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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 065496

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NDA 065496 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 065496

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

Pharmacology for NDA: 065496

Suppliers and Packaging for NDA: 065496

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065496	ANDA	Major Pharmaceuticals	0904-7542	0904-7542-10	2 BLISTER PACK in 1 CARTON (0904-7542-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065496	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-656	43063-656-14	14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-656-14)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 250MG BASE
Approval Date:	Jun 7, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 500MG BASE
Approval Date:	Jun 7, 2010	TE:	AB	RLD:	No

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