Details for New Drug Application (NDA): 019668

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NDA 019668 describes CARDURA, which is a drug marketed by Viatris and is included in two NDAs. It is available from three suppliers. Additional details are available on the CARDURA profile page.

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

Summary for 019668

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

Pharmacology for NDA: 019668

Mechanism of Action	Adrenergic alpha-Antagonists

Medical Subject Heading (MeSH) Categories for 019668

Adrenergic alpha-1 Receptor Antagonists
Antihypertensive Agents

Suppliers and Packaging for NDA: 019668

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARDURA	doxazosin mesylate	TABLET;ORAL	019668	NDA	ROERIG	0049-2410	0049-2410-10	100 TABLET in 1 BOTTLE (0049-2410-10)
CARDURA	doxazosin mesylate	TABLET;ORAL	019668	NDA	ROERIG	0049-2512	0049-2512-10	100 TABLET in 1 BOTTLE (0049-2512-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 1MG BASE
Approval Date:	Nov 2, 1990	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE
Approval Date:	Nov 2, 1990	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Nov 2, 1990	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019668

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-004	Nov 2, 1990	⤷ Sign Up	⤷ Sign Up
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-001	Nov 2, 1990	⤷ Sign Up	⤷ Sign Up
Viatris	CARDURA	doxazosin mesylate	TABLET;ORAL	019668-003	Nov 2, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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