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ACTIVE SUBSTANCE / INN

CLADRIBINE

Brand name(s): Litak, LEUSTATIN, MAVENCLAD, CLADRIBINE, Movectro, Mavenclad
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
DISCONTINUED
NDA020229
ANDA200510
ACTIVE SUBSTANCE
Cladribine
REGULATORS
FDA · EMA
SPONSORS / MAH
PHARMOBEDIENT, EMD SERONO INC, FRESENIUS KABI USA
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CLADRIBINEANDA076571FRESENIUS KABI USAPrescription
LEUSTATINNDA020229JANSSEN PHARMSDiscontinued
MAVENCLADNDA022561EMD SERONO INCPrescription
CLADRIBINEANDA200510PHARMOBEDIENTDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
MavencladMerck Europe B.V.Authorised22/08/2017Multiple Sclerosis
LitakLipomed GmbHAuthorised14/04/2004Leukemia, Hairy Cell
MovectroMerck Serono Europe LimitedApplication withdrawnMultiple Sclerosis

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