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Serving leading biopharmaceutical companies globally:

Chubb
Fish and Richardson
Harvard Business School
Citi
Mallinckrodt
Teva
Queensland Health
Healthtrust
Daiichi Sankyo
Dow

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203071

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NDA 203071 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-one 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. Eighteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for 203071

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203071

Suppliers and Packaging for NDA: 203071

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN irbesartan TABLET;ORAL 203071 ANDA Solco healthcare U.S., LLC 43547-277 43547-277-50 500 TABLET in 1 BOTTLE (43547-277-50)
IRBESARTAN irbesartan TABLET;ORAL 203071 ANDA Solco healthcare U.S., LLC 43547-277 43547-277-03 30 TABLET in 1 BOTTLE (43547-277-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Sep 27, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Sep 27, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Federal Trade Commission
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Merck
Dow
Cantor Fitzgerald
Chinese Patent Office
Fuji

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