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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204774

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NDA 204774 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 204774

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

Pharmacology for NDA: 204774

Suppliers and Packaging for NDA: 204774

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN irbesartan TABLET;ORAL 204774 ANDA Camber Pharmaceuticals, Inc. 31722-160 31722-160-05 500 TABLET in 1 BOTTLE (31722-160-05)
IRBESARTAN irbesartan TABLET;ORAL 204774 ANDA Camber Pharmaceuticals, Inc. 31722-161 31722-161-10 1000 TABLET in 1 BOTTLE (31722-161-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Dec 7, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 7, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Dec 7, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Novartis
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Julphar
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Fuji
Medtronic
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Teva

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