Application 204262
- Type
- ANDA
- Sponsor
- STRIDES PHARMA
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 |
|---|---|---|---|---|---|
| 64380-763 | Dutasteride | Dutasteride | Strides Pharma Science Limited | ANDA | Current |
| 64380-763 | Dutasteride | Dutasteride | Strides Pharma Science Limited | ANDA | Current |
| 64380-763 | Dutasteride | Dutasteride | Strides Shasun Limited | ANDA | Current |
| 64380-763 | Dutasteride | Dutasteride | Strides Pharma Science Limited | ANDA | Current |
| 64380-763 | Dutasteride | Dutasteride | Strides Pharma Science Limited | ANDA | Current |
| 70518-2256 | Dutasteride | Dutasteride | REMEDYREPACK INC. | ANDA | Current |