Application 090061
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0179-0175 | Finasteride | Finasteride | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0904-6830 | Finasteride | Finasteride | Major Pharmaceuticals | ANDA | Current |
| 0904-6830 | Finasteride | Finasteride | Major Pharmaceuticals | ANDA | Current |
| 0904-6830 | Finasteride | Finasteride | Major Pharmaceuticals | ANDA | Current |
| 0904-6830 | Finasteride | Finasteride | Major Pharmaceuticals | ANDA | Current |
| 31722-525 | Finasteride | Finasteride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 33261-833 | Finasteride | Finasteride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 43598-303 | Finasteride | Finasteride | Dr Reddys Laboratories Inc | ANDA | Current |
| 43598-303 | Finasteride | Finasteride | Dr Reddys Laboratories Inc | ANDA | Current |
| 50090-1936 | Finasteride | Finasteride | A-S Medication Solutions | ANDA | Current |
| 50090-1936 | Finasteride | Finasteride | A-S Medication Solutions | ANDA | Current |
| 50090-1936 | Finasteride | Finasteride | A-S Medication Solutions | ANDA | Current |
| 50268-314 | Finasteride | Finasteride | AvPAK | ANDA | Current |
| 50268-314 | Finasteride | Finasteride | AvPAK | ANDA | Current |
| 50268-314 | Finasteride | Finasteride | AvPAK | ANDA | Current |
| 50268-314 | Finasteride | Finasteride | AvPAK | ANDA | Current |
| 55154-8083 | Finasteride | Finasteride | Cardinal Health | ANDA | Current |
| 55154-8083 | Finasteride | Finasteride | Cardinal Health | ANDA | Current |
| 55154-8083 | Finasteride | Finasteride | Cardinal Health | ANDA | Current |
| 65977-5025 | Finasteride | Finasteride | Hetero Drugs Limited | ANDA | Current |
| 68071-2695 | Finasteride | Finasteride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68554-3025 | Finasteride | Finasteride | Hetero Labs Limited | ANDA | Current |
| 68645-541 | Finasteride | Finasteride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-541 | Finasteride | Finasteride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-541 | Finasteride | Finasteride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68645-541 | Finasteride | Finasteride | Legacy Pharmaceutical Packaging, LLC | ANDA | Current |
| 68788-9519 | Finasteride | Finasteride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9519 | Finasteride | Finasteride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-3182 | Finasteride | Finasteride | REMEDYREPACK INC. | ANDA | Current |
| 71610-515 | Finasteride | Finasteride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76282-412 | Finasteride | Finasteride | Exelan Pharmaceuticals Inc. | ANDA | Current |
| 76282-412 | Finasteride | Finasteride | Exelan Pharmaceuticals Inc. | ANDA | Current |