Application 212362
- Type
- ANDA
- Sponsor
- MSN LABS PVT LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 5MG/1000MG | No | No |
| 002 | EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 10MG/1000MG | No | No |
| 003 | EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 12.5MG/1000MG | No | No |
| 004 | EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 25MG/1000MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73406 | ORIG | 2023-02-08 |