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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 five suppliers. 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. Twenty-three suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.

Summary for NDA: 021287

Tradename:
UROXATRAL
Applicant:
Concordia Pharms Inc
Ingredient:
alfuzosin hydrochloride
Patents:1
Therapeutic Class:Genitourinary Agents
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 sanofi-aventis U.S. LLC 0024-4200 0024-4200-10 1 BOTTLE in 1 CARTON (0024-4200-10) > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE
UROXATRAL
alfuzosin hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021287 NDA Stat Rx USA 16590-279 16590-279-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-279-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jun 12, 2003TE:ABRLD:Yes
Patent:6,149,940*PEDPatent Expiration:Feb 22, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book 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;ORAL021287-001Jun 12, 20034,661,491*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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