Application 211479
- Type
- ANDA
- Sponsor
- MSN LABS PVT LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAPAGLIFLOZIN | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 5MG; 500MG | No | No |
| 002 | DAPAGLIFLOZIN | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 5MG; 1GM | No | No |
| 003 | DAPAGLIFLOZIN | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 10MG; 500MG | No | No |
| 004 | DAPAGLIFLOZIN | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 10MG; 1GM | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63420 | ORIG | 2020-06-04 |