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ACTIVE SUBSTANCE / INN

TELMISARTAN

Brand name(s): Telmisartan Actavis, TELMISARTAN, Tolura, TELMISARTAN AND HYDROCHLOROTHIAZIDE, MICARDIS HCT, WIDAPLIK, Telmisartan Teva, TWYNSTA, Telmisartan Teva Pharma, TELMISARTAN AND AMLODIPINE, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), TELMISARTAN; HYDROCHLOROTHIAZIDE, Pritor, Micardis
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
ANDA206511
Hypertension
ACTIVE SUBSTANCE
Telmisartan
REGULATORS
FDA · EMA
SPONSORS / MAH
LUPIN LTD, AZURITY, BOEHRINGER INGELHEIM
TOTAL APPLICATIONS
17
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TELMISARTANANDA206511AUROBINDO PHARMAPrescription
TELMISARTAN AND HYDROCHLOROTHIAZIDEANDA091351LUPIN LTDPrescription
TELMISARTAN AND HYDROCHLOROTHIAZIDEANDA091648NATCODiscontinued
TELMISARTANANDA205901HETERO LABS LTD VDiscontinued
WIDAPLIKNDA219423AZURITYDiscontinued
MICARDIS HCTNDA021162BOEHRINGER INGELHEIMPrescription
TELMISARTAN AND AMLODIPINEANDA201586LUPIN LTDDiscontinued
TWYNSTANDA022401BOEHRINGER INGELHEIMDiscontinued
TELMISARTAN; HYDROCHLOROTHIAZIDEANDA091084WATSON LABS FLORIDANone (Tentative Approval)
TELMISARTAN AND AMLODIPINEANDA202516MYLANPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
MicardisBoehringer Ingelheim International GmbHAuthorised16/12/1998Hypertension
ToluraKrka, d.d., Novo mesto Authorised04/06/2010Hypertension
Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)Bayer AGAuthorised16/12/1998Hypertension
PritorBayer AGAuthorised11/12/1998Hypertension
Telmisartan ActavisActavis Group PTC ehfAuthorised29/09/2010Hypertension
Telmisartan Teva PharmaTeva B.V.Authorised03/10/2011Hypertension
Telmisartan TevaTeva B.V.Withdrawn25/01/2010Hypertension

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