Application 207427
- Type
- ANDA
- Sponsor
- BEXIMCO PHARMS USA
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 |
|---|
| 71610-554 | Metformin hydrochloride | Metformin hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-554 | Metformin hydrochloride | Metformin hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-554 | Metformin hydrochloride | Metformin hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-587 | Metformin hydrochloride | Metformin hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-587 | Metformin hydrochloride | Metformin hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-666 | Metformin hydrochloride | Metformin hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72789-105 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-105 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-105 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-105 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-105 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-106 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-106 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-106 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-106 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-106 | Metformin hydrochloride | Metformin hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 76385-128 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-128 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-128 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-128 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-128 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-129 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-129 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-129 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-129 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |
| 76385-129 | Metformin hydrochloride | Metformin hydrochloride | Bayshore Pharmaceuticals LLC | ANDA | Current |