Application 213450
- Type
- ANDA
- Sponsor
- MICRO LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE | CAPSULE, DELAYED RELEASE;ORAL | EQ 45MG FENOFIBRIC ACID | No | No |
| 002 | FENOFIBRIC ACID | CHOLINE FENOFIBRATE | CAPSULE, DELAYED RELEASE;ORAL | EQ 135MG FENOFIBRIC ACID | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42571-347 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-347 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-347 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-347 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-347 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-347 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-348 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-348 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-348 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-348 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-348 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |
| 42571-348 | Fenofibric acid | Fenofibric acid | Micro Labs Limited | ANDA | Current |