Application 076756
- Type
- ANDA
- Sponsor
- NOSTRUM PHARMS LLC
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 29033-018 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Nostrum Laboratories Inc. | ANDA | Current |
| 29033-021 | Metformin Hydrochloride | METFORMIN HYDROCHLORIDE | Nostrum Laboratories Inc. | ANDA | Current |
| 29033-055 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Nostrum Laboratories Inc. | ANDA | Current |
| 29033-056 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Nostrum Laboratories Inc. | ANDA | Current |
| 63629-9146 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-9146 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-9147 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |
| 63629-9147 | METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | Bryant Ranch Prepack | ANDA | Current |