Application 204304
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
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 |
|---|---|---|---|---|---|
| 50090-4697 | Finasteride | Finasteride | A-S Medication Solutions | ANDA | Current |
| 50090-4697 | Finasteride | Finasteride | A-S Medication Solutions | ANDA | Current |
| 67877-288 | Finasteride | Finasteride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-288 | Finasteride | Finasteride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-288 | Finasteride | Finasteride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-288 | Finasteride | Finasteride | Ascend Laboratories, LLC | ANDA | Current |
| 71335-1898 | Finasteride | Finasteride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1898 | Finasteride | Finasteride | Bryant Ranch Prepack | ANDA | Current |
| 71610-520 | Finasteride | Finasteride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-520 | Finasteride | Finasteride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 46839 | ORIG | 2017-01-13 |