Application 205566
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 67MG | No | No |
| 002 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 134MG | No | No |
| 003 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 200MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50090-6120 | fenofibrate | fenofibrate | A-S Medication Solutions | ANDA | Current |
| 60687-713 | Fenofibrate | Fenofibrate | American Health Packaging | ANDA | Current |
| 68462-580 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-580 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-580 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-580 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-580 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-580 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-581 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-581 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-581 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-581 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-581 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-581 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-582 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-582 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-582 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-582 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-582 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-582 | fenofibrate | fenofibrate | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |