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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 202824


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NDA 202824 describes DOXAZOSIN MESYLATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Ani Pharms, Apotex, Aurobindo Pharma Usa, Chartwell Rx, Genpharm, Heritage Pharma, Ivax Sub Teva Pharms, Nesher Pharms, Pliva, Rising, Strides Pharma, Teva, Unichem, Upsher Smith Labs, Watson Labs Inc, and Zydus Pharms, and is included in nineteen NDAs. It is available from twenty-nine suppliers. Additional details are available on the DOXAZOSIN MESYLATE profile page.

The generic ingredient in DOXAZOSIN MESYLATE 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 202824
Tradename:DOXAZOSIN MESYLATE
Applicant:Accord Hlthcare
Ingredient:doxazosin mesylate
Patents:0
Pharmacology for NDA: 202824
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 202824
Suppliers and Packaging for NDA: 202824
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 202824 ANDA Accord Healthcare Inc. 16729-211 16729-211-01 100 TABLET in 1 BOTTLE (16729-211-01)
DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 202824 ANDA Accord Healthcare Inc. 16729-211 16729-211-17 1000 TABLET in 1 BOTTLE (16729-211-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No

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