Drugs@FDA document
AMIODARONE HYDROCHLORIDE Letter · ANDA 075761 ORIG-1
Drugs@FDA document · FRESENIUS KABI USA · Apr 15, 2003
Key facts
| Drug name | AMIODARONE HYDROCHLORIDE |
|---|---|
| Document type | Letter |
| Application | ANDA075761 |
| Submission | ORIG-1 |
| Company | FRESENIUS KABI USA |
| Document date | Apr 15, 2003 |
| FDA document | accessdata.fda.gov |
At a glance
- 10–99 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: