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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Accenture
Medtronic
Healthtrust
Cantor Fitzgerald
Deloitte
Queensland Health
Boehringer Ingelheim
Cerilliant
Citi

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206083

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NDA 206083 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-four 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-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 206083
Tradename:VALSARTAN AND HYDROCHLOROTHIAZIDE
Applicant:Prinston Inc
Ingredient:hydrochlorothiazide; valsartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206083
Ingredient-typeThiazides
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 206083
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 206083 ANDA Solco Healthcare US, LLC 43547-311 43547-311-50 500 TABLET, FILM COATED in 1 BOTTLE (43547-311-50)
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 206083 ANDA Solco Healthcare US, LLC 43547-311 43547-311-03 30 TABLET, FILM COATED in 1 BOTTLE (43547-311-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Feb 8, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Feb 8, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;320MG
Approval Date:Feb 8, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Medtronic
Merck
Julphar
US Department of Justice
McKinsey
Daiichi Sankyo
Queensland Health
Fuji

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