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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 065190

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NDA 065190 describes CEFUROXIME AXETIL, which is a drug marketed by Sun Pharm Inds Ltd, Alkem Labs Ltd, Anda Repository, Ani Pharms, Apotex, Aurobindo Pharma, Chartwell Rx, Fosun Pharma, Lupin, and Ranbaxy Labs Ltd, and is included in eleven NDAs. It is available from seventeen suppliers. Additional details are available on the CEFUROXIME AXETIL profile page.

The generic ingredient in CEFUROXIME AXETIL is cefuroxime axetil. There are sixty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

Summary for 065190

Tradename:	CEFUROXIME AXETIL
Applicant:	Ani Pharms
Ingredient:	cefuroxime axetil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Oct 18, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Oct 18, 2004	TE:		RLD:	No

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