Drugs@FDA document
AMBRISENTAN REMS · ANDA 208441 APPL-0
Drugs@FDA document · MYLAN · Apr 1, 2019
Key facts
| Drug name | AMBRISENTAN |
|---|---|
| Document type | REMS |
| Application | ANDA208441 |
| Submission | APPL-0 |
| Company | MYLAN |
| Document date | Apr 1, 2019 |
| FDA document | accessdata.fda.gov |
At a glance
- 10–99 Documents for this application
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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: