Details for New Drug Application (NDA): 064125

NDA 064125 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 is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.

Summary for 064125

Tradename:	CEFUROXIME SODIUM
Applicant:	Acs Dobfar Spa
Ingredient:	cefuroxime sodium
Patents:	0

Pharmacology for NDA: 064125

Suppliers and Packaging for NDA: 064125

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	064125	ANDA	Sagent Pharmaceuticals	25021-118	25021-118-10	25 VIAL in 1 CARTON (25021-118-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
CEFUROXIME SODIUM	cefuroxime sodium	INJECTABLE;INJECTION	064125	ANDA	Sagent Pharmaceuticals	25021-119	25021-119-20	25 VIAL in 1 CARTON (25021-119-20) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 750MG BASE/VIAL
Approval Date:	May 30, 1997	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:	May 30, 1997	TE:	AP	RLD:	No

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