Drug application
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE (EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE)
Drugs@FDA ANDA 215873 · SUN PHARM INDS LTD
Key facts
| Drug name | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
|---|---|
| Active ingredients | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
| Application type | ANDA |
| Application number | 215873 |
| Company | SUN PHARM INDS LTD |
| Dosage forms | TABLET, ORAL |
| Strength | 12.5MG/1000MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | Oct 24, 2023 |
At a glance
- 1–9 Submissions
- None Label versions
- None Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.