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Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079013

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NDA 079013 describes ALFUZOSIN HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Invagen Pharms, Mylan, Sun Pharma Global, Teva Pharms, Torrent Pharms, Unichem Labs Ltd, and Wockhardt Ltd, and is included in nine NDAs. It is available from nineteen 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. Twenty suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.
Summary for 079013
Applicant:Apotex Inc
Ingredient:alfuzosin hydrochloride
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 079013
Mechanism of ActionAdrenergic 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 AvKARE, Inc. 42291-110 N 42291-110-10
ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079013 ANDA AvKARE, Inc. 42291-110 N 42291-110-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jul 18, 2011TE:ABRLD:No

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