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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 202254


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NDA 202254 describes IRBESARTAN, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem, Upsher Smith Labs, Watson Labs Inc, Zydus Pharms Usa Inc, Alembic, Atlas Pharms Llc, Dr Reddys Labs Ltd, Mylan Pharms Inc, and Teva, and is included in thirty-six NDAs. It is available from nineteen suppliers. Additional details are available on the IRBESARTAN profile page.

The generic ingredient in IRBESARTAN is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.
Summary for 202254
Tradename:IRBESARTAN
Applicant:Macleods Pharms Ltd
Ingredient:irbesartan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202254
Suppliers and Packaging for NDA: 202254
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRBESARTAN irbesartan TABLET;ORAL 202254 ANDA Macleods Pharmaceuticals Limited 33342-047 33342-047-07 30 TABLET in 1 BOTTLE (33342-047-07)
IRBESARTAN irbesartan TABLET;ORAL 202254 ANDA Macleods Pharmaceuticals Limited 33342-047 33342-047-10 90 TABLET in 1 BOTTLE (33342-047-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength75MG
Approval Date:Oct 3, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 3, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 3, 2012TE:ABRLD:No

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