Application 200913
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
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 |
|---|---|---|---|---|---|
| 0378-2589 | Fenofibric Acid | fenofibric acid | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2589 | Fenofibric Acid | fenofibric acid | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2589 | Fenofibric Acid | fenofibric acid | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2590 | Fenofibric Acid | fenofibric acid | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2590 | Fenofibric Acid | fenofibric acid | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2590 | Fenofibric Acid | fenofibric acid | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32072 | ORIG | 2013-03-28 |