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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 079060


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NDA 079060 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 079060
Tradename:ALFUZOSIN HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:alfuzosin hydrochloride
Patents:0
Pharmacology for NDA: 079060
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 079060
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079060 ANDA Northwind Pharmaceuticals, LLC 51655-087 51655-087-52 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-087-52)
ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079060 ANDA Rising Pharma Holdings, Inc. 57237-114 57237-114-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Aug 30, 2012TE:ABRLD:No

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