Application 065235
- Type
- ANDA
- Sponsor
- CASI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFPROZIL | CEFPROZIL | TABLET;ORAL | 250MG | No | No |
| 002 | CEFPROZIL | CEFPROZIL | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-5043 | Cefprozil | Cefprozil | Sandoz Inc | ANDA | Current |
| 0781-5044 | Cefprozil | Cefprozil | Sandoz Inc | ANDA | Current |
| 55700-455 | Cefprozil | Cefprozil | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-455 | Cefprozil | Cefprozil | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 67253-231 | Cefprozil | Cefprozil | DAVA Pharmaceuticals Inc | ANDA | Current |
| 67253-232 | Cefprozil | Cefprozil | DAVA Pharmaceuticals Inc | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30656 | ORIG | 2005-11-18 |