Last Updated: September 24, 2026

Details for New Drug Application (NDA): 065001

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NDA 065001 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 065001

Tradename:	CEFUROXIME SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	cefuroxime sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 750MG BASE/VIAL
Approval Date:	May 30, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1.5GM BASE/VIAL
Approval Date:	May 30, 2001	TE:		RLD:	No

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