Application 217049
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG;2.5MG;1000MG | No | No |
| 002 | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG;5MG;1000MG | No | No |
| 003 | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 12.5MG;2.5MG;1000MG | No | No |
| 004 | EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 25MG;5MG;1000MG | No | No |