Application 212452
- Type
- ANDA
- Sponsor
- EYWA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | URSODIOL | URSODIOL | CAPSULE;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63629-1173 | Ursodiol | Ursodiol | Bryant Ranch Prepack | ANDA | Current |
| 63629-1173 | Ursodiol | Ursodiol | Bryant Ranch Prepack | ANDA | Current |
| 71930-015 | Ursodiol | Ursodiol | Eywa Pharma Inc | ANDA | Current |
| 72789-205 | Ursodiol | Ursodiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-205 | Ursodiol | Ursodiol | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |