Drugs@FDA document
HYDROCODONE BITARTRATE AND IBUPROFEN REMS · ANDA 076642 ORIG-1
Drugs@FDA document · AMNEAL PHARMS NY · Nov 2, 2023
Key facts
| Drug name | HYDROCODONE BITARTRATE AND IBUPROFEN |
|---|---|
| Document type | REMS |
| Application | ANDA076642 |
| Submission | ORIG-1 |
| Company | AMNEAL PHARMS NY |
| Document date | Nov 2, 2023 |
| FDA document | web.archive.org |
At a glance
- 1–9 Documents for this application
- None USP chapters cited in this application's documents
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About Drugs@FDA documents
Drugs@FDA posts the letters, labels, reviews and other documents behind each drug application and supplement. Orca1 indexes every document's full text and flags complete response letters.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA application documents · Source date: