Drugs@FDA document
DARUNAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR ALAFENAMIDE Letter · ANDA 216511 ORIG-1
Drugs@FDA document · LUPIN LTD · Feb 19, 2025
Key facts
| Drug name | DARUNAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR ALAFENAMIDE |
|---|---|
| Document type | Letter |
| Application | ANDA216511 |
| Submission | ORIG-1 |
| Company | LUPIN LTD |
| Document date | Feb 19, 2025 |
| FDA document | accessdata.fda.gov |
At a glance
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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: