Application 090715
- Type
- ANDA
- Sponsor
- VALEANT PHARMS NORTH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FENOFIBRATE | FENOFIBRATE | TABLET;ORAL | 48MG | No | No |
| 002 | FENOFIBRATE | FENOFIBRATE | TABLET;ORAL | 145MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45802-132 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 45802-132 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 45802-132 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 45802-132 | fenofibrate | fenofibrate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-132 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 45802-132 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 45802-315 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 45802-315 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 45802-315 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 45802-315 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 45802-315 | fenofibrate | fenofibrate | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-315 | fenofibrate | fenofibrate | Perrigo New York Inc | ANDA | Current |
| 50090-2459 | fenofibrate | fenofibrate | A-S Medication Solutions | ANDA | Current |
| 50090-2692 | fenofibrate | fenofibrate | A-S Medication Solutions | ANDA | Current |
| 68071-3114 | fenofibrate | fenofibrate | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3114 | fenofibrate | fenofibrate | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4182 | fenofibrate | fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4182 | fenofibrate | fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4265 | fenofibrate | fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4320 | fenofibrate | fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4320 | fenofibrate | fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4358 | fenofibrate | fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4358 | fenofibrate | fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7254 | fenofibrate | fenofibrate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7254 | fenofibrate | fenofibrate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7254 | fenofibrate | fenofibrate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-050 | fenofibrate | fenofibrate | Proficient Rx LP | ANDA | Current |
| 71205-050 | fenofibrate | fenofibrate | Proficient Rx LP | ANDA | Current |
| 71335-0578 | fenofibrate | fenofibrate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0578 | fenofibrate | fenofibrate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0903 | fenofibrate | fenofibrate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0903 | fenofibrate | fenofibrate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0903 | fenofibrate | fenofibrate | Bryant Ranch Prepack | ANDA | Current |
| 71610-027 | fenofibrate | fenofibrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |