Application 201890
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET;ORAL | 10MG;10MG | No | No |
| 002 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET;ORAL | 10MG;20MG | No | No |
| 003 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET;ORAL | 10MG;40MG | No | No |
| 004 | EZETIMIBE AND SIMVASTATIN | EZETIMIBE; SIMVASTATIN | TABLET;ORAL | 10MG;80MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1385 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN | Impax Generics | ANDA | Current |
| 0115-1386 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN | Impax Generics | ANDA | Current |
| 0115-1387 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN | Impax Generics | ANDA | Current |
| 0115-1388 | Ezetimibe and Simvastatin | EZETIMIBE and SIMVASTATIN | Impax Generics | ANDA | Current |