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. Eleven 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

Pharmacology for NDA: 021287

Mechanism of Action	Adrenergic 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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	Jun 12, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021287

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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	4,661,491*PED	⤷ Subscribe
Concordia	UROXATRAL	alfuzosin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021287-001	Jun 12, 2003	6,149,940*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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