Application 213359
- Type
- ANDA
- Sponsor
- UNICHEM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 500MG | No | No |
| 002 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 750MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29300-389 | Metformin Hydrochloride | Metformin Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-389 | Metformin Hydrochloride | Metformin Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-399 | Metformin Hydrochloride | Metformin Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-399 | Metformin Hydrochloride | Metformin Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |