Details for New Drug Application (NDA): 021269

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NDA 021269 describes CARDURA XL, which is a drug marketed by Viatris and is included in one NDA. It is available from two suppliers. Additional details are available on the CARDURA XL profile page.

The generic ingredient in CARDURA XL is doxazosin mesylate. There are fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.

Summary for 021269

Tradename:	CARDURA XL
Applicant:	Viatris
Ingredient:	doxazosin mesylate
Patents:	0

Pharmacology for NDA: 021269

Mechanism of Action	Adrenergic alpha-Antagonists

Medical Subject Heading (MeSH) Categories for 021269

Adrenergic alpha-1 Receptor Antagonists
Antihypertensive Agents

Suppliers and Packaging for NDA: 021269

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269	NDA	Roerig	0049-2040	0049-2040-10	30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0049-2040-10)
CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269	NDA	Roerig	0049-2080	0049-2080-10	30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0049-2080-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Feb 22, 2005	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 8MG BASE
Approval Date:	Feb 22, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021269

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	CARDURA XL	doxazosin mesylate	TABLET, EXTENDED RELEASE;ORAL	021269-002	Feb 22, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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