Application 090365
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
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 |
|---|---|---|---|---|---|
| 45865-445 | Felodipine | Felodipine | Medsource Pharmaceuticals | ANDA | Current |
| 50090-2421 | Felodipine | Felodipine | A-S Medication Solutions | ANDA | Current |
| 68151-3084 | Felodipine | Felodipine | Carilion Materials Management | ANDA | Current |
| 68462-233 | Felodipine | Felodipine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-234 | Felodipine | Felodipine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-235 | Felodipine | Felodipine | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 71335-1486 | Felodipine | Felodipine | Bryant Ranch Prepack | ANDA | Current |