Application 065048
- Type
- ANDA
- Sponsor
- HIKMA FARMACEUTICA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | EQ 750MG BASE/VIAL | No | No |
| 002 | CEFUROXIME SODIUM | CEFUROXIME SODIUM | INJECTABLE;INJECTION | EQ 1.5GM BASE/VIAL | No | No |
| 003 | CEFUROXIME | CEFUROXIME | Injectable; Injection | 1.5G/20ML | No | No |
| 004 | CEFUROXIME | CEFUROXIME | Injectable; Injection | 1.5G/100ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0143-9567 | Cefuroxime | Cefuroxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9567 | Cefuroxime | Cefuroxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9568 | Cefuroxime | Cefuroxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9568 | Cefuroxime | Cefuroxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9977 | Cefuroxime | Cefuroxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9977 | Cefuroxime | Cefuroxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9977 | Cefuroxime | Cefuroxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9979 | Cefuroxime | Cefuroxime | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9979 | Cefuroxime | Cefuroxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9979 | Cefuroxime | Cefuroxime | Hikma Pharmaceuticals USA Inc. | ANDA | Current |