Application 200815
- Type
- ANDA
- Sponsor
- VINTAGE PHARMS LLC
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 |
|---|
| 0603-3581 | Felodipine | Felodipine | Par Pharmaceutical | ANDA | Current |
| 0603-3581 | Felodipine | Felodipine | Par Pharmaceutical | ANDA | Current |
| 0603-3581 | Felodipine | Felodipine | Par Pharmaceutical, Inc. | ANDA | Current |
| 0603-3582 | Felodipine | Felodipine | Par Pharmaceutical, Inc. | ANDA | Current |
| 0603-3582 | Felodipine | Felodipine | Par Pharmaceutical | ANDA | Current |
| 0603-3582 | Felodipine | Felodipine | Par Pharmaceutical | ANDA | Current |
| 0603-3583 | Felodipine | Felodipine | Par Pharmaceutical, Inc. | ANDA | Current |
| 0603-3583 | Felodipine | Felodipine | Par Pharmaceutical | ANDA | Current |
| 0603-3583 | Felodipine | Felodipine | Par Pharmaceutical | ANDA | Current |
| 63629-2191 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2191 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2192 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2192 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2193 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2193 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2194 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2194 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2195 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2195 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2196 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |
| 63629-2196 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |