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Details for New Drug Application (NDA): 203081

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NDA 203081 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-four NDAs. It is available from twenty-six 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. There are four tentative approvals for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for NDA: 203081

Tradename:
IRBESARTAN
Applicant:
Aurobindo Pharma Ltd
Ingredient:
irbesartan
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203081

Suppliers and Packaging for NDA: 203081

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN
irbesartan
TABLET;ORAL 203081 ANDA Aurobindo Pharma Limited 65862-637 65862-637-05 500 TABLET in 1 BOTTLE (65862-637-05)
IRBESARTAN
irbesartan
TABLET;ORAL 203081 ANDA Aurobindo Pharma Limited 65862-637 65862-637-30 30 TABLET in 1 BOTTLE (65862-637-30)

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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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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