Application 077030
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CILOSTAZOL | CILOSTAZOL | TABLET;ORAL | 50MG | No | No |
| 002 | CILOSTAZOL | CILOSTAZOL | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-453 | cilostazol | cilostazol | AvKARE | ANDA | Current |
| 50268-176 | cilostazol | cilostazol | AvPAK | ANDA | Current |
| 50268-176 | cilostazol | cilostazol | AvPAK | ANDA | Current |
| 50268-177 | cilostazol | cilostazol | AvPAK | ANDA | Current |
| 50268-177 | cilostazol | cilostazol | AvPAK | ANDA | Current |
| 55154-6671 | cilostazol | cilostazol | Cardinal Health | ANDA | Current |
| 60505-2521 | cilostazol | cilostazol | Apotex Corp. | ANDA | Current |
| 60505-2522 | cilostazol | cilostazol | Apotex Corp. | ANDA | Current |
| 68788-9380 | cilostazol | cilostazol | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2714 | cilostazol | cilostazol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2714 | cilostazol | cilostazol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2714 | cilostazol | cilostazol | REMEDYREPACK INC. | ANDA | Current |
| 70518-2714 | cilostazol | cilostazol | REMEDYREPACK INC. | ANDA | Current |