Application 201964
- Type
- ANDA
- Sponsor
- HERITAGE PHARMS INC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FELODIPINE | FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 2.5MG | No | No |
| 002 | FELODIPINE | FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 003 | FELODIPINE | FELODIPINE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 23155-048 | Felodipine | Felodipine | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-048 | FELODIPINE | FELODIPINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-049 | Felodipine | Felodipine | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-049 | FELODIPINE | FELODIPINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-050 | Felodipine | Felodipine | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-050 | FELODIPINE | FELODIPINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |