Details for New Drug Application (NDA): 079013

NDA 079013 describes ALFUZOSIN HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Norvium Bioscience, Sun Pharm, Torrent Pharms, Unichem, and Wockhardt, and is included in nine NDAs. It is available from eleven 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. Twelve suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.

Summary for 079013

Tradename:	ALFUZOSIN HYDROCHLORIDE
Applicant:	Apotex Inc
Ingredient:	alfuzosin hydrochloride
Patents:	0

Pharmacology for NDA: 079013

Mechanism of Action

Adrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 079013

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079013	ANDA	Golden State Medical Supply, Inc.	51407-829	51407-829-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-829-90)
ALFUZOSIN HYDROCHLORIDE	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079013	ANDA	Apotex Corp.	60505-2850	60505-2850-9	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-2850-9)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Jul 18, 2011	TE:	AB	RLD:	No

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