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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 065071

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NDA 065071 describes CEFOTAXIME, which is a drug marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira, Hospira Inc, and Lupin, and is included in fourteen NDAs. It is available from one supplier. Additional details are available on the CEFOTAXIME profile page.

The generic ingredient in CEFOTAXIME is cefotaxime sodium. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefotaxime sodium profile page.

Summary for 065071

Tradename:	CEFOTAXIME
Applicant:	Hikma
Ingredient:	cefotaxime sodium
Patents:	0

Pharmacology for NDA: 065071

Medical Subject Heading (MeSH) Categories for 065071

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 065071

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFOTAXIME	cefotaxime sodium	INJECTABLE;INJECTION	065071	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9935	0143-9935-01	1 INJECTION in 1 PACKAGE (0143-9935-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Nov 20, 2002	TE:		RLD:	No

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