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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090201

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NDA 090201 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 090201
Tradename:IRBESARTAN
Applicant:West-ward Pharms Int
Ingredient:irbesartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090201
Suppliers and Packaging for NDA: 090201
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN irbesartan TABLET;ORAL 090201 ANDA West-Ward Pharmaceuticals Corp. 0054-0250 0054-0250-22 90 TABLET in 1 BOTTLE (0054-0250-22)
IRBESARTAN irbesartan TABLET;ORAL 090201 ANDA West-Ward Pharmaceuticals Corp. 0054-0250 0054-0250-13 30 TABLET in 1 BOTTLE (0054-0250-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Oct 15, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 15, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 15, 2012TE:ABRLD:No

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