Application 213344
- Type
- ANDA
- Sponsor
- GRANULES
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 |
|---|---|---|---|---|---|
| 62207-496 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-496 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-496 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-496 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-497 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-497 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-497 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules India Ltd | ANDA | Current |
| 62207-497 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules India Ltd | ANDA | Current |
| 70010-496 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-497 | METFORMIN HYDROCHLORIDE | Metformin Hydrochloride | Granules Pharmaceuticals Inc. | ANDA | Current |