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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075536


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NDA 075536 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-five 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the doxazosin mesylate profile page.
Summary for 075536
Tradename:DOXAZOSIN MESYLATE
Applicant:Teva
Ingredient:doxazosin mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075536
Mechanism of ActionAdrenergic alpha-Antagonists
Medical Subject Heading (MeSH) Categories for 075536
Suppliers and Packaging for NDA: 075536
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 075536 ANDA Teva Pharmaceuticals USA, Inc. 0093-2067 0093-2067-01 100 TABLET in 1 BOTTLE (0093-2067-01)
DOXAZOSIN MESYLATE doxazosin mesylate TABLET;ORAL 075536 ANDA Teva Pharmaceuticals USA, Inc. 0093-2068 0093-2068-01 100 TABLET in 1 BOTTLE (0093-2068-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Oct 18, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Oct 18, 2000TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Oct 18, 2000TE:ABRLD:No

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