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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 065197

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NDA 065197 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 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 065197

Tradename:	CEFOTAXIME SODIUM
Applicant:	Wockhardt
Ingredient:	cefotaxime sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 065197

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Aug 29, 2006	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jun 20, 2008	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL
Approval Date:	Jun 20, 2008	TE:		RLD:	No

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