Application 203687
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA 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 |
|---|
| 35573-400 | Finasteride | Finasteride | Burel Pharmaceuticals, LLC | ANDA | Current |
| 35573-400 | Finasteride | Finasteride | Burel Pharma | ANDA | Current |
| 35573-400 | Finasteride | Finasteride | Burel Pharmaceuticals, Inc. | ANDA | Current |
| 35573-400 | Finasteride | Finasteride | Burel Pharma | ANDA | Current |
| 35573-400 | Finasteride | Finasteride | Burel Pharmaceuticals, LLC | ANDA | Current |
| 50436-0927 | Finasteride | Finasteride | Unit Dose Services | ANDA | Current |
| 57237-061 | Finasteride | Finasteride | Rising Health, LLC | ANDA | Current |
| 57237-061 | Finasteride | Finasteride | Rising Health, LLC | ANDA | Current |
| 57237-061 | Finasteride | Finasteride | Rising Health, LLC | ANDA | Current |
| 57237-061 | Finasteride | Finasteride | Rising Health, LLC | ANDA | Current |
| 65862-927 | Finasteride | Finasteride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-927 | Finasteride | Finasteride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-927 | Finasteride | Finasteride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-927 | Finasteride | Finasteride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-927 | Finasteride | Finasteride | Aurobindo Pharma Limited | ANDA | Current |
| 68071-4808 | Finasteride | Finasteride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4808 | Finasteride | Finasteride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6875 | Finasteride | Finasteride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6875 | Finasteride | Finasteride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6875 | Finasteride | Finasteride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6875 | Finasteride | Finasteride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6875 | Finasteride | Finasteride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71335-0281 | Finasteride | Finasteride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0281 | Finasteride | Finasteride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0281 | Finasteride | Finasteride | Bryant Ranch Prepack | ANDA | Current |
| 76420-151 | Finasteride | Finasteride | Asclemed USA, Inc. | ANDA | Current |
| 76420-153 | Finasteride | Finasteride | Asclemed USA, Inc. | ANDA | Current |