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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Covington
Colorcon
McKinsey
Dow
Farmers Insurance
Express Scripts
Queensland Health
Johnson and Johnson

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203026

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NDA 203026 describes VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, and Watson Labs Teva, and is included in eight NDAs. Additional details are available on the VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in VALSARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 203026
Tradename:VALSARTAN AND HYDROCHLOROTHIAZIDE
Applicant:Apotex Inc
Ingredient:hydrochlorothiazide; valsartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203026
Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Mar 21, 2013TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Mar 21, 2013TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG;320MG
Approval Date:Mar 21, 2013TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Harvard Business School
Boehringer Ingelheim
Moodys
US Army
Citi
Mallinckrodt
Johnson and Johnson
McKesson

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