Drugs@FDA document
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE Label · ANDA 211563 ORIG-2
Drugs@FDA document · ALKEM LABS LTD · May 26, 2026
Key facts
| Drug name | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE |
|---|---|
| Document type | Label |
| Application | ANDA211563 |
| Submission | ORIG-2 |
| Company | ALKEM LABS LTD |
| Document date | May 26, 2026 |
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: