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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090221

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NDA 090221 describes ALFUZOSIN HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Pharmobedient, Sun Pharm, Torrent Pharms, Unichem, and Wockhardt Bio Ag, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the ALFUZOSIN HYDROCHLORIDE profile page.

The generic ingredient in ALFUZOSIN HYDROCHLORIDE is alfuzosin hydrochloride. There are nineteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.

Summary for 090221

Tradename:	ALFUZOSIN HYDROCHLORIDE
Applicant:	Wockhardt Bio Ag
Ingredient:	alfuzosin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Aug 10, 2012	TE:		RLD:	No

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