Application 211491
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;1GM | No | No |
| 002 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG;500MG | No | No |
| 003 | DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG;1GM | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 60240 | ORIG | 2019-10-04 |