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Details for New Drug Application (NDA): 090720

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NDA 090720 describes IRBESARTAN, which is a drug marketed by Roxane, Cipla Ltd, Hetero Labs Ltd V, Zydus Pharms Usa Inc, Unichem Labs Ltd, Watson Labs Inc, Lupin Ltd, Apotex Inc, Jubilant Generics, Alembic Pharms Ltd, Macleods Pharms Ltd, Teva Pharms, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz, Prinston Inc, Sciegen Pharms Inc, Aurobindo Pharma Ltd, Ajanta Pharma Ltd, Hisun Pharm Hangzhou, Intl Speclt Chems, and Teva, and is included in thirty-three NDAs. It is available from twenty-five 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. Seventeen suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for NDA: 090720

Watson Labs Inc
Therapeutic Class:Cardiovascular Agents

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Oct 12, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 12, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 12, 2012TE:ABRLD:No

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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.