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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Healthtrust
Cantor Fitzgerald
Argus Health
US Department of Justice
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US Army
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Generated: January 18, 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. It is available from twenty-three suppliers. Additional details are available on the VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in VALSARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Thirty suppliers are listed 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
Suppliers and Packaging for NDA: 203026
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 203026 ANDA Apotex Corp. 60505-3806 60505-3806-5 500 TABLET, FILM COATED in 1 BOTTLE (60505-3806-5)
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 203026 ANDA Apotex Corp. 60505-3806 60505-3806-9 90 TABLET, FILM COATED in 1 BOTTLE (60505-3806-9)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cipla
Healthtrust
Accenture
Fish and Richardson
Citi
Cerilliant
Queensland Health
Dow

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