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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090642

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NDA 090642 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, Watson Labs Inc, Apotex Inc, and Watson Labs Teva, and is included in twenty-two NDAs. It is available from twenty-nine 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-three suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 090642
Tradename:VALSARTAN
Applicant:Watson Labs Inc
Ingredient:valsartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090642
Medical Subject Heading (MeSH) Categories for 090642
Suppliers and Packaging for NDA: 090642
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 090642 ANDA Actavis Pharma, Inc. 0591-2167 N 0591-2167-19
VALSARTAN valsartan TABLET;ORAL 090642 ANDA Actavis Pharma, Inc. 0591-2167 N 0591-2167-30

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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Harvard Business School
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