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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 065043

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NDA 065043 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 fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

Summary for 065043

Tradename:	CEFUROXIME AXETIL
Applicant:	Ranbaxy Labs Ltd
Ingredient:	cefuroxime axetil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Feb 15, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Feb 15, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 125MG BASE
Approval Date:	Feb 15, 2002	TE:		RLD:	No

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