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Last Updated: March 29, 2024

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. Twenty-eight 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021269
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 021269
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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 4MG BASE
Approval Date:Feb 22, 2005TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 8MG BASE
Approval Date:Feb 22, 2005TE:RLD:Yes

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