Application 205118
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|
| 16714-737 | Fenofibrate | Fenofibrate | NorthStar Rx LLC | ANDA | Current |
| 16714-737 | Fenofibrate | Fenofibrate | NorthStar Rx LLC | ANDA | Current |
| 16714-737 | Fenofibrate | Fenofibrate | NorthStar Rx LLC | ANDA | Current |
| 16714-737 | Fenofibrate | Fenofibrate | NorthStar Rx LLC | ANDA | Current |
| 16714-738 | Fenofibrate | Fenofibrate | NorthStar Rx LLC | ANDA | Current |
| 16714-738 | Fenofibrate | Fenofibrate | NorthStar Rx LLC | ANDA | Current |
| 16714-738 | Fenofibrate | Fenofibrate | NorthStar Rx LLC | ANDA | Current |
| 16714-738 | Fenofibrate | Fenofibrate | NorthStar Rx LLC | ANDA | Current |
| 50090-3887 | Fenofibrate | Fenofibrate | A-S Medication Solutions | ANDA | Current |
| 50090-3887 | Fenofibrate | Fenofibrate | A-S Medication Solutions | ANDA | Current |
| 50090-4957 | Fenofibrate | Fenofibrate | A-S Medication Solutions | ANDA | Current |
| 65862-768 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-768 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-768 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-768 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-768 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-769 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-769 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-769 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-769 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-769 | Fenofibrate | Fenofibrate | Aurobindo Pharma Limited | ANDA | Current |
| 68071-2369 | Fenofibrate | Fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4297 | Fenofibrate | Fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4486 | Fenofibrate | Fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4983 | Fenofibrate | Fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4983 | Fenofibrate | Fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-2768 | Fenofibrate | Fenofibrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2768 | Fenofibrate | Fenofibrate | REMEDYREPACK INC. | ANDA | Current |
| 71335-1701 | Fenofibrate | Fenofibrate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1701 | Fenofibrate | Fenofibrate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1701 | Fenofibrate | Fenofibrate | Bryant Ranch Prepack | ANDA | Current |
| 82009-060 | Fenofibrate | Fenofibrate | QUALLENT PHARMACEUTICALS HEALTH LLC | ANDA | Current |