Last Updated: September 24, 2026

Details for New Drug Application (NDA): 062807

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NDA 062807 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 Antibiotics, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, and Hq Spclt Pharma, and is included in thirty-four NDAs. It is available from sixteen suppliers. Additional details are available on the CEFAZOLIN SODIUM profile page.

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

Summary for 062807

Tradename:	CEFAZOLIN SODIUM
Applicant:	Hikma
Ingredient:	cefazolin sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 062807

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 250MG BASE/VIAL
Approval Date:	Jan 12, 1988	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jan 12, 1988	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Jan 12, 1988	TE:		RLD:	No

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