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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076161

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NDA 076161 describes DOXAZOSIN MESYLATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Apotex, Dava Pharms Inc, Genpharm, Heritage Pharma, Idt Australia Ltd, Ivax Sub Teva Pharms, Mylan, Nesher Pharms, Pliva, Teva, Watson Labs Inc, Yaopharma Co Ltd, and Zydus Pharms Usa Inc, and is included in sixteen NDAs. It is available from thirty-two suppliers. Additional details are available on the DOXAZOSIN MESYLATE profile page.

The generic ingredient in DOXAZOSIN MESYLATE 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 076161
Applicant:Dava Pharms Inc
Ingredient:doxazosin mesylate
Therapeutic Class:Cardiovascular Agents
Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076161
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 076161
Suppliers and Packaging for NDA: 076161
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 076161 ANDA Major Pharmaceuticals 0904-6140 E 0904-6140-60
DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 076161 ANDA Major Pharmaceuticals 0904-6140 E 0904-6140-80

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Jun 10, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Jun 10, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jun 10, 2004TE:ABRLD:No

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