Application 065072
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFOTAXIME | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | Yes |
| 002 | CEFOTAXIME | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | Yes |
| 003 | CEFOTAXIME | CEFOTAXIME SODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9930 | Cefotaxime | Cefotaxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9930 | Cefotaxime | Cefotaxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9931 | Cefotaxime | Cefotaxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9931 | Cefotaxime | Cefotaxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9933 | Cefotaxime | Cefotaxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9933 | Cefotaxime | Cefotaxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22309 | ORIG | 2005-07-22 |