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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206194

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NDA 206194 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 206194

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

Pharmacology for NDA: 206194

Suppliers and Packaging for NDA: 206194

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN irbesartan TABLET;ORAL 206194 ANDA Hisun Pharmaceuticals USA Inc. 42658-121 42658-121-01 30 TABLET, FILM COATED in 1 BOTTLE (42658-121-01)
IRBESARTAN irbesartan TABLET;ORAL 206194 ANDA Hisun Pharmaceuticals USA Inc. 42658-121 42658-121-04 90 TABLET, FILM COATED in 1 BOTTLE (42658-121-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Jun 14, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jun 14, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jun 14, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Healthtrust
Mallinckrodt
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Argus Health
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Merck
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Dow
Cantor Fitzgerald
Novartis

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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