BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
Fuji
Daiichi Sankyo
Mallinckrodt
Healthtrust
Dow
Argus Health
Accenture
Novartis

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202696

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NDA 202696 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 202696
Tradename:VALSARTAN
Applicant:Macleods Pharms Ltd
Ingredient:valsartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202696
Medical Subject Heading (MeSH) Categories for 202696
Suppliers and Packaging for NDA: 202696
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN valsartan TABLET;ORAL 202696 ANDA Macleods Pharmaceuticals Limited 33342-062 33342-062-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-062-07)
VALSARTAN valsartan TABLET;ORAL 202696 ANDA Macleods Pharmaceuticals Limited 33342-062 33342-062-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-062-44)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Sep 16, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Sep 16, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Sep 16, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
Medtronic
Colorcon
Baxter
Teva
Dow
Federal Trade Commission
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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