Details for New Drug Application (NDA): 065303

NDA 065303 describes CEFAZOLIN SODIUM, which is a drug marketed by Abraxis Pharm, Acs Dobfar, Aurobindo Pharma, Bedford, Cephazone Pharma, Dr Reddys, Facta Farma, Fresenius Kabi Usa, Glaxosmithkline, Hikma, Hikma Farmaceutica, Hospira, Hospira Inc, Qilu, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, and Hq Spclt Pharma, and is included in thirty-four NDAs. It is available from nineteen suppliers. Additional details are available on the CEFAZOLIN SODIUM profile page.

The generic ingredient in CEFAZOLIN SODIUM is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.

Summary for 065303

Tradename:	CEFAZOLIN SODIUM
Applicant:	Acs Dobfar
Ingredient:	cefazolin sodium
Patents:	0

Pharmacology for NDA: 065303

Medical Subject Heading (MeSH) Categories for 065303

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 065303

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	065303	ANDA	Sagent Pharmaceuticals	25021-100	25021-100-10	25 VIAL in 1 CARTON (25021-100-10) / 2.2 mL in 1 VIAL
CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	065303	ANDA	Sagent Pharmaceuticals	25021-101	25021-101-10	25 VIAL in 1 CARTON (25021-101-10) / 3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Oct 22, 2008	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Oct 22, 2008	TE:	AP	RLD:	No

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