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Serving leading biopharmaceutical companies globally:

Teva
Federal Trade Commission
US Department of Justice
Julphar
Merck
Covington
Baxter
Johnson and Johnson
Colorcon
Chubb

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203685

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NDA 203685 describes IRBESARTAN, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cipla Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem Labs Ltd, Watson Labs Inc, West-ward Pharms Int, Zydus Pharms Usa Inc, Atlas Pharms Llc, and Teva, and is included in thirty-five NDAs. It is available from twenty-four suppliers. Additional details are available on the IRBESARTAN profile page.

The generic ingredient in IRBESARTAN is hydrochlorothiazide; irbesartan. There are thirty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for 203685
Tradename:IRBESARTAN
Applicant:Ajanta Pharma Ltd
Ingredient:irbesartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203685
Suppliers and Packaging for NDA: 203685
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN irbesartan TABLET;ORAL 203685 ANDA Ajanta Pharma Limited 27241-033 27241-033-03 30 TABLET in 1 BOTTLE (27241-033-03)
IRBESARTAN irbesartan TABLET;ORAL 203685 ANDA Ajanta Pharma Limited 27241-033 27241-033-09 90 TABLET in 1 BOTTLE (27241-033-09)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength75MG
Approval Date:Dec 10, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength150MG
Approval Date:Dec 10, 2015TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG
Approval Date:Dec 10, 2015TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Novartis
Merck
Baxter
Farmers Insurance
Julphar
Johnson and Johnson
AstraZeneca
Daiichi Sankyo
Fuji

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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