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Details for New Drug Application (NDA): 090221

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NDA 090221 describes ALFUZOSIN HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Mylan, Wockhardt Ltd, Torrent Pharms, Teva Pharms, Sun Pharma Global, Aurobindo Pharma Ltd, Invagen Pharms, and Unichem Labs Ltd, and is included in nine NDAs. It is available from eighteen 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-two suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.

Summary for NDA: 090221

Wockhardt Ltd
alfuzosin hydrochloride
Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 090221

Mechanism of ActionAdrenergic alpha-Antagonists

Suppliers and Packaging for NDA: 090221

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
alfuzosin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 090221 ANDA Wockhardt Limited 55648-738 55648-738-01 30 TABLET in 1 BOTTLE (55648-738-01)
alfuzosin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 090221 ANDA Wockhardt Limited 55648-738 55648-738-02 100 TABLET in 1 BOTTLE (55648-738-02)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Aug 10, 2012TE:RLD:No

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