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Details for New Drug Application (NDA): 065048
The generic ingredient in CEFUROXIME SODIUM is cefuroxime sodium. There are sixty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
Summary for 065048
Tradename: | CEFUROXIME SODIUM |
Applicant: | Hikma Farmaceutica |
Ingredient: | cefuroxime sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065048
Ingredient-type | Cephalosporins |
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 | West-Ward Pharmaceutical Corp | 0143-9567 | N | 0143-9567-25 |
CEFUROXIME SODIUM | cefuroxime sodium | INJECTABLE;INJECTION | 065048 | ANDA | West-Ward Pharmaceutical Corp | 0143-9568 | N | 0143-9568-25 |
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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