Application 209909
- Type
- ANDA
- Sponsor
- HUMANWELL PURACAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DUTASTERIDE | DUTASTERIDE | CAPSULE;ORAL | 0.5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42806-549 | Dutasteride | Dutasteride | Epic Pharma, LLC | ANDA | Current |
| 42806-549 | Dutasteride | Dutasteride | Epic Pharma, LLC | ANDA | Current |
| 51013-190 | Dutasteride | Dutasteride | PuraCap Pharmaceutical LLC | ANDA | Current |
| 53345-037 | Dutasteride | Dutasteride | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | ANDA | Current |
| 68071-4609 | Dutasteride | Dutasteride | NuCare Pharmaceuticals,Inc. | ANDA | Current |