Application 065261
- Type
- ANDA
- Sponsor
- LUPIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFPROZIL | CEFPROZIL | FOR SUSPENSION;ORAL | 125MG/5ML | No | No |
| 002 | CEFPROZIL | CEFPROZIL | FOR SUSPENSION;ORAL | 250MG/5ML | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57297-401 | CEFPROZIL | CEFPROZIL | LUPIN LIMITED | ANDA | Current |
| 57297-402 | CEFPROZIL | CEFPROZIL | LUPIN LIMITED | ANDA | Current |
| 68180-401 | CEFPROZIL | CEFPROZIL | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-401 | CEFPROZIL | CEFPROZIL | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-401 | CEFPROZIL | CEFPROZIL | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-402 | CEFPROZIL | CEFPROZIL | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-402 | CEFPROZIL | CEFPROZIL | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-402 | CEFPROZIL | CEFPROZIL | Lupin Pharmaceuticals, Inc. | ANDA | Current |