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Generated: October 20, 2018

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 Pharms Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. 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. Eighteen suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.
Summary for 021287
Tradename:UROXATRAL
Applicant:Concordia Pharms Inc
Ingredient:alfuzosin hydrochloride
Patents:1
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 59212-200-20 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59212-200-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jun 12, 2003TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 22, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021287

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Concordia Pharms Inc UROXATRAL alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021287-001 Jun 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Concordia Pharms Inc UROXATRAL alfuzosin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021287-001 Jun 12, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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