Application 212373
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 5MG;500MG | No | No |
| 002 | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 5MG;1000MG | No | No |
| 003 | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 12.5MG;500MG | No | No |
| 004 | EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 12.5MG;1000MG | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.