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Serving hundreds of leading biopharmaceutical companies globally:

Teva
QuintilesIMS
Queensland Health
Accenture
Chinese Patent Office
Cipla
Boehringer Ingelheim
Express Scripts
Merck

Generated: May 27, 2018

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 thirteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 079106
Tradename:BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Applicant:Unichem
Ingredient:bisoprolol fumarate; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079106
Ingredient-typeThiazides
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 Blenheim Pharmacal, Inc. 10544-173 E 10544-173-30
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate; hydrochlorothiazide TABLET;ORAL 079106 ANDA Blenheim Pharmacal, Inc. 10544-174 E 10544-174-90

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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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
McKinsey
Chubb
Covington
Mallinckrodt
Teva
Cerilliant
Moodys
McKesson

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