Application 077578
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FINASTERIDE | FINASTERIDE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5036 | Finasteride | finasteride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-321 | Finasteride | finasteride | Mylan Institutional Inc. | ANDA | Current |
| 55154-4396 | Finasteride | finasteride | Cardinal Health | ANDA | Current |
| 55700-508 | Finasteride | finasteride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |