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US Department of Justice
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202254

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NDA 202254 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-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for 202254
Tradename:IRBESARTAN
Applicant:Macleods Pharms Ltd
Ingredient:irbesartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202254
Suppliers and Packaging for NDA: 202254
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN irbesartan TABLET;ORAL 202254 ANDA Macleods Pharmaceuticals Limited 33342-047 N 33342-047-15
IRBESARTAN irbesartan TABLET;ORAL 202254 ANDA Macleods Pharmaceuticals Limited 33342-047 N 33342-047-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Oct 3, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 3, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 3, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
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Johnson and Johnson

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