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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 065239

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NDA 065239 describes CEFOXITIN, which is a drug marketed by Acs Dobfar, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira Inc, B Braun, and Samson Medcl, and is included in fourteen NDAs. It is available from four suppliers. Additional details are available on the CEFOXITIN profile page.

The generic ingredient in CEFOXITIN is cefoxitin sodium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.

Summary for 065239

Tradename:	CEFOXITIN
Applicant:	Hikma Farmaceutica
Ingredient:	cefoxitin sodium
Patents:	0

Pharmacology for NDA: 065239

Medical Subject Heading (MeSH) Categories for 065239

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 065239

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065239	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9876	0143-9876-10	10 BOTTLE in 1 CARTON (0143-9876-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE (0143-9876-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Mar 2, 2010	TE:	AP	RLD:	No

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