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Fish and Richardson
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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090866

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NDA 090866 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 090866
Tradename:VALSARTAN
Applicant:Mylan Pharms Inc
Ingredient:valsartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090866
Medical Subject Heading (MeSH) Categories for 090866
Suppliers and Packaging for NDA: 090866
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 090866 ANDA Mylan Pharmaceuticals Inc. 0378-5807 N 0378-5807-93
VALSARTAN valsartan TABLET;ORAL 090866 ANDA Mylan Pharmaceuticals Inc. 0378-5813 N 0378-5813-77

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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