Application 207378
- Type
- ANDA
- Sponsor
- INVAGEN PHARMS
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-739 | Fenofibrate | fenofibrate | Northstar Rx LLC | ANDA | Current |
| 16714-739 | Fenofibrate | fenofibrate | Northstar Rx LLC | ANDA | Current |
| 16714-739 | Fenofibrate | fenofibrate | Northstar Rx LLC | ANDA | Current |
| 16714-740 | Fenofibrate | fenofibrate | Northstar Rx LLC | ANDA | Current |
| 16714-740 | Fenofibrate | fenofibrate | Northstar Rx LLC | ANDA | Current |
| 16714-740 | Fenofibrate | fenofibrate | Northstar Rx LLC | ANDA | Current |
| 16714-741 | Fenofibrate | fenofibrate | Northstar Rx LLC | ANDA | Current |
| 16714-741 | Fenofibrate | fenofibrate | Northstar Rx LLC | ANDA | Current |
| 16714-741 | Fenofibrate | fenofibrate | Northstar Rx LLC | ANDA | Current |
| 50090-4698 | Fenofibrate | fenofibrate | A-S Medication Solutions | ANDA | Current |
| 50090-4698 | Fenofibrate | fenofibrate | A-S Medication Solutions | ANDA | Current |
| 68071-4088 | Fenofibrate | fenofibrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 69097-894 | Fenofibrate | fenofibrate | Cipla USA Inc., | ANDA | Current |
| 69097-894 | Fenofibrate | fenofibrate | Cipla USA Inc., | ANDA | Current |
| 69097-894 | Fenofibrate | fenofibrate | Cipla USA Inc., | ANDA | Current |
| 69097-895 | Fenofibrate | fenofibrate | Cipla USA Inc., | ANDA | Current |
| 69097-895 | Fenofibrate | fenofibrate | Cipla USA Inc., | ANDA | Current |
| 69097-895 | Fenofibrate | fenofibrate | Cipla USA Inc., | ANDA | Current |
| 69097-896 | Fenofibrate | fenofibrate | Cipla USA Inc., | ANDA | Current |
| 69097-896 | Fenofibrate | fenofibrate | Cipla USA Inc., | ANDA | Current |
| 69097-896 | Fenofibrate | fenofibrate | Cipla USA Inc., | ANDA | Current |