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Last Updated: January 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079106

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NDA 079106 describes BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Actavis Elizabeth, Apothecon, Ivax Sub Teva Pharms, Mylan, Sandoz, Teva, Unichem, and Watson Labs Teva, and is included in nine NDAs. It is available from six 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. Eight suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 079106
Pharmacology for NDA: 079106
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 079106
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 079106 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-187 29300-187-01 100 TABLET in 1 BOTTLE, PLASTIC (29300-187-01)
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 079106 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-187 29300-187-05 500 TABLET in 1 BOTTLE, PLASTIC (29300-187-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;6.25MG
Approval Date:Jul 28, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;6.25MG
Approval Date:Jul 28, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;6.25MG
Approval Date:Jul 28, 2010TE:ABRLD:No

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