Drugs@FDA document
OXYBUTYNIN CHLORIDE Review · ANDA 078503 ORIG-1
Drugs@FDA document · OSMOTICA PHARM US · Aug 9, 2013
Key facts
| Drug name | OXYBUTYNIN CHLORIDE |
|---|---|
| Document type | Review |
| Application | ANDA078503 |
| Submission | ORIG-1 |
| Company | OSMOTICA PHARM US |
| Document date | Aug 9, 2013 |
| FDA document | accessdata.fda.gov |
At a glance
- 1–9 Documents for this application
- 1–9 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: