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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204821

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NDA 204821 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. Thirty suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 204821
Tradename:VALSARTAN
Applicant:Prinston Inc
Ingredient:valsartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204821
Medical Subject Heading (MeSH) Categories for 204821
Suppliers and Packaging for NDA: 204821
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 204821 ANDA Solco Healthcare US, LLC 43547-367 43547-367-11 1000 TABLET in 1 BOTTLE (43547-367-11)
VALSARTAN valsartan TABLET;ORAL 204821 ANDA Solco Healthcare US, LLC 43547-367 43547-367-03 30 TABLET in 1 BOTTLE (43547-367-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jun 9, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jun 9, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jun 9, 2015TE:ABRLD:No

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