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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 075384


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NDA 075384 describes TERAZOSIN HYDROCHLORIDE, which is a drug marketed by Apnar Pharma Lp, Bionpharma, Heritage Pharma Avet, Hikma, Jubilant Cadista, Norvium Bioscience, Ranbaxy Labs Ltd, Chartwell Rx, Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in twelve NDAs. It is available from twenty-one suppliers. Additional details are available on the TERAZOSIN HYDROCHLORIDE profile page.

The generic ingredient in TERAZOSIN HYDROCHLORIDE is terazosin hydrochloride. There are twenty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the terazosin hydrochloride profile page.
Summary for 075384
Tradename:TERAZOSIN HYDROCHLORIDE
Applicant:Norvium Bioscience
Ingredient:terazosin hydrochloride
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Dec 1, 2000TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Dec 1, 2000TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Dec 1, 2000TE:RLD:No

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