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US Department of Justice

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021269

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

The generic ingredient in CARDURA XL is doxazosin mesylate. There are thirteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.
Summary for 021269
Tradename:CARDURA XL
Applicant:Pfizer
Ingredient:doxazosin mesylate
Patents:0
Therapeutic Class:Cardiovascular Agents
Genitourinary Agents
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 0049-2710 N 0049-2710-30
CARDURA XL doxazosin mesylate TABLET, EXTENDED RELEASE;ORAL 021269 NDA Roerig 0049-2720 N 0049-2720-30

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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