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Generated: November 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079054

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NDA 079054 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 seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.
Summary for 079054
Tradename:ALFUZOSIN HYDROCHLORIDE
Applicant:Torrent Pharms
Ingredient:alfuzosin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079054
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 079054
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079054 ANDA Torrent Pharmaceuticals Limited 13668-021 13668-021-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-021-01)
ALFUZOSIN HYDROCHLORIDE alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 079054 ANDA Torrent Pharmaceuticals Limited 13668-021 13668-021-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-021-05)

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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