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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021287

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NDA 021287 describes UROXATRAL, which is a drug marketed by Concordia and is included in one NDA. It is available from one supplier. Additional details are available on the UROXATRAL profile page.

The generic ingredient in UROXATRAL is alfuzosin hydrochloride. There are nineteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.
Summary for 021287
Tradename:UROXATRAL
Applicant:Concordia
Ingredient:alfuzosin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021287
Mechanism of ActionAdrenergic alpha-Antagonists
Suppliers and Packaging for NDA: 021287
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UROXATRAL alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021287 NDA Concordia Pharmaceuticals Inc. 59212-200 59212-200-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-10)
UROXATRAL alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021287 NDA Concordia Pharmaceuticals Inc. 59212-200 59212-200-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-30)
Paragraph IV (Patent) Challenges for 021287
Tradename Dosage Ingredient NDA Submissiondate
UROXATRAL TABLET, EXTENDED RELEASE;ORAL alfuzosin hydrochloride 021287 2007-06-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jun 12, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021287

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Concordia UROXATRAL alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021287-001 Jun 12, 2003   Start Trial   Start Trial
Concordia UROXATRAL alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021287-001 Jun 12, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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