Application 091484
- Type
- ANDA
- Sponsor
- WOCKHARDT LTD
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 |
|---|---|---|---|---|---|
| 55648-411 | FELODIPINE | FELODIPINE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-412 | FELODIPINE | FELODIPINE | WOCKHARDT LIMITED | ANDA | Current |
| 55648-414 | FELODIPINE | FELODIPINE | WOCKHARDT LIMITED | ANDA | Current |
| 64679-411 | FELODIPINE | felodipine | Wockhardt USA LLC. | ANDA | Current |
| 64679-411 | FELODIPINE | felodipine | Wockhardt USA LLC. | ANDA | Current |
| 64679-412 | FELODIPINE | felodipine | Wockhardt USA LLC. | ANDA | Current |
| 64679-412 | FELODIPINE | felodipine | Wockhardt USA LLC. | ANDA | Current |
| 64679-414 | FELODIPINE | felodipine | Wockhardt USA LLC. | ANDA | Current |
| 64679-414 | FELODIPINE | felodipine | Wockhardt USA LLC. | ANDA | Current |