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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Boehringer Ingelheim
Chinese Patent Office

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077492

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NDA 077492 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, Torrent Pharms Ltd, Watson Labs Inc, Apotex Inc, and Watson Labs Teva, and is included in twenty-one NDAs. It is available from thirty suppliers. Additional details are available on the VALSARTAN profile page.

The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 077492
Applicant:Ohm Labs Inc
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077492
Medical Subject Heading (MeSH) Categories for 077492
Suppliers and Packaging for NDA: 077492
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 077492 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-203 N 43353-203-79
VALSARTAN valsartan TABLET;ORAL 077492 ANDA Northwind Pharmaceuticals, LLC 51655-652 N 51655-652-52

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jun 26, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jun 26, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jun 26, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health

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