Application 203755
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
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 | 1GM | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-2411 | Metformin Hydrochloride | Metformin Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2411 | Metformin Hydrochloride | Metformin Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2411 | Metformin Hydrochloride | Metformin Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2412 | Metformin Hydrochloride | Metformin Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2412 | Metformin Hydrochloride | Metformin Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-2412 | Metformin Hydrochloride | Metformin Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 42291-558 | Metformin Hydrochloride | Metformin Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-558 | Metformin Hydrochloride | Metformin Hydrochloride | AvKARE | ANDA | Current |
| 42291-559 | Metformin Hydrochloride | Metformin Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-559 | Metformin Hydrochloride | Metformin Hydrochloride | AvKARE | ANDA | Current |
| 70518-0973 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0973 | Metformin Hydrochloride | Metformin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |