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ACTIVE SUBSTANCE / INN

MIDOSTAURIN

Brand name(s): Rydapt, RYDAPT, MIDOSTAURIN
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA215834
NDA207997
ACTIVE SUBSTANCE
Midostaurin
REGULATORS
FDA · EMA
SPONSORS / MAH
TEVA PHARMS, LOTUS PHARM CO LTD, Novartis Europharm Ltd
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
MIDOSTAURINANDA216015LUPINPrescription
RYDAPTNDA207997NOVARTISPrescription
MIDOSTAURINANDA215834LOTUS PHARM CO LTDNone (Tentative Approval)
MIDOSTAURINANDA216076TEVA PHARMSDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RydaptNovartis Europharm LtdAuthorised18/09/2017Leukemia, Myeloid, Acute;Mastocytosis

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