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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075642


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NDA 075642 describes BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Actavis Elizabeth, Apothecon, Cadila, Chartwell Rx, Edenbridge Pharms, Epic Pharma Llc, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Novitium Pharma, Teva, Unichem, and Watson Labs Teva, and is included in thirteen NDAs. It is available from ten suppliers. Additional details are available on the BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 075642
Tradename:BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Applicant:Apothecon
Ingredient:bisoprolol fumarate; hydrochlorothiazide
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG;6.25MG
Approval Date:Dec 27, 2000TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG;6.25MG
Approval Date:Dec 27, 2000TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;6.25MG
Approval Date:Dec 27, 2000TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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