Application 075896
- Type
- ANDA
- Sponsor
- SUN PHARM INDUSTRIES
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-1125 | Felodipine | Felodipine | A-S Medication Solutions | ANDA | Current |
| 53489-368 | Felodipine | Felodipine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-368 | Felodipine | Felodipine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-369 | Felodipine | Felodipine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-369 | Felodipine | Felodipine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-370 | Felodipine | Felodipine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 53489-370 | Felodipine | Felodipine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 55289-306 | Felodipine | Felodipine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4466 | Felodipine | Felodipine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68151-3083 | Felodipine | Felodipine | Carilion Materials Management | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22514 | ORIG | 2007-11-19 |
| 31045 | ORIG | 2004-11-08 |