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ACTIVE SUBSTANCE / INN

IRBESARTAN

Brand name(s): HYDROCHLOROTHIAZIDE; IRBESARTAN, IRBESARTAN HYDROCHLOROTHIAZIDE, IRBESARTAN; HYDROCHLOROTHIAZIDE, Sabervel, Karvea, Ifirmasta (previously Irbesartan Krka), Irbesartan BMS, Aprovel, Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), IRBESARTAN AND HYDROCHLOROTHIAZIDE, AVALIDE, IRBESARTAN
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
EXPIRED
ANDA201524
NDA020758
ACTIVE SUBSTANCE
Irbesartan
REGULATORS
FDA · EMA
SPONSORS / MAH
HISUN PHARM HANGZHOU, LUPIN LTD, Pharmathen S.A.
TOTAL APPLICATIONS
17
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
IRBESARTAN AND HYDROCHLOROTHIAZIDEANDA201505APOTEX INCDiscontinued
IRBESARTAN HYDROCHLOROTHIAZIDEANDA201505APOTEX INCNone (Tentative Approval)
HYDROCHLOROTHIAZIDE; IRBESARTANANDA201616CIPLA LIMITEDNone (Tentative Approval)
IRBESARTANANDA206194HISUN PHARM HANGZHOUPrescription
IRBESARTAN AND HYDROCHLOROTHIAZIDEANDA207896HISUN PHARM HANGZHOUPrescription
IRBESARTANANDA090201HIKMADiscontinued
IRBESARTAN; HYDROCHLOROTHIAZIDEANDA201524LUPIN LTDNone (Tentative Approval)
IRBESARTAN AND HYDROCHLOROTHIAZIDEANDA203072PRINSTON INCNone (Tentative Approval)
AVALIDENDA020758SANOFI AVENTIS USDiscontinued
AVALIDENDA020758SANOFI AVENTIS USPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AprovelSanofi Winthrop IndustrieAuthorised26/08/1997Hypertension
KarveaSanofi Winthrop IndustrieAuthorised26/08/1997Hypertension
Ifirmasta (previously Irbesartan Krka)Krka, d.d., Novo mestoAuthorised01/12/2008Hypertension
Irbesartan Zentiva (previously Irbesartan Winthrop)Zentiva k.s.Authorised19/01/2007Hypertension
Irbesartan TevaTeva B.V.Authorised30/10/2009Hypertension
SabervelPharmathen S.A.Expired13/04/2012Hypertension
Irbesartan BMSBristol-Myers Squibb Pharma EEIGWithdrawn19/01/2007Hypertension

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