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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Chubb
Farmers Insurance
Harvard Business School
US Department of Justice
Fuji
AstraZeneca
Fish and Richardson
Moodys

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203311

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NDA 203311 describes VALSARTAN, which is a drug marketed by Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Ohm Labs Inc, Prinston Inc, Square Pharms Ltd, Torrent Pharms Ltd, Unichem Labs Ltd, Watson Labs Inc, Apotex Inc, and Watson Labs Teva, and is included in twenty-three NDAs. It is available from thirty-one suppliers. Additional details are available on the VALSARTAN profile page.

The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 203311
Tradename:VALSARTAN
Applicant:Hetero Labs Ltd V
Ingredient:valsartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203311
Medical Subject Heading (MeSH) Categories for 203311
Suppliers and Packaging for NDA: 203311
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 203311 ANDA Camber Pharmaceuticals, Inc. 31722-745 N 31722-745-05
VALSARTAN valsartan TABLET;ORAL 203311 ANDA Camber Pharmaceuticals, Inc. 31722-745 N 31722-745-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jan 5, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jan 5, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jan 5, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
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Merck
Healthtrust
Deloitte
US Department of Justice
Johnson and Johnson
Mallinckrodt
Cipla

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