastric and Duodenal Mucosa in Man.

D00002991 A single dose study to compare the analgesic efficacy and safety of acetaminophen 1000 mg, naproxen 375 mg and placebo in the treatment of tension headache. CSR 175.

D00002992 A Double-Blind Crossover. Study Comparing the Effects of Naproxen 750 mg/day, Acetaminophen 4000 mg/day, Aspirin 2600 mg/day, and Placebo on Gastric and Duodenal Mucosa in Man.

D00002993 A Multi-Clinic Double-Blind Controlled Multiple Dose . Randomized Study Comparing the Efficacy and Safety of Naproxen 1000 mg Daily, Naproxen 500 mg Plus Acetaminophen 4 gm Daily and Naproxen 250 mg Plus Acetaminophen 4 gm Daily in the Treatment of Rheumato

D00002994 TYLNJ 04070604-0703 6/10/1993 A Comparison of the Efficacy and Side Effects Profiles of a Daily Dose of 1000 mg Naproxen, 500 mg Naproxen Plus 4 gm Acetaminophen, and 250 mg Naproxen Plus 4 gm Acetaminophen in the Symptomatic Treatment of Osteoarthritis of the Hip of Knee Over a Twelv

D00002995 TYLNJ 06180156-0190 11/30/1992 A comparative study using a single dose of acetaminophen, acetaminophenfpseudoephedrine, pseudoephedrine alone, and placebo in dental pain. CSR 163.

D00002996 TYLNJ 06180091-0128 4/24/1991 A double-blind, single dose, placebo-controlled, randomized study comparing the efficacy and safety of acetaminophen sustained release 1300 mg to regular release acetaminophen 1000 mg, naproxen 500 mg, and placebo in the treatment of post-operative dental

D00002997 TYLNJ 06180129-0155 6/28/1991 A Double-Blind Placebo Controlled Single Dose Randomized Study Comparing the Efficacy and Safety of Acetaminophen Sustained Release 1300 mg to Acetaminophen Regular Release 1000 mg, or Naproxen 500 mg in the Treatment of General Surgical Postoperative Pai


D00002998 TYLNJ 04293252-3280 3/29/1991 A Single-Blind Crossover Study Comparing the Effects of Extra- Strength Tylenol, Bayer Aspirin, Bayer Plus, Tri-Buffered Bufferin, and Placebo on Gastric and Duodenal Mucosa in Man.

D00002999 TYLREP 00160500-0512 7/19/1991 A Double-Blind Placebo-Controlled Parallel Study Comparing the Effects of Acetaminophen and Aspirin on Cerebral Blood Flow.

D00003000 TYLNJ 03982780-2791 12/4/1991 The Effects of Acetaminophen, Ibuprofen, and Placebo on Blood Pressure Control in Subjects Taking Anti-Hypertensive Medications.

D00003001 TYLNJ 01320301-0345 4/4/1991 A Double-Blind Placebo-Controlled Single Dose Randomized Study Comparing the Efficacy and Safety of Ibuprofen 400 mg/Pseudoephedrine 60 mg, Acetaminophen 1000 mg/Pseudoephedrine 60 mg, and Ibuprofen 200 mg/Pseudoephedrine 30 mg in the Treatment of Sinus H

D00003002 TYLNJ 03982797-2889 9/16/1991 EffectS of an Acetaminophen- Dextromethorphan Combination on Cough in Patients With Chronic Bronchitis.

D00003003 TYLNJ 03416322-6436 5/21/1990 A study comparing the efficacy and safety of acetaminophen sustained release 1300 mg to acetaminophen regular release 650 mg in the treatment of post-operative dental pain. CSR 124.

D00003004 TYLNJ 01199306-9362 3/5/1990 A multi-clinic double-blind controlled multiple dose randomized study comparing the efficacy and safety of acetaminophen sustained release 1300 mg to acetaminophen regular release 1000 mg in the treatment of pain secondary to osteoarthritis. CSR 121.

D00003005 BOKA 000027445-27523 5/22/1990 A Study Comparing the Efficacy and Safety of Acetaminophen Sustained Release 1300 mg to Acetaminophen Regular Release 650 mg in the Treatment of Post- Operative Episiotomy Pain.

D00003006 TYLREP 00160411-0431 6/11/1990 A Double-Blind Crossover Study Comparing the Effects of Acetaminophen 4 g Daily, Naproxen 800 mg Daily, and Placebo on Gastric and Duodenal Mucosa in Man.

D00003007 TYLNJ 06222859-2890 7/00/1990 A Six Cell Placebo Controlled Crossover Comparison of the Antitussive Activity of Liquid Combinations: Robitussin DM, Formula 44D, Tylenol cold, Acetaminophen/Dextromethorphan, Placebo by Citric Acid Aerosol Induced Cough Procedure,

D00003008 TYLNJ 03542200-2288 5/4/1989 A double-blind placebo controlled study to evaluate the efficacy and side effects of acetaminophen, ibuprofen, and placebo in treating aches and pains associated with common viral syndromes (ie, viral influenza and upper respiratory tract viral illnesses)


D00003009 A double-blind, single dose parallel study to compare analgesic efficacy and side effects profile of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, and placebo in the treatment of muscle contraction ('tension') headache. Stat Rpt 77.

D00003010 BOKA 000027251-27263 6/23/1986 A double-blind, multi-clinic single dose evaluation of the comparative analgesic efficacy of acetaminophen 650 mg, ibuprofen 200 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 67.

D00003011 TYLNJ 06330875-1393 A double-blind, single dose evaluation of the comparative efficacy of acetaminophen 1000 mg, ibuprofen 200 mg, ibuprofen 400 mg, and placebo in the • treatment of pain following periodontal surgery. Stat Rpt 66.

D00003012 TYLNJ 01199014-9055 A phase IV multicenter clinical investigation of the safety and efficacy of APAP 1000 mg (total daily dose of 4 grams), ibuprofen 400 mg (total daily dose of 1200 mg), and placebo in the, management of the symptoms of primary dysmenorrhea. Stat Rpt 73.

D00003013 A phase IV collaborative multi-clinic, double-blind study to compare efficacy and side effects profile of acetaminophen and ibuprofen in the treatment of pain secondary to osteoarthritis. Stat Rpt 72.

D00003014 TYLREP 00159758-9840 7/24/1986 A Double-Blind Study of the Comparative Effects of Ibuprofen 1200 mg/day, Acetaminophen 3000 mg/day and Placebo on Blood Pressure Control in Patients With Treated Hypertension.

D00003015 TYLNJ A double-blind, single dose • evaluation of the comparative analgesic efficacy of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, andplacebo in the treatment of pain •following oral surgery. Stat Rpt 58.

D00003016 A pilot evaluation of the analgesic efficacy and adverse effect liability of acetaminophen 1000 mg and placebo in the treatment of pain following oral surgery. Stat Rpt 61.

D00003017 TYLNJ 06180054-0077 5/1/1985 A double-blind single dose evaluation of the efficacy andsafety of ibuprofen 400 mg, .ibuprofen 200 mg, APAP 1000 mg, and placebo in the treatment of pain following removal of impacted third molars. Stat Rpt 60.

D00003018 Double-Blind Single Dose Study to Compare APAP 1000 mg and Placebo in Dental Pain Model Involving Root Canal

D00003019 Double-Blind, Single Dose Study to Compare APAP 1000 mg and Placebo in a Dental Pain Model Involving Periodontal Surgery. •


D00003020 TYLREP 00159651-9659 1/9/1985 A Double-Blind, Crossover Study on the Comparative Effects of Acetaminophen (4 g/day), Ibuprofen (1200 mg/day) and Placebo on Gastric and Duodenal Mucosa in Man.

D00003021 TYLNJ 03543991-4066 1/23/1985 An Interim Analysis of the Double-Blind, Single-Dose Evaluation of the Comparative Analgesic Efficacy of Acetaminophen 650 mg, Acetaminophen 1000 mg, and Placebo in the Treatment of Pain Following Oral Surgery.

D00003022 A Double-Blind, Single Dose Evaluation of the Comparative Analgesic Efficacy of Acetaminophen 1000 mg, and Placebo in the Treatment of Postoperative Pain Following Oral Surgery

D00003023 BOKA 000027238-27249 9/5/1984 A double-blind single dose evaluation.of the efficacy and safety of acetaminophen 650 mg, ibuprofen 200 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 51.

D00003024 TYLNJ 0119047-9080 A double-blind, single dose evaluation of the relative analgesia and safety of acetaminophen 2000 mg, 1500 mg, 1000 mg, 500 mg, pain following oral or periodontal surgery. Stat Rpt 49.

D00003025 A double-blind single dose evaluation of the efficacy and safety of acetaminophen 1000 mg, ibuprofen 200 mg, ibuprofen 400 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 52.

D00003026 BOKA 000027265-27276 12/3/1984 A double-blind single dose study of the efficacy and safety of acetaminophen 650 mg, ibuprofen 200 mg, and placebo in the treatment of pain following an episiotomy. Stat Rpt 54.

D00003027 Summary of the StatisticalAnal yses for Protocol No. 4-413

D00003028 A Blind, Crossover Study to Compare the Effects of Acetaminophen 4 g/day, Ibuprofen 1200 mg/day, and Placebo on the Gastric and Duodenal Mucosa in Man.

D00003029 A phase IV double-blind single dose study of the efficacy and safety of acetaminophen 1000 mg, aspirin 1000 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 45.

D00003030 TYLNJ 01190083-0106 11/4/1983 A phase IV double-blind single dose study of the safety and efficacy of acetaminophen 1000 mg, Gemnisyn 1300 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 46. .

D00003031 TYLNJ 01190109-0125 11/29/1983 A phase IV double-blind single dose evaluation of the safety and efficacy of acetaminophen 1000 mg, aspirin 650 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 47.


D00003032 TYLNJ 03460443-0566 A Cooperative Double-Blind Study of Tolmetin Sodium, Acetaminophen and Tolmetin Sodium/Acetaminophen in Combination in the Treatment of Rheumatoid Arthritis

D00003033 A Phase IV Double-Blind Single Dose Study of the Safety and Efficacy of Acetaminophen 1000 mg, Aspirin 650 mg, and Placebo in the Treatment of Pain Following Oral Surgery.

D00003034 TYLNJ 06180043-0052 1/14/1983 Summary of the Interim Statistical Analysis of the Phase IV Double-Blind Study Comparing the Analgesic Efficacy of Acetaminophen 1000 mg, Ibuprofen 100 mg, 200 mg, 400 mg, and Placebo in Pain Following Oral Surgery.

D00003035 A phase IV double-blind single dose study of the relative analgesicpotency of acetaminophen, •acetaminophen with caffeine, caffeine, and placebo in postoperative oral surgery pain.

D00003036 TYLNJ 01190128-0148 3/22/1982 A double-blind, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery. Stat Rpt 26.

D00003037 TYLNJ 01099396-9434TYLNJ 01199435-9456

A phase IV double-blind 13 week study to compare the efficacy and safety of acetaminophen and arthritis strength Bufferin in the treatment of osteoarthritis. Stat Rpt 34.

D00003038 A Double-Blind, Multi-Clinic Study Comparing PARAFON FORTE Tablets, PARAFLEX Chlorzoxazone, Acetaminophen and Placebo in Patients With Acute Musculoskeletal Symptoms

D00003039 TYLNJ 03460593-0633 7/16/1982 A Double-Blind Study of PARAFON FORTE, Acetaminophen, PARAFLEX, and Placebo in Outpatients Following Surgical. Removal of Impacted Third Molars

D00003040 Reanalysis of Data From a Multi- Center Three Cell Study of PARAFON FORTE versus PARAFLEX versus Acetaminophen.

D00003041 A Collaborative Double-Blind Study of Zomepirac Sodium Versus Acetaminophen Versus Aspirin in the Treatment of Patients With Rheumatoid Arthritis or Osteoarthritis Maintained on Nonsteroidal Anti-inflammatory Drugs Who Have Pain Requiring Supplemental Ana


D00003042 TYLNJ 03543047-3095 9/2/1982 A Comparison of the Antitussive Activity of 1000 mg APAP/30 mg Dextromethorphan Liquid, 30 mg Dextromethorphan Liquid, Placebo Liquid, and 1000 mg APAP Liquid in Volunteers With Cough Induced by a 5% Citric Acid Aerosol Stimulus.

D00003043 BOKA 000027431-27444 11/10/1982 A Phase IV Double-Blind Single Dose Study of the Relative Efficacy and Safety of Acetaminophen 650 mg, Acetaminophen 650 mg With Phenyltoloxamine Citrate 60 mg, Phenyltoloxamine Citrate 60 mg, and Placebo in the Treatment of Postoperative Pain Following 0

D00003044 Summary of the Statistical Analysis Analgesic Activity of 650 mg, 1000 mg, Acetaminophen and Placebo in an Experimental Pain Model of the Study Comparing theAPAP

D00003045 A Double-Blind, Multi-Clinic Study Comparing PARAFON FORTE Tablets, PARAFLEX Chlorzoxazone, Acetaminophen, and Placebo in Patients With Acute Musculoskeletal Symptoms.

D00003046 TYLNJ 03459026-9027 6/2/1982 Summary of Statistical Analyses for the Study of the Comparative Effects of Alcohol, Aspirin, and Acetaminophen on Gastric and Duodenal Mucosa in Man

D00003047 A Multi-Clinic Report on the Relative Effectiveness of PARAFON FORTE tablets, PARAFLEX Chlorzoxazone tablets, and Placebo as Prescribed for the Relief of Pain Associated With Skeletal Muscle Spasms of the Lower Back Excluding Investigators Scheiner (#10)

D00003048 An Evaluation of the Efficacy and Safety of C-54 Cold Liquid in Patients with Symptomatology of tipper Respiratory Infection or Allergic Rhinitis Accompanied by a Cough. Statistical Report #37.

D00003049 A phase IV double-blind study of the relative analgesic potency of acetaminophen, aspirin and placebo tablets. Stat Rpt 20 R1.

D00003050 TYLNJ 01190188-0206 7/23/1981 A double-dose, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg,acetaminophen 1000 mg and ,placebo in the treatment of postoperative pain following oral surgery. Stat Rpt 19.

D00003051 Summary of the Statistical Analysis of the Double-Blind Study Comparing the Relative Analgesic Effectiveness of 1000 mg of Acetaminophen, 650 mg of Aspirin and Placebo in Episiotomy Pain.


D00003052 TYLNJ 01190161-0185 9/14/1981 A Phase IV Double-Blind Study of the Relative Analgesic Potency of Orally Administered Tylenol Acetaminophen, Aspirin and Placebo Tablets - Interim Analysis. Rpt 20.

D00003053 Analysis of the Phase IV Double- Blind Study Comparing the Analgesic Effectiveness of 1000 mg Versus 650 mg of Acetaminophen and Placebo in Episiotomy Pain

D00003054 Update of the Summary of the April 10, 1981 Interim Statistical Analysis of the Phase IV Double-Blind Study Comparing the Analgesic Effectiveness of 1000 mg Versus 650 mg of Acetaminophen. and Placebo in Episiotomy Pain.

D00003055 Statistical Analysis of the Double-Blind Study to Determine the Effect of Acetaminophen and Aspirin on the Fecal Blood Loss in Normal Elderly Volunteer Subjects.

D00003056 Summary of the Statistical Analysis of the Double-Blind Single Dose Study of Acetaminophen Versus Caffeine Versus Placebo in Postoperative Oral Surgery Pain.

D00003057 A Double-Blind, Single Dose Evaluation Comparing the Analgesic Efficacy and Adverse Effect Liability of Phenyltoloxamine (60 mg) With Acetaminophen (1000 mg), Aspirin (650 mg) and Placebo in the Treatment of Postoperative Pain Following Oral Surgery.

D00003058 An Evaluation of the Efficacy and Safety of C-6 Cough/Cold Tablets in Adult Patients with Symptomatology of Upper Respiratory Infection or Allergic Rhinitis. Statistical Report #18.

D00003059 An Evaluation of the Efficacy and Safety of C-30-13 Cough-Cold Formula in Adult and Pediatric Patients With Symptomatology of Upper Respiratory Infection or Allergic Rhinitis.

D00003060 A multi-clinic report on the relative effectiveness of Parafon Forte tablets, Paraflex chlorzoxazone tablets, Tylenol acetaminophen tablets, and placebo as prescribed for the relief of pain associated with skeletal muscle spasms of the back. S & SI

D00003061 TYLREP 00158871-8876 1/7/1980 Summary of the Statistical Analyses of the Phase IV Multicenter Comparison of the Analgesic Effectiveness of Tylenol Acetaminophen, Acetaminophen with Caffeine (C-31), Aspirin and Placebo in Episiotomy Pain.


D00003062 A Multi-Clinic Report on the Relative Effectiveness of PARAFON FORTE Tablets, PARAFLEX Chlorzoxazone Tablets, and TYLENOL Acetaminophen Tablets as Prescribed for the Relief of Pain Associated With Skeletal Muscle Spasms of the Lower Back

D00003063 A Multi-Clinic Report on the Relative Effectiveness of PARAFON FORTE Tablets, PARAFLEX Chlorzoxazone Tablets, TYLENOL Acetaminophen Tablets and Placebo.

D00003064 Factorial Analysis of a Multi-Clinic Study on the Relative Effectiveness of PARAFON FORTE Tablets, PARAFLEX

Chlorzoxazone, Tylenol Acetaminophen, and Placebo.

D00003065 The Safety of Acetaminophen in Patients With Liver Disease

D00003066 A Phase IV Double-Blind Study to Determine the Effect of Acetaminophen, Aspirin, and Bufferin on Fecal Blood Loss in Normal Volunteer Subjects.

D00003067 A Multi-Clinic Report on the Relative Effectiveness of PARAFON FORTE Tablets, PARAFLEX Chlorzoxazone Tablets, and Placebo as Prescribed for the Relief of Pain Associated With Skeletal Muscle Spasms of the Lower Back.

D00003068 Phase IV Safety and Efficacy Study of C-30 Liquid Cough-Cold Formula

D00003069 A Combined Analysis of the Data Provided by Drs. J. Hopkinson and R. Posatko for the Comparative Efficacy of Tylenol Extra-Strength, Tylenol Regular Strength and Placebo in Episiotomy Pain.

D00003070 Efficacy and safety study of Tymed acetaminophen adult liquid pain reliever in adults with pain and/or fever. Stat Rpt 3.

D00003071 A Phase IV Double-Blind Study of TYMED Acetaminophen Elixir, Buffered Aspirin Tablets, TYLENOL Tablets and Placebos inEpisiotomy Pain

D00003072 Interim Statistical Analysis of the Study Conducted With Tylenol Acetaminophen Versus Aspirin Versus Placebo in the Treatment of Osteoarthritis of the Knees.

D00003073 Summary of the Interim Statistical Analyses of the Phase III Study of Tylenol Acetaminophen vs. Aspirin vs. Placebo in the Treatment of Rheumatoid Arthritis.

D00003074 A Combined Analysis of the Data Provided by Drs. J. Hopkinson, W. Bare, and R. Posatko's Tylenol 500 (Acetaminophen) Studies


D00003075 Dr. John Hopkinson's Tylenol 500 (Acetaminophen) Study

D00003076

TYLNJ 04452961-3257

5/25/2007Response to Docket No. 1977N-0094L, FDA-Proposed Rule IAAA, McNeil Consumer Healthcare, Volume 3

D00003077 Bringing an Over-the-Counter (OTC) Drug to Market

D00003078 TYLNJ 08504502 Tylenol Extra Strength Print Ad

D00003079 10/00/2014 FDA Draft Guidance, Over-The-Counter Pediatric Liquid Drug Products Containing Acetaminophen

D00003080 TYLNJ 02567738 Adult Cases of Moderate-Severe or Fatal Hepatic Events at a Reported Therapeutic Dose of Acetaminophen used for a Therapeutic Indication (slide)


D00003082 11/00/2000 PhRMA/FDA/AASLD Drug-Induced Hepatotoxicity White Paper Postmarketing Considerations

http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/ucm091462.pdf

D00003083 TYLNJ 01572754-806 12/12/2005 Tylenol OA and Platinum Data

D00003084 TYLNJ 01528083-108 Platinum Executive Summary

D00003085 TYLNJ 03384946 1/31/1985 Mucomyst Approval Letter

D00003086 Acetadote Approval Letter

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-539_Acetadote_Approv.pdf

D00003087 TYLNJ 08777059 Summary Chart - McNeil Funded Investigator Initiated Studies on APAP

D00003088 FDA, Federal Food Drug and Cosmetic Act (FDCA)

D00003089 FTC, Advertising FAQ's: A Guide for Small Business

D00003090 WebMD, Safe Use of OTC Pain Relievers

D00003091 TYLREP01829653-901 Annual Report NDA 19-872 No. 1

D00003092 TYLREP01829902-67 Annual Report NDA 19-872 No. 1 Addendum








D00003100 TYLREP 01832061-907 Annual Report NDA 19-872 No. 9

D00003101 TYLNJ 06021709-17 Annual Report NDA 19-872 No. 9 Addendum


D00003103 TYLNJ 06021718-3160 Annual Report NDA 19-872 No. 11 - Part 1




D00003107 TYLREP01845829-6089 Annual Report NDA 19-872 No. 11 Addendum


D00003108 TYLNJ 06014696-7069 Annual Report NDA 19-872 No. 12







D00003115 American Liver Foundation Annual Report 2004









D00003124 Medline Plus listing of products containing acetaminophen

http://www.nlm.nih.gov/medlineplus/druginfo/meds/a681004.html#brand-name-1]

D00003125 RUCAM Scoring System

http://livertox.nih.gov/rucam.html

D00003126 1/22/2004 Letter from FDA to State Boards of Pharmacy regarding Acetaminophen Hepatotoxicity and Nonsteroidal Anti-Inflammatory Drug (NSAID)-related Gastrointestinal and Renal Toxicity

D00003127 U.S. Food and Drug Administration, About FDA, What We Do (http://www.fda.gov/aboutfda/whatwedo/default.htm)

D00003128 U.S. Food and Drug Administration, Report on Global Engagement, April 23, 2012 (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM298578.pdf).

D00003129 Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/)

D00003130 FDA Regulatory Overview GRASE http://www.accessdata.fda.gov/scripts/cder/training/OTC/topic3/topic3/da_01_03_0040.htm (Accessed March 24, 2015).

D00003131 U.S. Food and Drug Administration, Over-the-Counter Drug Monograph System, Past, Present and Future, Public Hearing, March 25, 2014, Transcript. (((http://www.fda.gov/downloads/drugs/newsevents/ucm395178.pdf at page 67.


D00003132 5/11/1972 37 Fed Reg 9464-9475

D00003133 10/23/1998 63 Fed Reg 56802-819

D00003134 21 CFR 312

D00003135 21 CFR 200

D00003136 21 CFR 201

D00003137 21 CFR 10.30

D00003138 21 USC 301 Food Drug and Cosmetics Act

D00003139 11/16/2010 FDA Safe Use Initiative Public Workshop Transcript

D00003140 07/00/2011 FDA Consumer Health Information

D00003141 00/00/2013 FDA Safe Use Initiative 2013

D00003142 4/20/1972 37 Fed Reg 7820-7824

D00003143 U.S. Census Bureau, Population Division. Table 1. Annual Estimates of the Population for the United States, Regions, States, and Puerto Rico: April 1, 2010 to July 1, 2014 (NST-EST2014-01). Release Date: December 2014. https://www.census.gov/popest/data/national/totals/2014/index.html

D00003144 FDA Acetaminophen Information. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm Page Last Updated: 01/09/2015

D00003145 Tylenol Dosage for Adults. http://www.tylenol.com/safety-dosing/usage/dosage-for-adults

D00003146 McBurney RN. AASLD-FDA-NIH-PhRMA Hepatotoxicity Steering Group Meeting, 2006 Presentations: The Liver Toxicity Biomarkers Study CRADA [Cooperative Research and Development Agreement]. http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/ucm079281.htm

D00003147 TYLREP00733668-71 6/16/1994 Letter from Vivian Chester to Pilot Drug Evaluation Staff Director re NDA 17-552 Special Supplement

D00003148 TYLNJ 04097137 6/24/1994 Record of Contact regarding Acetaminophen Labeling

D00003149 TYLNJ 04274784 6/24/1994 Record of Contact regarding Acetaminophen Labeling

D00003150 74 Fed Reg 61513-516

D00003151 TYLNJ 03276968-7216 Briefing Materials for June 29-30, 2009 AdCom Meeting

D00003152 TYLNJ 04757654-74 Peter Luther Presentation re Reducing Potential Acetaminophen Overdose and Liver Injury

D00003153 TYLNJ 06356793-907 Postmarketing Surveillance Ad Hoc Report on the Impact of Dose and Liver Abnormalities in Users of Paracetamol (Acetaminophen)

D00003154 TYLNJ 04273911-13 3/6/1972 Memo regarding Tylenol 500

D00003155 9/19-20/2002 Advisory Committee Meeting Transcript

D00003156 TYLNJ 02592279-2527 Presentation regarding safe use of acetaminophen


D00003157 TYLNJ 04273264 7/18/2001 Letter from Paula Oliver to FDA regardng AERs from 6/8/00 through 6/7/01

D00003158 TYLREP01829557-58 Marketing spreadsheet

D00003159 TYLNJ 04380650-946 Response to Docket No. 1977N-0094L, FDA-Proposed Rule IAAA, McNeil Consumer Healthcare, Volume 1

D00003160 00/00/2010 Johnson & Johnson 2010 Contributions Report

D00003161 TYLNJ 03830571 9/21/1995 J&J Memo re: American Liver Foundation Contribution

D00003162 TYLNJ 03830572 10/16/1995 Letter to ALF from McNeil

D00003163 TYLNJ 02545956 7/18/2006 Baggish e-mail re: ALF press release

D00003164 TYLNJ 07257359 7/27/2006 E-mail from Temple to Cullen

D00003165 TYLNJ 05918559 2/26/2007 Email re: ALF meeting

D00003166 TYLNJ 02548165 12/20/2006 Email from Baggish to Kuffner

D00003167 TYLNJ 07488819 11/3/2006 Email re: contributions

D00003168 TYLNJ 10447807-809 10/15/2009 Letter from Stephen Klincewicz to Kirk Sooter regarding response to 483 observation

D00003169 FDA Form 3500

D00003170 FDA Form 3500A

D00003171 6/19/1998 June 19, 1998 ALF Letter

D00003172 5/4/2007 Letter from Corwin to Baggish

D00003173 7/1/2015 FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugswww.fda.gov/consumer

D00003174 10/9/2009 Tylenol Extra Strength Label

D00003175 4/9/2010 Tylenol Regular Strength Label


D00003177 1/10/2011 Tylenol Regular Strength Label

D00003178 1/29/2004 Tylenol Cold Multi-Symptom Blister Pack

D00003179 4/18/2011 Tylenol Cold Multi-Sypmtom Label





D00003184 Tylenol Extra Strength Bottle

D00003185 Regular Strength Tylenol Bottle

D00003186 Tylenol Cold

D00003187 Aleve Bottle

D00003188 12/7/2005 Email re: telecon follow-up

D00003189 12/1/1972 Clinical Summary Tylenol 500 (Acetaminophen)

D00003190 12/19/1972 Tylenol Extra Strength Capsules, NDA 17-053, Vol. 1 of 5








D00003197 3/00/2010 WHO Model List of Essential Medicines (Updated), 16th list

D00003198 08/00/2011 Alevel Label

D00003199 9/22/2015 RUCAM Causailty Assessment Worksheethttp://www.livertox.nih.gov/livertoxrucamv5.pdf

D00003200 USC Intern Survival Guide

D00003201 USC Department of Surgery Website Page

D00003202 9/23/2015 WHO Constitution of WHO principles

D00003203 6/29-6/30/2009 Roster of 2009 Advisory Committee Members

D00003204 Vote Results of 2009 Advisory Committee

D00003205 9/19/-9/20/2002 FDA Background Package

D00003206 Bass Commercial

D00003207 Pawelski Commercial

D00003208 Post Operative Care - Columbia University Department of Surgery

D00003209 9/1/2013 Tygacil Label (2013)

D00003210 Various excerpts from fda.gov


ID/Offered

Date Admitted Date

EXHIBIT DESCRIPTIONDLT000001 AAD Lip augumentation offers something to smile about. August 2012DLT000002 AASLD Meeting Poster Hepatology 52(4) (121A-319A)DLT000003 Abboud, G., & Kaplowitz, N. (2007). Drug-induced liver injury. Drug Safety,30(4), 277-294.DLT000004 Abdualmjid RJ, et al: Hepatotoxic botanicals - an evidence-based systematic review. J Pharm Pharmaceut Sci

2013;16:376-404.DLT000005 Acetaminophen and Liver Injury: Q&A for Consumers;

http://www.fda.gov/downloads/forconsumers/consumerupdates/ucm172664.pdfDLT000006 Acetaminophen overdose and liver damage. Journal of the American Dental Association. 2010; 141(9). 1158.

http://jada.ada.org/content/141/9/1158.full.pdf+html?sid=160d1a10-2e9b-4357-813c-d1d61f56be2aDLT000007 Acetaminophen Overdose and Liver Injury - Background and Options for Reducing Injury (2009)

http://www.fda.gov/downloads/AdvisoryCommittees/.../UCM164897.pdfDLT000008 Acetaminophen Safety. Ped. Parents, Jan. 1, 2011. http://www.readperiodicals.com/201101/2336187251.html.

accessed April 2, 2013.DLT000009 Acetaminophen When Taken as Directed, is Safe for Patients with Liver Disease.

http://www.hepassoc.org/news/article110.html, accessed March 26, 2013.DLT000010 Acharya (2002) Etiopathogenesis of acute hepatic failure - Eastern vs Western countries [S268-S273]DLT000011 ACR Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the

Hand, Hip, and Knee. April 2012 DLT000012 Acute Liver Failure Study Group: Overview. (2014). Retrieved from xttp://www.utsouthwestern.edu/labs/acute-

liver/overview/DLT000013 Acute liver failure. (2014). US National Library of Medicine. http://livertox.nlm.nih.gov/Phenotypes_fail.htmlDLT000014 Adams. Guidelines for the Early Management of Adults with Ischemic Stroke. American Heart Association Journals .

2007; 38. 1655-1711DLT000015 AFP Information from Your Family Doctor - Dyspepsia: What It Is and What to Do About It. December 2010DLT000016 AFP Information from Your Family Doctor - Knee Osteoarthritis. June 2011DLT000017 AFP Information from Your Family Doctor - What You Should Know About Osteoarthritis. January 2012DLT000018 Agarwal, Rakhee, et al. Acetaminophen-Induced Hepatotoxicity in Mice Occurs with Inhibition of Activity and

Nitration of Mitochondrial Manganese Superoxide Dismutase. The Journal of Pharmacology and Experimental

Therapeutics. 337:110-116 (2011)DLT000019 Agbabiaka, T. B., Savović, J., & Ernst, E. (2008). Methods for causality assessment of adverse drug reactions. Drug

safety, 31(1), 21-37.DLT000020 Agency for Healthcare Research and Quality. Managing Osteoarthritis: Helping the Elderly Maintain Function and

Mobility. Rockville, MD: AHRQ, May 2002; AHRQ Publication No. 02-0023.; available at: www.ahrq.goviresearch/osteoria/osteoria.htm

DLT000021 Ahmad, S. R. (2003). Adverse drug event monitoring at the Food and Drug Administration. Journal of General Internal Medicine, 18(1), 57-60.

DLT000022 Ahmad, S. R. (2007). Safety of recommended doses of paracetamol. The Lancet, 369(9560), 462-463.DLT000023 Ahmed, et al. Aldo-keto reductase-7A protects liver cells and tissues from acetaminophen-induced oxidative stress

and hepatotoxicity. Hepatology 1-61 (2011)DLT000024 AHRQ Clinician's Guide: Choosing Non-Opioid Analgesics for Osteoarthritis. 2009DLT000025 AHRQ Guideline for Rheumatoid arthritis. The management of rheumatoid arthritis in adults. 2009DLT000026 Ajmera, V., Xia, G., Vaughan, G., Forbi, J. C., Ganova‐Raeva, L. M., Khudyakov, Y., ... & Lee, W. M. (2011). What

factors determine the severity of hepatitis A‐related acute liver failure?. Journal of viral hepatitis, 18(7), e167-e174.

DLT000027 Al Midani (2011) Saudi J Kidney Dis Transplant-Fulminant hepatitis following primary herpes simplex virus infection [107-111]

TYLENOL MASTER LITERATURE EXHIBIT LIST


DLT000028 Alander, S., et al. Pediatric Acetaminophen Overdose: Risk Factors Associated with Hepatocellular Injury. Arch

Pediatr Adolesc Med 2000; 154: 3460350.DLT000029 Alaniz C, et al: A retrospective study of the etiologies and outcomes of patients admitted to a university hospital with

presumed acetaminophen toxicity. Hosp Pharm 2007;42:126-132.DLT000030 Alatalo, Paivikki, et al. Effect of moderate alcohol consumption on liver enzymes increases with increasing body

mass index. The American Journcal of Clinical Nutrition. 88:1097-103 (2008)DLT000031 Albano, et al. Role of Cytochrome P4502E1-Dependent Formation of Hydroxyethyl Free Radical in the Development

of Liver Damage in Rats Intragastrically Fed With Ethanol. Hepatology 23:155-163 (1996)DLT000032 Albrecht, Jan. Glutamine: A Trojan Horse in Ammonia Neurotoxicity. Hepatology 44(4):788-794 (Oct. 2006).

DLT000033 Algren, D. Adam. Review of N-Acetylcysteine for the Treatment of Acetaminophen (Paracetamol) Toxicity in Pediatrics. Second Meeting of the Subcommittee of the Expert Committee on the Selection and Use of Essential

Medicines. (2008)DLT000034 Alhelail, M. A., Hoppe, J. A., Rhyee, S. H., & Heard, K. J. (2011). Clinical course of repeated supratherapeutic

ingestion of acetaminophen. Clinical Toxicology, 49(2), 108-112.DLT000035 Allard, Johane P., et al. Nutritional assessment and hepatic fatty acide composition in non-alcoholic fatty liver

disease (NAFLD): A cross-sectional study. Journal of Hepatology. 48:300-307 (2008)DLT000036 Allison, D.G. Microbial Contamination and Spoilage, in Microbiology and Sterility Assurance in Pharmaceuticals and

Medical Devices. Business Horizons 2010: 53-72DLT000037 Alomar, Mohammed, et al. Accuracy of acetaminophen dosing in children by caregivers in Saudi Arabia. Ann. Saudi

Med. 31(5):513-517 (2011)DLT000038 Alonso, E.M., et al. Fulminant hepatitis associated with centrilobular hepatic necrosis in young children. J Pediatr

1995; 127(6):888-894.DLT000039 Altman, R. D., Zinsenheim, J. R., Temple, A. R., & Schweinle, J. E. (2007). Three-month efficacy and safety of

acetaminophen extended-release for osteoarthritis pain of the hip or knee: a randomized, double-blind, placebo-controlled study. Osteoarthritis and Cartilage, 15(4), 454-461.

DLT000040 Altomare E, Leo MA, Sato C, et al: Interaction of ethanol with acetaminophen metabolism in the baboon. Biochem Pharmacol 1984;33:2207-2212.

DLT000041 Amadio P Jr, Cummings DM: Evaluation of acetaminophen in the management of osteoarthritis of the knee. Curr Ther Res 1983 Jul;34:59-66.

DLT000042 Amar PJ, Schiff ER. Acetaminophen safety and hepatotoxicity – where do we go from here? July 2007; 6 (4): 341-355. http://informahealthcare.com/doi/abs/10.1517/14740338.6.4.341

DLT000043 Ameer B, Divoll M, Abernethy DR, et al. Absolute and relative bioavailability of oral acetaminophen preparations. J Pharm Sci 1983 Aug;72:955-958.

DLT000044 There is no ExhibitDLT000045 American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical

management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum 2000 Sep;43:1905-1915.

DLT000046 An Active Approach to Osteoarthritis. American Academy of Physical Medicine and Rehabilitation. http://www.aapmr.org/practice/marketing/public/Documents/osteoarthritisbrochure.pdf

DLT000047 Anand. Consensus Statement for the Prevention and Management of Pain in the Newborn. 2001. Arch Pediatr

Adolesc Med . 2001; 155. 173-180DLT000048 Anantha, Krishna Chaitanya D., et al. Hepatoprotective effect of biherbal ethanolic extract against paracetamol-

induced hepatic damage in albino rats. Journal of Ayurveda and Integrative Medicine. 3(4):198-203 (2012)

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DLT001352 Han D, Dara L, Johnson H, Ybanez M, Saberi B, Win S, Than T, Yuan L, Sadda A, Liu ZX, and Kaplowitz N. Regulation of drug-induced liver injury by signal transduction pathways: critical role of mitochondria. Trends in Pharmacological Sciences, 34: 243-253, 2013.

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DLT001354 Hanawa N, Shinohara M, Saberi B, Gaarde W, Han D and Kaplowitz N. Role of JNK translocation to mitochondria leading inhibition of mitochondria bioenergetics in acetaminophen-induced liver injury. J Biol Chem. 283 (20):13565-77, 2008.

DLT001355 Holeski C and Kaplowitz N: New developments in drug hepatotoxicity. Curr. Opinion in Gastroent 10:313-318, 1994.


DLT001356 Jain S and Kaplowitz N. Clinical considerations of drug-induced hepatotoxicity. Comprehensive Toxicology, edition 2, Elsevier 9: 369-381, 2010.

DLT001357 Jones D, Lemasters J, Han D, Boelsterli U, and Kaplowitz N. Mechanisms of pathogenesis in drug hepatotoxicity: putting the stress on mitochondria. Molec. Interventions 10: 98-111, 2010.

DLT001358 Kaplowitz N, Aw TY, Stolz AS: Drug Hepatotoxicity. In Principles and Practices of Gastroenterology, ed. G Gitnick, Elsevier Press, 1089-1102,1988.

DLT001359 Kaplowitz N, Drug-induced liver injury: Introduction and overview. In Drug-Induced Liver Disease, third edition (Ed. Kaplowitz N. and DeLeve L.), Elsevier 3-14, 2013.

DLT001360 Kaplowitz N, Eberle D, and Yamada T: Hepatic drug metabolism and toxicity. (Chapter) in Current Hepatology Vol. I, 181-211, 1980.

DLT001361 Kaplowitz N, Eberle D, Yamada T, and Touloukian J: Hepatic drug metabolism and drug-induced liver disease. In Current Hepatology Vol 2, 195 232, 1982.

DLT001362 Kaplowitz N, Yamada T, and Ludwig S: Alcoholic and drug-induced liver diseases and bilirubin metabolism. In Current Gastroenterology and Hepatology Vol I, 310-337, 1979, Houghton Mifflin, Boston.

DLT001363 Kaplowitz N. Avoiding hepatic injury from drugs. Gastroent 117:759, 1999.DLT001364 Kaplowitz N. Drug-induced liver disorders: implications for drug development and regulation. Drug Safety 24:483-

490, 2001.DLT001365 Kaplowitz N. Drug-induced liver disorders: Introduction and overview. In Drug-Induced Liver Disease, first edition

(Ed. Kaplowitz N and DeLeve L), M. Dekker, 1-13 2002.DLT001366 Kaplowitz N. Drug-induced liver disorders: introduction and overview. In Drug-Induced Liver Disease, second edition

(Ed. Kaplowitz N. and DeLeve L.) Marcel Dekker, 1-11, 2007.DLT001367 Kaplowitz N. Hepatotoxicity of herbal remedies: insights into the intricacies of plant-animal warfare and cell death.

Gastroent. 113:1408-1412, 1997.DLT001368 Kaplowitz N. Mechanisms of cell death and relevance to drug hepatotoxicity. In Drug-Induced Liver Disease, first

edition (Ed. Kaplowitz N and DeLeve L), M. Dekker, 85-95, 2002.DLT001369 Kaplowitz N. Mechanisms of cell death and relevance to drug hepatotoxicity. In Drug-Induced Liver Disease, second

edition (Ed. Kaplowitz N. and DeLeve L.), Marcel Dekker, 85-95, 2007.DLT001370 Kaplowitz N: Avoiding idiosyncratic DILI: two is better than one. Hepatology, 58: 15-17, 2013.DLT001371 Kaplowitz N: Drug metabolism and hepatotoxicity. In Liver and Biliary Diseases (ed. N Kaplowitz), Williams &

Wilkins, 2nd Edition, pp. 103-120, 1996.DLT001372 Kaplowitz N: Drug metabolism and hepatotoxicity. In Liver and Biliary Diseases (ed. N Kaplowitz), Williams &

Wilkins, pp 82-97, 1992.DLT001373 Kaplowitz N: Drug-induced and alcoholic liver diseases. In Practical Gastroenterology, Houghton Mifflin, Boston, 195-

232, 1982.DLT001374 Kaplowitz N: Drug-induced hepatotoxicity. In Current Hepatology 7:69-102, 1987.DLT001375 Kaplowitz N: Drug-induced hepatotoxicity. In Current Hepatology, vol 6:239-268, 1986.DLT001376 Krahenbuhl S and Kaplowitz N: Drug-induced hepatotoxicity: Clinical presentation, pathogenesis, risk factors,

diagnosis and treatment. In Acute and Chronic Liver Diseases Molecular Biology and Clinics (ed. R. Schmd, L. Bianchi, H.E. Blum, W. Gerok, K.P. Maier and G.A. Stalder) Falk Symposium, Kluwer Press, pp 147-158, 1996.

DLT001377 Liu Z-X and Kaplowitz N. Immune mechanisms in drug-induced hepatotoxicity: Therapeutic implications, in Liver Immunology (ed. J Vierling, E. Gershwin) 349-360, 2007.

DLT001378 There is no ExhibitDLT001379 Liu Z-X and Kaplowitz N. Role of innate immunity in acetaminophen toxicity. Expert Opinion on Drug Metabolism &

Toxicology. 2:1-11, 2006.DLT001380 Liu Z-X, Govindarajan S and Kaplowitz N. Innate immune system plays a critical role in determining the progression

and severity of acetaminophen hepatotoxicity. Gastroenterology 127:1760-1774, 2004.DLT001381 Liu Z-X, Han D, Basuki G and Kaplowitz N. Neutrophil depletion protects against murine acetaminophen

hepatotoxicity. Hepatology, 43:1220-1230, 2006.DLT001382 Lu S and Kaplowitz N: Acetaminophen hepatotoxicity. In Gastrointestinal Emergencies (Williams & Wilkins, ed.

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influence of age and gender. Hepatology 49: 2001-2009, 2009.DLT001385 Lucena M, Kaplowitz N, Hallal H et al. Recurrent drug-induced liver injury with different in the Spanish Registry. The

dilemma of the relationship to autoimmune hepatitis. J. Hepatol. 55:820-7, 2011.DLT001386 Nathwani R and Kaplowitz N. Drug hepatotoxicity. Clinics Liver Disease, 10:207-217, 2006.DLT001387 Pham T-V, Lu S, and Kaplowitz N: Acetaminophen hepatotoxicity. In Gastrointestinal Emergencies (Williams &

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acetaminophen hepatotoxicity and attenuates JNK activation and loss of GCL and Mcl1. J. Biol. Chem. 285: 8244-8255, 2010.

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requires mitochondrial Sab expression. J. Biol. Chem, 286:35071-35078, 2011.DLT001396 Zimmerman, H. J. (2000). Hepatology: A century of progress. Clin Liver Dis, 4, 73-96.DLT001397 Kalsi, S., et al. A review of the evidence concerning hepatic glutathione depletion and susceptibility to hepatotoxicity

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DLT001644Henderson, C., et al. (2000). Increased resistance to acetaminophen hepatotoxicity in mice lacking glutathione S-transferase Pi. Proceedings of the National Academy of Sciences. 97;12741-12745.

DLT001645Hogaboam, C., et al. (1999). Novel CXCR2-dependent liver regenerative qualities of ELR-containing CSC chemokines. The FASEB Journal. 13;1565-1574.

DLT001646Hogaboam, C., et al. (1999). Macrophage inflammatory protein-2 gene therapy attenuates adenovirus- and acetaminophen-mediated hepatic injury. Gene Therapy. 6;573-584.

DLT001647Hogaboam, C., et al. (2000). Exaggerated hepatic injury due to acetaminophen challenge in mice lacking C-C- chemokine receptor 2. American Journal of Pathology. 156;1245-1252.

DLT001648Ishida, Y., et al. (2002). A pivotal involvement of IFN-y in the pathogenesis of acetaminophen-induced acute liver injury. The FASEB Journal. 16;1227-1236.

DLT001649Ishida, Y., et al. Opposite roles of neutrophils and macrophages in the pathogenesis of acetaminophen-induced acute liver injury. European Journal of Immunology. 36;1028-1038.

DLT001650Ju, C., et al. (2002). Protective role of Kupffer cells in acetaminophen-induced hepatic injury in mice. Chemical Research in Toxicology. 15;1504-1513.

DLT001651Lee, S., et al. (1996). Role of CYP2E1 in the hepatotoxicity of acetaminophen. The Journal of Biological Chemistry. 271;12063-12067.

DLT001652Limaye, P., et al. (2003). Calpain released from dying hepatocytes mediates progression of acute liver injury induced by model hepatotoxicants. Toxicology and Applied Pharmacology. 191;211-226.

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Masubuchi, Y., et al. (2003). Role of interleukin-6 in hepatic heat shock protein expression and protection against acetaminophen-induced liver disease. Biochemical and Biophysical Research Communications. 304;207-212.

DLT001654Napirei, M., et al. (2006). Deoxyribonuclease 1 aggravates acetaminophen-induced liver necrosis in male CD-1 mice. Hepatology. 43;297-305.

DLT001655Okawa, H., et al. (2006). Hepatocyte-specific deletion of the keap1 gene activates Nrf2 and confers potent resistance against acute drug toxicity. Biochemical and Biophysical Research Communications. 339;79-88.

DLT001656Reilly, T., et al. (2001). A protective role for cyclooxygenase-2 in drug-induced liver injury in mice. Chemical Research in Toxicology. 14;1620-1628.

DLT001657Simpson, K., et al. (2003). Stem cell factor attenuates liver damage in a murine model of acetaminophen-induced hepatic injury. Laboratory Investigation. 83;199-206.

DLT001658Su, G., et al. (2005). Lipopolysaccharaide-binding protein modulates acetaminophen-induced liver injury in mice. Hepatology. 41;187-195.

DLT001659Tinel, M., et al. (2004). Subliminal fas stimulation increases the hepatotoxicity of acetaminophen and bromobenzene in mice. Hepatology. 39;655-666.

DLT001660Tolson, J., et al. (2006). Increased hepatotoxicity of acetaminophen in Hsp70i knockout mice. Toxicology and Applied Pharmacology. 210;157-162.

DLT001661Trepicchio, W., et al. (2001). Protective effect of rhIL-11 in a murine model of acetaminophen-induced hepatotoxicity. Toxicologic Pathology. 29;242-249.


DLT001662Welch, K., et al. (2006). Genomic identification of potential risk factors during acetaminophen-induced liver disease in susceptible and resistant strains of mice. Chemical Research in Toxicology. 19;223-233.

DLT001663Yohe, H., et al. (2006). Involvement of troll-like receptor 4 in acetaminophen hepatotoxicity. American Journal of Physiology. 290;G1269-G1279.

DLT001664Zhang, H., et al. (2000). Reduction of liver fas expression by an antisense oligonucleotide protects mice from fulminant hepatitis. Nature Biotechnology. 18;862-867.

DLT001665Zhang, J., et al. (2002). Modulation of acetaminophen-induced hepatotoxicity by the xenobiotic receptor CAR. Science. 298;422-424.

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Agarwal, V., et al. (2010). Important elements for the diagnosis of drug-induced liver injury. Clinical

Gastroenterology and Hepatology . 8;463-470.

DLT001667Harrill, A., et al. Population-based discovery of toxicogenomics biomarkers for hepatotoxicity using a laboratory strain diversity panel. Toxicological Sciences . 110;235-243.

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Watkins, P. (2013). Biomarkers for drug-induced liver injury. In: Drug Induced Liver Disease , 3rd edition, eds.

Kaplowitz, N. and Deleve, L. 275-304.

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Tolman, K., et al. (2013). Occupational and environmental hepatotoxicity. In: Drug Induced Liver Disease , 3rd

edition, eds. Kaplowitz, N. and Deleve, L. 659-676

DLT001670Chang, A., et al. (2014). Respiratory Substrates Regulate S‑Nitrosylation of Mitochondrial Proteins through a Thiol-Dependent Pathway. Chemical Research in Toxicology. 27;794-804.

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DLT001672Garcia-Ruiz, C., et al. (2015). Acid sphingomyelinase-ceramide system in steatohepatitis: A novel target regulating multiple pathways. Journal of Hepatology. 62;219-233.

DLT001673Kullak-Ublick, G., et al. (2014). Liver safety assessment in special populations (hepatitis B, C, and oncology trials). Drug Safety. 37;S57-S62.

DLT001674Robles-Diaz, M., et al. (2014). Use of Hy’s Law and a New Composite Algorithm to Predict Acute Liver Failure in Patients With Drug-Induced Liver Injury. Gastroenterology. 147;109-118.

DLT001675Robles-Diaz, M., et al. (2015). Use of Hy’s Law, R Criteria, and nR Criteria to Predict Acute Liver Failure or Transplantation in Patients With Drug-Induced Liver Injury. (Reply). Gastroenterology. 148;452-455.

DLT001676Than, T., et al. (2014). In vitro assays of mitochondrial function/dysfunction. Clinical Pharmacology and Therapeutics. 96;665-668.

DLT001677Uetrecht, J., Kaplowitz, N. (2015). Inhibition of Immune Tolerance Unmasks Drug-Induced Allergic Hepatitis. Hepatology. 62;346-348.

DLT001678Watkins, P., et al. (2015). Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database. Drug Safety. 1-11.

DLT001679Win, S., et al. (2014). JNK interaction with Sab mediates ER stress induced inhibition of mitochondrial respiration and cell death. Cell Death and Disease. 5;e989-e999.

DLT001680Win, S., et al. (2015). Sab (Sh3bp5) dependence of JNK mediated inhibition of mitochondrial respiration in palmitic acid induced hepatocyte lipotoxicity. Journal of Hepatology. 62;1367-1374.

DLT001681Harrison, A., et al. (1979). Pruritus, Cimetidine, and Polycythemia. The New England Journal of Medicine. (Reply). 300;433-434.

DLT001682Kaplowitz, N., et al. (2003). Did this drug cause my patient's hepatitis? Annals of Internal Medicine. (Reply). 138;159-60.

DLT001683Francis, G., and Kaplowitz, N. (2004). Liver injury associated with the B-interferons for MS. Neurology. (Reply). 63;1138-1143.

DLT001684Neff, G., et al. (2004). Severe hepatotoxicity associated with the use of weight loss diet supplements containing ma huang or usnic acid. Journal of Hepatology. (Reply). 41;1061-1067.

DLT001685 Kaplowitz, N. (2004). Statin-induced hepatotoxicity. (Reply). 127;1278-1279.DLT001686 Kaplowitz, N. (1980). Bile acid tolerance tests: Rationale. (Reply). 78;1654-1655.

DLT001687Robles-Diaz, M. (2014). Improved Prediction of the Need for Liver Transplantation in Patients With Drug-Induced Liver Injury. Gastroenterology. 147;1441-1442.


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Ann. Emerg. Med. 20:1058-1063.

DLT001689Atluri, et al. (2011). Pathogenesis, Diagnosis, and Treatment of Hepatic Encephalopathy. J Clin Exp Hepatol 1:77-86.

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721.DLT001692 IMS Institute for Healthcare Informatics. (2012). The use of medicines in the United States: Review of 2011.

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DLT001697Lynch, III, J.P., et al. (2010) Streptococcus pneumoniae : epidemiology and risk factors, evolution of antimicrobial

resistance, and impact of vaccines. Current Opinion in Pulmonary Medicine. 16:217-225.

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(4) 34.

DLT001699Davis, M., et al. (1976). Metabolism of Paracetamol after Therapeutic and Hepatotoxic Doses in Man. J. Int. Med.

Res. 4, Supplement (4) 40

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Levitt, David G., et al. (2016). Human serum albumin homeostasis: a new look at the roles of synthesis, catabolism, renal and gastrointestinal excretion, and the clinical value of serum albumin measurements. International Journal of

General Medicine, 2016:9; 229-255.

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Munford, R. S. (2016). Severe sepsis and septic shock. Eds. Kasper, D., Fauci, A., Hauser, S., Longo, D., Jameson,

J. L., and Loscalzo J. Harrison's Principles of Internal Medicine, 19th Edition .

DLT001702 Zakim and Boyer's Hepatology: A Textbook of Liver Disease, 6th Edition (2011).DLT001703 Goodman and Gilman's The Pharmacological Basis of Therapeutics, 12th Edition (2011).

DLT001704Rinella, Mary E., et al. (2001). Body Mass Index as a Predictor of Hepatic Steatosis in Living Liver Donors. Liver

Transpl. 2001:7-409-414.

DLT001705Green, R, Flamm, S. (2002). AGA Technical Review on the Evaluation of Liver Chemistry Tests, Gastroenterology ;

123:1367-1384.DLT001706 Flamm, S. (2015). Consultations in Liver Disease, Clin Liver Dis, xiii-xiv

DLT001707Kim, WR, et al. (2008). Serum Activity of Alanine Aminotransferase (ALT) as an Indicator of Health and Disease. Hepatology Vol. 47, No. 4; 1363-1370.

DLT001708 Flamm, S. (2012). Consultations in Liver Disease, Clin Liver Dis, xiii-xivDLT001709 Tintinalli, J., et al. (2016) Tintinalli's Emergency Medicine, A Comprehensive Study Guide, 8th Edition

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Bhattarai, J., et al. (2011) Low Serum Albumin to Differentiate Septic Shock From Other Types of Shock. Chest

Journal ; pg. 140.

DLT001711 Jones, A., et al. Chapter 6: Sepsis and Shock with Infection. Yealy's Emergency Department Critical Care. (2013).

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Jones, A., and Puskarich, M. (2011) Sepsis-Induced Tissue Hypoperfusion. Critical Care Nursing Clinics of North

America .pg. 115-125.

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Jones, A., and Puskarich, M. (2009) Sepsis-Induced Tissue Hypoperfusion. Critical Care Nursing Clinics of North

America .pg. 769-779.

DLT001714Heffner, A., et al. (2010) Etiology of Illness in Patients with Severe Sepsis Admitted to the Hospital from the Emergency Department. Clinical Infectious Disease ; 50:814-820.


DLT001715

Studnek, JR, et al. (2012) The impact of emergency medical services on the ED care of severe sepsis. The

American Journal of Emergency Medicine; 30: 51-56.

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Arnold, RC, et al. (2013) Multicenter Observational Study of the Development of Progressive Organ Dysfunction and Therapeutic Interventions in Normotensive Sepsis Patients in the Emergency Department. Academic Emergency

Medicine; pgs. 433-440.

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Guirgis, FW, et al. (2014) Persistent organ dysfunction after severe sepsis: A systematic review. Journal of Critical

Care ; pgs. 320-326.

DLT001718Jones, A. and Puskarich, M. (2014) The Surviving Sepsis Campaign Guidelines 2012: Update for Emergency Physicians. Ann Emerg Med; 63:35-47.

DLT001719 Jones, A. (2014) Unbundling Early Sepsis Resuscitation. Ann Emerg Med. ; 63:654-655.

DLT001720Sterling, A., Puskarich, M., and Jones, A. (2013) Prehospital treatment of sepsis: what really makes the "golden hour" golden? Critical Care ; 18:697.

DLT001721

O'Malley, GF, Mizrahi, F., Giraldo, P., O'Malley, RN, Rollins, D, Wilkins, D. (2015) Protein-Derived Acetaminophen-Cysteine Can Be Detected After Repeated Supratherapeutic Ingestion of Acetaminophen in the Absence of Hepatotoxicity. J. Med. Toxicol. ; 11:317-320.

DLT001722

Frey, S. M., Wiegand, T. J., Green, J. L., Heard, K. J., Wilkins, D. G., Gorodetsky, R. M., & Dart, R. C. (2015). Confirming the causative role of acetaminophen in indeterminate acute liver failure using acetaminophen-cysteine adducts. Journal of Medical Toxicology, 11(2), 218-222.

DLT001723

Ginat, D. T. (2015). Acetominophen (Tylenol, Paracetamol). In Neuroimaging Pharmacopoeia (pp. 341-345).

Springer International Publishing.

DLT001724Heard, K., Green, J. L., Anderson, V., Bucher-Bartelson, B., & Dart, R. C. (2016). Paracetamol (acetaminophen) protein adduct concentrations during therapeutic dosing. British Journal of Clinical Pharmacology, 81(3), 562-568.

DLT001725

Lee, P. J., Shen, M., Wang, S., Spiegler, P., Caraccio, T., DeMuro, J. P., & Malone, B. (2015). Possible hepatotoxicity associated with intravenous acetaminophen in a 36-year-old female patient. Pharmacy and Therapeutics, 40(2), 123-132.

DLT001726Lee, W.M. Acetaminophen and the Liver: Poison or Panacea? Internal Medicine Grand Rounds, UTSW, May 20, 2016.

DLT001727Rule, J. A., Hynan, L. S., Attar, N., Sanders, C., Korzun, W. J., Lee, W. M., & Acute Liver Failure Study Group. (2015). Procalcitonin identifies cell injury, not bacterial infection, in acute liver failure. PloS One, 10(9), 1-13.

DLT001728Schiodt, F. V., Ott, P., Christensen, E., & Bondesen, S. (2002). The value of plasma acetaminophen half-life in antidote-treated acetaminophen overdosage. Clinical Pharmacology and Therapeutics, 71(4), 221-5.

DLT001729Seifert, S. A., Kovnat, D., Anderson, V. E., Green, J. L., Dart, R. C., & Heard, K. J. (2016). Acute hepatotoxicity associated with therapeutic doses of intravenous acetaminophen. Clinical Toxicology, 54(3), 282-285.

DLT001730

Shiffman, S., Rohay, J. M., Battista, D., Kelly, J. P., Malone, M. K., Weinstein, R. B., & Kaufman, D. W. (2015). Patterns of acetaminophen medication use associated with exceeding the recommended maximum daily dose. Pharmacoepidemiology and Drug Safety, 24(9), 915-921.

DLT001731Arnold, S. M., Els, T., Spreer, J., & Schumacher, M. (2001). Acute hepatic encephalopathy with diffuse cortical lesions. Neuroradiology, 43(7), 551-554.

DLT001732Fridman, V., Galetta, S. L., Pruitt, A. A., & Levine, J. M. (2009). MRI findings associated with acute liver failure. Neurology, 72(24), 2130-2131.

DLT001733Ginat, D. T., Small, J., & Schaefer, P. W (eds). (2015) Neuroimaging Pharmacopoeia. Springer International Publishing.


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J00000207 Rex Sherer, MD - Deposition Ex. 1

J00000208 CONFIDENTIAL HAYESD_CVSG_MDR00018-61 Rex Sherer, MD - Deposition Ex. 2




J00000211 CONFIDENTIAL HAYESD_SOSA_SSA00001-296 Rex Sherer, MD - Deposition Ex. 5

3/12/2014 Deposition of Robert Christiansen

J00000400 NJTYL_Christiansen_(Motrin) Robert Christiansen - Deposition Ex. 1

J00000401 NJTYL_Christiansen_(Motrin) Robert Christiansen - Deposition Ex. 2

J00000402 TYLNJ 01266328 Robert Christiansen - Deposition Ex. 3

J00000403 TYLNJ 01266329 - 01266370 Robert Christiansen - Deposition Ex. 4









J00000412 Robert Christiansen - Deposition Ex. 13

J00000413 TYLNJ 05380557, 05380661, 05380597 Robert Christiansen - Deposition Ex. 14



J00000416 TYLNJHC00000442 - 00000443 Robert Christiansen - Deposition Ex. 17



J00000419 NJTYL_Christiansen_COMPENSATION Robert Christiansen - Deposition Ex. 20

5/21/2014 Deposition of Kathleen G. Fallon

J00000420 NJTYL_FALLON_CV Kathleen G. Fallon - Deposition Ex. 1A

J00000421 Kathleen G. Fallon - Deposition Ex. 3


J00000423 TYLNJ 09608519-31 Kathleen G. Fallon - Deposition Ex. 63

J00000424 TYLNJ 01147409-10 Kathleen G. Fallon - Deposition Ex. 63A





J00000429 TYLNJ 001147368 Kathleen G. Fallon - Deposition Ex. 75


J00000431 TYLREP 01080705-09 Kathleen G. Fallon - Deposition Ex. 82


J00000433 Kathleen G. Fallon - Deposition Ex. 86A

J00000434 Kathleen G. Fallon - Deposition Ex. 86B



J00000437 Kathleen G. Fallon - Deposition Ex. 88 A



J00000440 TYLNJ 02314115-21 & TYLNJ 01151506-09 Kathleen G. Fallon - Deposition Ex. 400

J00000441 TYLREP01189245-46 Kathleen G. Fallon - Deposition Ex. 401





J00000446 Kathleen G. Fallon - Deposition Ex. 700A


5/22/2014 Deposition of Kathleen G. Fallon

Depositions - Company Witnesses


J00000448 Kathleen G. Fallon - Deposition Ex. 2B

J00000449 FITZ 08416-18 Kathleen G. Fallon - Deposition Ex. 6



J00000452 MATOS02544 Kathleen G. Fallon - Deposition Ex. 22

J00000453 MATTOS 02544-45 Kathleen G. Fallon - Deposition Ex. 22A

















6/5/2014 Deposition of Colleen Goggins

J00000470 TYLNJ 00561199-1202 Colleen Goggins - Deposition Ex. 1

J00000471 Colleen Goggins - Deposition Ex. 2





J00000476 TYLNJ 06882330 Colleen Goggins - Deposition Ex. 7







J00000483 TYL05-07 JCullen 03099-124 Colleen Goggins - Deposition Ex. 14






J00000489 TYLNJ 10588492-93-94 Colleen Goggins - Deposition Ex. 20






J00000495 TYLBGAFF 002769-73 Colleen Goggins - Deposition Ex. 26

















12/12/2013 Deposition of Patricia E. Gussin, MD

J00000511 Patricia E. Gussin, MD - Deposition Ex. P-50



J00000514 Patricia E. Gussin, MD - Deposition Ex. P-100A

J00000515 TYLNJ 03449514-15 Patricia E. Gussin, MD - Deposition Ex. P-101

J00000516 DOMKE I 001538-40 Patricia E. Gussin, MD - Deposition Ex. P-104


J00000518 DOMKE 035409-10 Patricia E. Gussin, MD - Deposition Ex. P-106

J00000519 MATTOS-03821-28 Patricia E. Gussin, MD - Deposition Ex. P-109


J00000521 MATTOS-07567-63 Patricia E. Gussin, MD - Deposition Ex. P-111

J00000522 FITZ 08416-18 Patricia E. Gussin, MD - Deposition Ex. P-112


J00000524 TYLREP00195249-65 Patricia E. Gussin, MD - Deposition Ex. P-114

J00000525 BOKA 000003572-73 Patricia E. Gussin, MD - Deposition Ex. P-115


J00000527 TYLNJ04032030_0001- _0002 Patricia E. Gussin, MD - Deposition Ex. P-117



J00000530 S020001 00375 Patricia E. Gussin, MD - Deposition Ex. P-121

J00000531 S020001 00152 & BOKA 000001407 Patricia E. Gussin, MD - Deposition Ex. P-122



J00000534 BOKA 000000164 Patricia E. Gussin, MD - Deposition Ex. P-127

J00000535 BOKA 000003498 Patricia E. Gussin, MD - Deposition Ex. P-128








3/26/2014 Deposition of Robert Z. Gussin, PhD

J00000543 NJTRANS00024460-61 Robert Z. Gussin, PhD - Deposition Ex. 5

J00000544 TYLNJ 03384948-49 Robert Z. Gussin, PhD - Deposition Ex. 6


J00000546 TYLNJ 03743589 Robert Z. Gussin, PhD - Deposition Ex. 15


J00000548 BOKA 000003572-73 Robert Z. Gussin, PhD - Deposition Ex. 17



J00000551 BOKA 000038851-54 Robert Z. Gussin, PhD - Deposition Ex. 25












J00000562 NJTYL_RGUSSIN_COMPENSATION Robert Z. Gussin, PhD - Deposition Ex. 56

J00000563 NJTYL-RGUSSIN_CV 1-10 Robert Z. Gussin, PhD - Deposition Ex. 57

J00000564 Robert Z. Gussin, PhD - Deposition Ex. 58

J00000565 Robert Z. Gussin, PhD - Deposition Ex. 62

10/31/2013 Deposition of Robert T. Havard

J00000566 Robert T. Havard - Deposition Ex. 30


J00000568 NJTRANS00007301-59 Robert T. Havard - Deposition Ex. 32

J00000569 TYLNJ 04200464-572 Robert T. Havard - Deposition Ex. 36


J00000571 BOKA 000006030-31 Robert T. Havard - Deposition Ex. 41












J00000583 S020001 00958 Robert T. Havard - Deposition Ex. 60


J00000585 BOKA 000002793-97 Robert T. Havard - Deposition Ex. 61A













2/5/2014 Deposition of Susan Hevey

J00000598 Susan Hevey - Deposition Ex. 210



J00000601 NJTYL_HEVEY_CV Susan Hevey - Deposition Ex. 213

J00000602 TYLNJ 03478153-57 Susan Hevey - Deposition Ex. 214



J00000605 LM007412-16 Susan Hevey - Deposition Ex. 217




J00000608 TYLNJ 07503221 Susan Hevey - Deposition Ex. 220









3/5/2014 Deposition of Edwin Kuffner, MD

J00000617 Edwin Kuffner, MD - Deposition Ex. 594





J00000622 TYLNJ 05879540-70 Edwin Kuffner, MD - Deposition Ex. 601






J00000628 TYLNJ 05879541/05879544 Edwin Kuffner, MD - Deposition Ex. 607

J00000629 TYLNJ 08718706-R-08-R Edwin Kuffner, MD - Deposition Ex. 608

J00000630 TYLNJ 08425315 Edwin Kuffner, MD - Deposition Ex. 609













J00000643 TYLNJ 08716450-R Edwin Kuffner, MD - Deposition Ex. 622








J00000650 BOKA 000018821-81 Edwin Kuffner, MD - Deposition Ex. 1107










J00000660 There is no Exhibit










J00000669 FITZ 08416-18 Edwin Kuffner, MD - Deposition Ex. 1156





J00000673 NJTYL_KUFFNER_COMPENSATION Edwin Kuffner, MD - Deposition Ex. 1029



J00000676 NJTYL_KUFFNER_CV Edwin Kuffner, MD - Deposition Ex. 1045

J00000677 Edwin Kuffner, MD - Deposition Ex. 1046A

J00000678 Edwin Kuffner, MD - Deposition Ex. 1046B

J00000679 Edwin Kuffner, MD - Deposition Ex. 1046C

J00000680 Edwin Kuffner, MD - Deposition Ex. 1046D

J00000681 Edwin Kuffner, MD - Deposition Ex. 1046E















1/25/2014 Deposition of Kenneth Kwong, MD, PhD

J00000696 LM005810-15 Kenneth Kwong, MD, PhD - Deposition Ex. 5


J00000698 LM005887-92 Kenneth Kwong, MD, PhD - Deposition Ex. 6A






J00000704 NJTYL_KWONG_CV Kenneth Kwong, MD, PhD - Deposition Ex. 180

J00000705 Kenneth Kwong, MD, PhD - Deposition Ex. 183


J00000707 TYLNJ 01943460-87 Kenneth Kwong, MD, PhD - Deposition Ex. 185


J00000709 TYLNJ 06038526-78 Kenneth Kwong, MD, PhD - Deposition Ex. 190

J00000710 MOT01233844-78 Kenneth Kwong, MD, PhD - Deposition Ex. 191

J00000711 TYLNJ01779519-24 Kenneth Kwong, MD, PhD - Deposition Ex. 192











2/12/2014 Deposition of Ashley A. McEvoy

J00000721 NJTYL_McEVOY_(MOTRIN) Ashley A. McEvoy - Deposition Ex. 1A

J00000722 NJTYL_McEVOY_CV Ashley A. McEvoy - Deposition Ex. 1B

J00000723 Ashley A. McEvoy - Deposition Ex. 2

J00000724 TYLNJ 01079255 Ashley A. McEvoy - Deposition Ex. 3


J00000726 TYLNJ 06278476 Ashley A. McEvoy - Deposition Ex. 4A

J00000727 Ashley A. McEvoy - Deposition Ex. 5A

J00000728 TYLNJ 06195744 Ashley A. McEvoy - Deposition Ex. 5C

J00000729 TYLNJ 02215103-11 Ashley A. McEvoy - Deposition Ex. 7


J00000731 TYLNJ 00557774 Ashley A. McEvoy - Deposition Ex. 7A-01










J00000741 Buc&Beardsley 000001-79 Ashley A. McEvoy - Deposition Ex. 41


J00000743 Buc&Beardsley 000092-100 Ashley A. McEvoy - Deposition Ex. 42







J00000750 TYLNJHC00000442-43 Ashley A. McEvoy - Deposition Ex. 74

J00000751 TYLNJ 05380557, TYLNJ 05380661, TYLNJ 05380597 Ashley A. McEvoy - Deposition Ex. 75

J00000752 MATOS02544 Ashley A. McEvoy - Deposition Ex. 86


J00000754 TYLREP01440568-71 Ashley A. McEvoy - Deposition Ex. 88A



J00000757 Ashley A. McEvoy - Deposition Ex. 110B

J00000758 Ashley A. McEvoy - Deposition Ex. 110C

J00000759 Ashley A. McEvoy - Deposition Ex. 110D

J00000760 Ashley A. McEvoy - Deposition Ex. 110E

J00000761 Ashley A. McEvoy - Deposition Ex. 110F

J00000762 Ashley A. McEvoy - Deposition Ex. 110G

J00000763 Ashley A. McEvoy - Deposition Ex. 110H

J00000764 Ashley A. McEvoy - Deposition Ex. 110I

J00000765 NJTYL_McEVOY_(MOTRIN) Ashley A. McEvoy - Deposition Ex. 200




11/21/2013 Deposition of Edward B. Nelson, MD, PhD

J00000768 Edward B. Nelson, MD, PhD - Deposition Ex. 60




J00000772 DO50002 0032 Edward B. Nelson, MD, PhD - Deposition Ex. 65

J00000773 TYLREP00194858-74 Edward B. Nelson, MD, PhD - Deposition Ex. 66

J00000774 TYLNJ 04471826-64 Edward B. Nelson, MD, PhD - Deposition Ex. 67



J00000777 TYLREP00195114-32 Edward B. Nelson, MD, PhD - Deposition Ex. 72













J00000790 TYLNJ 02353496 Edward B. Nelson, MD, PhD - Deposition Ex. 109




J00000794 FITZ 08416-18 Edward B. Nelson, MD, PhD - Deposition Ex. 174






J00000800 BOKA 000001123-24 Edward B. Nelson, MD, PhD - Deposition Ex. 196


J00000802 S020001 00430 Edward B. Nelson, MD, PhD - Deposition Ex. 201

J00000803 WALK 00123279-306 Edward B. Nelson, MD, PhD - Deposition Ex. 202










2/28/2014 Deposition of Lynn A. Pawelski

J00000813 Lynn A. Pawelski - Deposition Ex. D-1

J00000814 NJTYL_PAWELSKI_CV Lynn A. Pawelski - Deposition Ex. 1

J00000815 NJTRANS00009531, NJTRANS00009555-57,

NJTRANS00009562-63, NJTRANS00009571-72,

NJTRANS00009577, NJTRANS00009590-91,

NJTRANS00009616, NJTRANS00009692-94,

NJTRANS00009726-50

Lynn A. Pawelski - Deposition Ex. 3


J00000816 Lynn A. Pawelski - Deposition Ex. 4

J00000817 TYLNJ 03276622-69 Lynn A. Pawelski - Deposition Ex. 10









J00000826 Lynn A. Pawelski - Deposition Ex. 51A

J00000827 Lynn A. Pawelski - Deposition Ex. 51B

2/4/2014 Deposition of Steven Silber, MD

J00000828 Steven Silber, MD - Deposition Ex. S-1


J00000830 NJTYL_SILBER_CV Steven Silber, MD - Deposition Ex. S-3

J00000831 TYLNJ 08722543-52 Steven Silber, MD - Deposition Ex. S-4

J00000832 TYLNJ 08723781 Steven Silber, MD - Deposition Ex. S-5










J00000842 NJTRANS00000784-86 Steven Silber, MD - Deposition Ex. S-15

J00000843 FITZ 081416-18 Steven Silber, MD - Deposition Ex. S-16


J00000845 BOKA 000001125 Steven Silber, MD - Deposition Ex. S-18

J00000846 BOKA 000001123-24 Steven Silber, MD - Deposition Ex. S-19




J00000850 TYLNJ 05421304-05, 07, 08, 11-14 Steven Silber, MD - Deposition Ex. S-23

J00000851 TYLNJ 08722383 Steven Silber, MD - Deposition Ex. S-24

J00000852 TYLREP 01819080-81 Steven Silber, MD - Deposition Ex. S-25

J00000853 TYLREP 01819079 Steven Silber, MD - Deposition Ex. S-26

J00000854 TYLREP 01720910-57 Steven Silber, MD - Deposition Ex. S-27






















2/18/2014 Deposition of Anthony R. Temple, MD

J00000875 Anthony R. Temple, MD - Deposition Ex. 500

J00000876 BOKA 000006030 Anthony R. Temple, MD - Deposition Ex. 501



J00000879 NJTRANS00001349-51 Anthony R. Temple, MD - Deposition Ex. 504



J00000882 TYLNJ 03829397 Anthony R. Temple, MD - Deposition Ex. 507



J00000885 TYLREP00195249-65 Anthony R. Temple, MD - Deposition Ex. 510

J00000886 FITZ 08416 Anthony R. Temple, MD - Deposition Ex. 511


J00000888 NJTRANS00001733 Anthony R. Temple, MD - Deposition Ex. 513



J00000891 BOKA 000003574-81 Anthony R. Temple, MD - Deposition Ex. 516










J00000901 TYLNJ01310287-91 Anthony R. Temple, MD - Deposition Ex. 526





















J00000922 YANG 0024-71 Anthony R. Temple, MD - Deposition Ex. 547














J00000935 YANG 0001-412 Anthony R. Temple, MD - Deposition Ex. 560















J00000950 TYLNJ 02476169-71 Anthony R. Temple, MD - Deposition Ex. 575


J00000951 NJTYL_TEMPLE_COMPENSATION Anthony R. Temple, MD - Deposition Ex. 851

J00000952 NJTYL_TEMPLE_CONSULTINGAGREEMENT Anthony R. Temple, MD - Deposition Ex. 852







J00000959 Anthony R. Temple, MD - Deposition Ex. 863A



J00000962 LM007412-16 Anthony R. Temple, MD - Deposition Ex. 871









J00000971 TYLNJ 02488423-33, TYLNJ 02488438-57 Anthony R. Temple, MD - Deposition Ex. 890





J00000976 NJTRANS00016134, NJTRANS00016100 Anthony R. Temple, MD - Deposition Ex. 915


J00000977 NJTRANS00026947, NJTRANS00012900, NEWTON

03608, NJTRANS00014504, NJTRANS00013137,

NJTRANS00013412, NEWTON 03482,

NJTRANS00011366, NJTRANS00023274,

NJTRANS00011724, NJTRANS00023866

Anthony R. Temple, MD - Deposition Ex. 916








J00000984 MATTOS-04665 Anthony R. Temple, MD - Deposition Ex. 936























J00001007 TYLNJ 04318065-66, TYLNJ 04318084 Anthony R. Temple, MD - Deposition Ex. 1015




5/19/2015 Deposition of Christina Tonielli

J00001010 Christina Tonielli - Deposition Ex. 5000







5/19/2015 Deposition of John Duke

J00001017 John Duke - Deposition Ex. 4000










5/2/2014 Deposition of Sarah C. Erush, PharmD

J00001100 Sarah C. Erush, PharmD - Deposition Ex. 1








7/30/2014 Deposition of Jennifer Bailey

J00001108 Jennifer Bailey - Deposition Ex. 7

J00001109 Jennifer Bailey - Deposition Ex. 5

4/22/2016 Deposition of Anne M. Larson, MD

J00001110 Anne Larson - Defendant Deposition Ex. 1




















J00001130 Anne Larson - Plaintiff Deposition Ex. 1









4/18/2016 Deposition of Patricia R. Robuck, PhD

J00001139 Patricia Robuck - Deposition Ex. 1







4/14/2016 Deposition of William M. Lee, MD

Depositions - Third Party Witnesses


J00001146 William M. Lee, MD - Defendant Deposition Ex. 1















J00001161 William M. Lee, MD - Defendant Deposition Ex. 17A

J00001162 William M. Lee, MD - Defendant Deposition Ex. 17B


J00001164 William M. Lee, MD - Plaintiff Deposition Ex. 1



























J00001200 5/5/2014 Expert Report of Cheryl D. Blume, PhD and Reference

Materials Listed

J00001201 Curriculum Vitae of Cheryl D. Blume, PhD

6/13/2014 Deposition of Cheryl D. Blume, PhD

J00001202 Cheryl D. Blume, PhD - Deposition Ex. # 1





Plaintiff's Experts






J00001211 5/5/2014 Expert Report of Marvin E. Goldberg, PhD and Reference

Materials Listed

J00001212 Curriculum Vitae of Marvin E. Goldberg, PhD

J00001213 6/2/2014 Supplemental Expert Report of Marvin E. Goldberg, PhD

and Reference Materials Listed

6/6/2014 Deposition of Marvin E. Goldberg, PhD

J00001214 Marvin E. Goldberg, PhD - Deposition Ex. 1








J00001222 TYLNJ 10587239 Marvin E. Goldberg, PhD - Deposition Ex. 9




J00001226 2/4/2015 Expert Report of Marvin E. Goldberg, PhD and Reference

Materials Listed

J00001227 5/5/2014 Expert Report of Neil Kaplowitz, MD and Reference

Materials Listed

J00001228 Curriculum Vitae of Neil Kaplowitz, MD

J00001229 2/16/2015 Supplemental Expert Report of Neil Kaplowitz, M.D. and

Reference Materials Listed

6/3/2014 Deposition of Neil Kaplowitz, MD

J00001230 Neil Kaplowitz, MD - Deposition Ex. 1












J00001242 TYLREP01015553-662, TYLNJ 09267591-97 Neil Kaplowitz, MD - Deposition Ex. 13









4/21/2015 Deposition of Neil Kaplowitz, MD

































J00001282 4/30/2014 Expert Report of Robert C. Nelson, PhD, FISPE and


J00001283 Curriculum Vitae of Robert C. Nelson, PhD, FISPE

5/22/2014 Deposition of Robert C. Nelson, PhD, FISPE

J00001284 Robert C. Nelson, PhD - Deposition Ex. 1





J00001289 C100038 0019-0184 Robert C. Nelson, PhD - Deposition Ex. 6

J00001290 TYLREP01067819-23 Robert C. Nelson, PhD - Deposition Ex. 7

J00001291 TYLNJ 08195470-569 Robert C. Nelson, PhD - Deposition Ex. 8


















J00001308 TYLNJ 03455964-69, BENEDI 003434-35, DOMKE

035060-65

Robert C. Nelson, PhD - Deposition Ex. 25



J00001311 Robert C. Nelson, PhD - Deposition Ex. 27A


4/8/2015 Deposition of Robert C. Nelson, PhD, FISPE












J00001324 5/2/2014 Expert Report of Laura M. Plunkett, PhD, DABT and


J00001325 Curriculum Vitae of Laura M. Plunkett, PhD, DABT

J00001326 2/13/2015 Supplemental Expert Report of Laura M. Plunkett, PhD,

DABT and Reference Materials Listed





J00001329 Plunkett Invoices since April 2015 Deposition

5/27/2014 Deposition of Laura M. Plunkett, PhD

J00001330 Laura M. Plunkett, PhD - Deposition Ex. 1













J00001343 TYLREP01015552-662 Laura M. Plunkett, PhD - Deposition Ex. 14

J00001344 TYLNJ 01942866-92, TYLNJ 06591617-20, TYLNJ

05751608-15

Laura M. Plunkett, PhD - Deposition Ex. 15




























































J00001401 Cheryl D. Blume - Invoices

J00001402 2/16/2015 Expert Report of Timothy J. Davern II, MD and Reference

Materials Listed

J00001403 Curriculum Vitae of Timothy J. Davern II, MD

J00001404 3/18/2016 Supplemental Expert Report of Timothy J. Davern II, MD


3/28/2015 Deposition of Timothy J. Davern II, MD

J00001405 Timothy J. Davern II, MD - Deposition Ex. 1
































4/20/2016 Deposition of Timothy J. Davern II, MD




















J00001455 7/5/2014 Affidavit of Gerald M. Rachanow, Esq.

J00001456 8/18/2014 Supplemental Affidavit of Gerald M. Rachanow, Esq.

J00001457 Curriculum Vitae of Gerald M. Rachanow, Esq.

4/27/2015 Deposition of Gerald M. Rachanow, Esq.

J00001458 Gerald M. Rachanow, Esq. - Deposition Ex. 1






























J00001487 2/16/2015 Expert Report of Craig E. Smith, MD with Reference

Materials Listed

J00001488 Curriculum Vitae of Craig E. Smith, MD

4/17/2015 Deposition of Craig E. Smith, MD

J00001489 Craig E. Smith, MD - Deposition Ex. 1











J00001500 5/19/2014 Expert Report of Douglas Ws. Bierer, PhD and Reference

Materials Listed

J00001501 Curriculum Vitae of Douglas Ws. Bierer, PhD

J00001502 6/26/2014 Deposition of Douglas Ws. Bierer, PhD

J00001503 Douglas Ws. Bierer, PhD - Deposition Ex. 1







Defendant's Experts








J00001516 TYLNJ 04274652 Douglas Ws. Bierer, PhD - Deposition Ex. 14





J00001521 TYLNJ 02595999-6078 Douglas Ws. Bierer, PhD - Deposition Ex. 19










J00001531 Expert Report of Jeffrey Brent, MD, PhD and Reference

Materials Listed

J00001532 2/4/2014 Curriculum of Jeffrey Brent, MD, PhD

6/6/2014 Deposition of Jeffrey Brent, MD, PhD

J00001533 Jeffrey Brent, MD, PhD - Deposition Ex. 1


J00001535 HORNSBY 001041 Jeffrey Brent, MD, PhD - Deposition Ex. 3



J00001538 TYLREP01015554 Jeffrey Brent, MD, PhD - Deposition Ex. 6

J00001539 TYLNJ 03278924-76 Jeffrey Brent, MD, PhD - Deposition Ex. 7

J00001540 TYLNJ 03276622-69 Jeffrey Brent, MD, PhD - Deposition Ex. 7A





J00001545 TYLNJ 04465472-74 Jeffrey Brent, MD, PhD - Deposition Ex. 12

J00001546 TYLNJ-MEDWATCH-KLEMON_00000001-08 Jeffrey Brent, MD, PhD - Deposition Ex. 13

J00001547 4/27/2015 Expert Report of Jeffrey Brent, MD, PhD and Reference

Materials Listed

J00001548 1/28/2016 Supplemental Expert Report of Jeffrey Brent, MD, PhD


J00001549 5/8/2015 Deposition of Jeffrey Brent, MD, PhD




J00001553 Jeffrey Brent, MD, PhD - Deposition Ex. 3A














J00001566 3/30/2016 Deposition of Jeffrey Brent, MD, PhD










J00001576 3/26/2015 Expert Report of Robert S. Brown, Jr., MD, MPH and


J00001577 Curriculum Vitae of Robert S. Brown, Jr., MD, MPH

J00001578 4/30/2015 Deposition of Robert S. Brown, Jr., MD, MPH

J00001579 Robert S. Brown, Jr., MD, MPH - Deposition Ex. 1

J00001580 Robert S. Brown, Jr., MD, MPH - Deposition Ex. 1A






















J00001602 1/28/2016 Supplemental Expert Report of Robert S. Brown, Jr., MD,

MPH and Reference Materials Listed

J00001603 3/26/2015 Expert Report of Steven L. Flamm, MD and Reference

Materials Listed

J00001604 Curriculum Vitae of Steven L. Flamm, MD

5/5/2015 Deposition of Steven L. Flamm, MD

J00001605 Steven L. Flamm, MD - Deposition Ex. 1
























J00001628 1/28/2016 Supplemental Expert Report of Steven L. Flamm, MD


4/8/2016 Deposition of Steven L. Flamm, MD










J00001638 3/26/2015 Expert Report of Alan E. Jones, MD, FACEP

J00001639 Curriculum Vitae of Alan E. Jones, MD, FACEP

5/15/2015 Deposition of Alan E. Jones, MD, FACEP

J00001640 Alan E. Jones, MD, FACEP - Deposition Ex. 1















J00001655 3/27/2015 Expert Report of Judith K. Jones, MD, PhD



J00001658 Curriculum Vitae of Judith K. Jones, MD, PhD

5/5/2015 Deposition of Judith K. Jones, MD, PhD

J00001659 Judith K. Jones, MD, PhD - Deposition Ex. 1













J00001671 5/19/2014 Expert Report of Louis A. Morris, PhD and Reference

Materials Listed

J00001672 Curriculum Vitae of Louis A. Morris, PhD

6/26/2014 Deposition of Louis A. Morris, PhD

J00001673 Louis A. Morris, MD - Deposition Ex. 1










J00001683 3/6/2015 Expert Report of Louis A. Morris, PhD and Reference

Materials Listed

J00001684 5/19/2014 Expert Report of James J. Schlesselman, PhD and


J00001685 5/0/2014 Curriculum Vitae of James J. Schlesselman, PhD

6/27/2014 Deposition of James J. Schlesselman, PhD

J00001686 James J. Schlesselman, PhD - Deposition Ex. 1













J00001699 TYLNJ 01942865-92 James J. Schlesselman, PhD - Deposition Ex. 25






J00001705 3/26/2015 Expert Report of James J. Schlesselman, PhD and


J00001706 3/22/2015 Expert Report of Gordon Sze, MD and Reference

Materials Listed

Curriculum Vitae of Gordon Sze, MD

J00001707 5/11/2015 Deposition of Gordon Sze, MD

J00001708 Gordon Sze, MD - Deposition Ex. 1




IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN ... · 2016, with a list of witnesses, exhibits...

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Transcript of IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN ... · 2016, with a list of witnesses, exhibits...