Application 202579
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 43MG | No | No |
| 002 | FENOFIBRATE (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 130MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-6088 | Fenofibrate | fenofibrate | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-6088 | Fenofibrate | fenofibrate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6089 | Fenofibrate | fenofibrate | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-6089 | Fenofibrate | fenofibrate | Mylan Pharmaceuticals Inc. | ANDA | Current |