Details for New Drug Application (NDA): 065048
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NDA 065048 describes CEFUROXIME SODIUM, which is a drug marketed by Acs Dobfar Spa, Fresenius Kabi Usa, Hikma, Hospira Inc, Teva Pharms, Watson Labs Inc, and Samson Medcl, and is included in fourteen NDAs. It is available from two suppliers. Additional details are available on the CEFUROXIME SODIUM profile page.
The generic ingredient in CEFUROXIME SODIUM is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
The generic ingredient in CEFUROXIME SODIUM is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
Summary for 065048
| Tradename: | CEFUROXIME SODIUM |
| Applicant: | Hikma |
| Ingredient: | cefuroxime sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065048
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME SODIUM | cefuroxime sodium | INJECTABLE;INJECTION | 065048 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9567 | 0143-9567-25 | 25 VIAL in 1 CARTON (0143-9567-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9567-01) |
| CEFUROXIME SODIUM | cefuroxime sodium | INJECTABLE;INJECTION | 065048 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9568 | 0143-9568-25 | 25 VIAL in 1 CARTON (0143-9568-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9568-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 750MG BASE/VIAL | ||||
| Approval Date: | Jan 9, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.5GM BASE/VIAL | ||||
| Approval Date: | Jan 9, 2004 | TE: | AP | RLD: | No | ||||
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