Application 204292
- Type
- ANDA
- Sponsor
- APOTEX INC
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 |
|---|---|---|---|---|---|
| 50090-2285 | Dutasteride | dutasteride | A-S Medication Solutions | ANDA | Current |
| 60429-935 | Dutasteride | dutasteride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-935 | Dutasteride | dutasteride | Golden State Medical Supply | ANDA | Current |
| 60505-3877 | Dutasteride | dutasteride | Apotex Corp. | ANDA | Current |
| 60505-3877 | Dutasteride | dutasteride | Apotex Corp. | ANDA | Current |
| 68071-4237 | Dutasteride | dutasteride | NuCare Pharmaceuticals,Inc. | ANDA | Current |