FDA
NDA 020757 (label) INN (IRBESARTAN) AVAPRO (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1997
NDA 020758 (label) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) AVALIDE (SANOFI AVENTIS US) APPROVAL= AP YEAR= 1997
NDA 090815 (pdf not found) INN (IRBESARTAN ; HYDROCHLOROTHIAZIDE) IRBESARTAN; HYDROCHLOROTHIAZIDE (ZYDUS PHARMS USA INC) APPROVAL= TA YEAR= 2011
NDA 077159 (pdf not found) INN (IRBESARTAN) IRBESARTAN (TEVA PHARMS) APPROVAL= AP YEAR= 2012
NDA 077369 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (TEVA) APPROVAL= AP YEAR= 2012
NDA 077446 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (SANDOZ) APPROVAL= AP YEAR= 2012
NDA 077466 (pdf not found) INN (IRBESARTAN) IRBESARTAN (SANDOZ) APPROVAL= AP YEAR= 2012
NDA 077969 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (MYLAN PHARMS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 077205 (pdf not found) INN (IRBESARTAN) IRBESARTAN (CHARTWELL MOLECULAR) APPROVAL= AP YEAR= 2012
NDA 091236 (pdf not found) INN (IRBESARTAN) IRBESARTAN (ALEMBIC PHARMS LTD) APPROVAL= AP YEAR= 2012
NDA 079213 (pdf not found) INN (IRBESARTAN) IRBESARTAN (ZYDUS PHARMS USA INC) APPROVAL= AP YEAR= 2012
NDA 090351 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (HIKMA) APPROVAL= AP YEAR= 2012
NDA 202414 (pdf not found) INN (IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012
NDA 200461 (pdf not found) INN (IRBESARTAN) IRBESARTAN (APPCO) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 201531 (pdf not found) INN (IRBESARTAN) IRBESARTAN (LUPIN LTD) APPROVAL= AP YEAR= 2012
NDA 202254 (pdf not found) INN (IRBESARTAN) IRBESARTAN (MACLEODS PHARMS LTD) APPROVAL= AP YEAR= 2012
NDA 091370 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (ALEMBIC) APPROVAL= AP YEAR= 2012
NDA 200832 (pdf not found) INN (IRBESARTAN) IRBESARTAN (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 090201 (pdf not found) INN (IRBESARTAN) IRBESARTAN (HIKMA) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 090720 (pdf not found) INN (IRBESARTAN) IRBESARTAN (WATSON LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 091539 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (WATSON LABS INC) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 201505 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (APOTEX INC) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 201616 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) HYDROCHLOROTHIAZIDE; IRBESARTAN (CIPLA LIMITED) APPROVAL= TA YEAR= 2012
NDA 202910 (pdf not found) INN (IRBESARTAN) IRBESARTAN (HETERO LABS LTD V) APPROVAL= AP YEAR= 2012
NDA 203071 (pdf not found) INN (IRBESARTAN) IRBESARTAN (PRINSTON INC) APPROVAL= AP YEAR= 2012
NDA 203081 (pdf not found) INN (IRBESARTAN) IRBESARTAN (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2012
NDA 203161 (pdf not found) INN (IRBESARTAN) IRBESARTAN (CHARTWELL RX) APPROVAL= AP YEAR= 2012 DISCONTINUED
NDA 203500 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (DR REDDYS LABS LTD) APPROVAL= AP YEAR= 2012
NDA 201524 (pdf not found) INN (IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (LUPIN LTD) APPROVAL= AP YEAR= 2013
NDA 203630 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (AUROBINDO PHARMA LTD) APPROVAL= AP YEAR= 2013
NDA 203072 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (PRINSTON INC) APPROVAL= AP YEAR= 2014
NDA 203020 (pdf not found) INN (IRBESARTAN) IRBESARTAN (UNICHEM) APPROVAL= AP YEAR= 2015
NDA 203534 (pdf not found) INN (IRBESARTAN) IRBESARTAN (JUBILANT GENERICS) APPROVAL= AP YEAR= 2015
NDA 203685 (pdf not found) INN (IRBESARTAN) IRBESARTAN (AJANTA PHARMA LTD) APPROVAL= AP YEAR= 2015 DISCONTINUED
NDA 204774 (pdf not found) INN (IRBESARTAN) IRBESARTAN (SCIEGEN PHARMS INC) APPROVAL= AP YEAR= 2015
NDA 203036 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (ATLAS PHARMS LLC) APPROVAL= AP YEAR= 2016 DISCONTINUED
NDA 206194 (pdf not found) INN (IRBESARTAN) IRBESARTAN (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2016
NDA 207896 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (HISUN PHARM HANGZHOU) APPROVAL= AP YEAR= 2016
NDA 207018 (pdf not found) INN (HYDROCHLOROTHIAZIDE ; IRBESARTAN) IRBESARTAN AND HYDROCHLOROTHIAZIDE (UNICHEM) APPROVAL= AP YEAR= 2017 DISCONTINUED
NDA 204740 (pdf not found) INN (IRBESARTAN) IRBESARTAN (AMNEAL PHARMS) APPROVAL= AP YEAR= 2018
NDA 211056 (pdf not found) INN (IRBESARTAN) IRBESARTAN (IPCA LABS LTD) APPROVAL= AP YEAR= 2024 DISCONTINUED