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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 24, 2018

DrugPatentWatch Database Preview

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 Farmaceutica, 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-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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Serving hundreds of leading biopharmaceutical companies globally:

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