Application 211582
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAPAGLIFLOZIN | DAPAGLIFLOZIN | TABLET;ORAL | 5MG | No | No |
| 002 | DAPAGLIFLOZIN | DAPAGLIFLOZIN | TABLET;ORAL | 10MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65508 | ORIG | 2020-12-07 |