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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Queensland Health

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202223

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NDA 202223 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 202223
Applicant:Aurobindo Pharma Ltd
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202223
Medical Subject Heading (MeSH) Categories for 202223
Suppliers and Packaging for NDA: 202223
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 202223 ANDA LUCID PHARMA LLC 52343-122 N 52343-122-30
VALSARTAN valsartan TABLET;ORAL 202223 ANDA LUCID PHARMA LLC 52343-123 N 52343-123-90

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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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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Fish and Richardson

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