Last Updated: November 8, 2026

Details for New Drug Application (NDA): 065516

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NDA 065516 describes CEFOTAXIME SODIUM, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira, Hospira Inc, Lupin, and Wockhardt, and is included in nine NDAs. Additional details are available on the CEFOTAXIME SODIUM profile page.

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

Summary for 065516

Tradename:	CEFOTAXIME SODIUM
Applicant:	Aurobindo Pharma Ltd
Ingredient:	cefotaxime sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 065516

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Nov 6, 2009	TE:		RLD:	No

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