Application 207750
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FINASTERIDE | FINASTERIDE | TABLET;ORAL | 1MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4648 | Finasteride | Finasteride | A-S Medication Solutions | ANDA | Current |
| 50436-0455 | Finasteride | Finasteride | Unit Dose Services | ANDA | Current |
| 67877-455 | Finasteride | Finasteride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-455 | Finasteride | Finasteride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-455 | Finasteride | Finasteride | Ascend Laboratories, LLC | ANDA | Current |
| 68071-2620 | Finasteride | Finasteride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-8275 | Finasteride | Finasteride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2287 | Finasteride | Finasteride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2287 | Finasteride | Finasteride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2287 | Finasteride | Finasteride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2287 | Finasteride | Finasteride | REMEDYREPACK INC. | ANDA | Current |
| 71335-1304 | Finasteride | Finasteride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1304 | Finasteride | Finasteride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1304 | Finasteride | Finasteride | Bryant Ranch Prepack | ANDA | Current |
| 71713-099 | Finasteride | Finasteride | Thirty Madison Inc | ANDA | Current |