Application 213651
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
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 | 1GM | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27241-188 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-188 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-188 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-189 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-189 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma Limited | ANDA | Current |
| 27241-189 | Metformin hydrochloride | Metformin hydrochloride | Ajanta Pharma USA Inc. | ANDA | Current |