Application 077021
- Type
- ANDA
- Sponsor
- CASI PHARMS INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CILOSTAZOL | CILOSTAZOL | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0185-0223 | Cilostazol | Cilostazol | Eon Labs, Inc. | ANDA | Current |
| 68071-2065 | Cilostazol | Cilostazol | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71610-037 | Cilostazol | Cilostazol | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|---|---|---|---|---|
| 8992 | 0 | ORIG | 1 | 2004-12-02 | FDA source fallback |