Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 16, 2019

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, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Square Pharms Ltd, Torrent, Unichem Labs Ltd, Watson Labs Inc, Apotex Inc, Mylan Pharms Inc, Watson Labs Teva, and Zydus Pharms, and is included in twenty-five NDAs. It is available from twenty-seven 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. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 077492
Tradename:VALSARTAN
Applicant:Ohm Labs Inc
Ingredient:valsartan
Patents:0
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 43353-203-79 2160 TABLET, FILM COATED in 1 BOTTLE (43353-203-79)
VALSARTAN valsartan TABLET;ORAL 077492 ANDA Northwind Pharmaceuticals, LLC 51655-652 51655-652-52 30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (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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