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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 205210


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NDA 205210 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-eight 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-one suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.
Summary for 205210
Tradename:DOXAZOSIN MESYLATE
Applicant:Heritage Pharma
Ingredient:doxazosin mesylate
Patents:0
Pharmacology for NDA: 205210
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 205210
Suppliers and Packaging for NDA: 205210
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 205210 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-092 23155-092-01 100 TABLET in 1 BOTTLE (23155-092-01)
DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 205210 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-093 23155-093-01 100 TABLET in 1 BOTTLE (23155-093-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Feb 13, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Feb 13, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Feb 13, 2018TE:ABRLD:No

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