APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND...
Transcript of APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND...
![Page 1: APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 05-213/S023 CONTENTS Reviews / Information Included in](https://reader031.fdocuments.net/reader031/viewer/2022041704/5e43bcd3b3c9896eb6725ae9/html5/thumbnails/1.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
Approval Package for:
APPLICATION NUMBER:
05-213/S023
Trade Name:
Hycodan
Generic Name:
homatropine methylbromide; hydrocodone bitartrate
Sponsor:
DuPont
Approval Date:
11/08/1988
![Page 2: APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 05-213/S023 CONTENTS Reviews / Information Included in](https://reader031.fdocuments.net/reader031/viewer/2022041704/5e43bcd3b3c9896eb6725ae9/html5/thumbnails/2.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
05-213/S023
CONTENTS
Reviews / Information Included in this NDA Review.
Approval Letter Other Action Letters Labeling REMS Summary Review Officer/Employee List Office Director Memo Cross Discipline Team Leader Review Medical Review(s) Chemistry Review(s) Environmental Assessment Pharmacology Review(s) Statistical Review(s) Microbiology Review(s) Clinical Pharmacology/Biopharmaceutics Review(s) Other Reviews Risk Assessment and Risk Mitigation Review(s) Proprietary Name Review(s) Administrative/Correspondence Document(s)
![Page 3: APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 05-213/S023 CONTENTS Reviews / Information Included in](https://reader031.fdocuments.net/reader031/viewer/2022041704/5e43bcd3b3c9896eb6725ae9/html5/thumbnails/3.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
05-213/S023
APPROVAL LETTER
![Page 4: APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 05-213/S023 CONTENTS Reviews / Information Included in](https://reader031.fdocuments.net/reader031/viewer/2022041704/5e43bcd3b3c9896eb6725ae9/html5/thumbnails/4.jpg)
![Page 5: APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 05-213/S023 CONTENTS Reviews / Information Included in](https://reader031.fdocuments.net/reader031/viewer/2022041704/5e43bcd3b3c9896eb6725ae9/html5/thumbnails/5.jpg)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER:
05-213/S023
CHEMISTRY REVIEW(S)
![Page 6: APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 05-213/S023 CONTENTS Reviews / Information Included in](https://reader031.fdocuments.net/reader031/viewer/2022041704/5e43bcd3b3c9896eb6725ae9/html5/thumbnails/6.jpg)
![Page 7: APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 05-213/S023 CONTENTS Reviews / Information Included in](https://reader031.fdocuments.net/reader031/viewer/2022041704/5e43bcd3b3c9896eb6725ae9/html5/thumbnails/7.jpg)
![Page 8: APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 05-213/S023 CONTENTS Reviews / Information Included in](https://reader031.fdocuments.net/reader031/viewer/2022041704/5e43bcd3b3c9896eb6725ae9/html5/thumbnails/8.jpg)
![Page 9: APPLICATION NUMBER: 05-213/S023 - Food and Drug Administration · CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 05-213/S023 CONTENTS Reviews / Information Included in](https://reader031.fdocuments.net/reader031/viewer/2022041704/5e43bcd3b3c9896eb6725ae9/html5/thumbnails/9.jpg)