Application 091031
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFOTETAN | CEFOTETAN DISODIUM | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
| 002 | CEFOTETAN | CEFOTETAN DISODIUM | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0143-9670 | Cefotetan | Cefotetan | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9670 | Cefotetan | Cefotetan | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9671 | Cefotetan | Cefotetan | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9671 | Cefotetan | Cefotetan | West-Ward Pharmaceuticals Corp | ANDA | Current |