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ACTIVE SUBSTANCE / INN

BUSULFAN

Brand name(s): Busilvex, BUSULFAN, MYLERAN, BUSULFEX, Busulfan Fresenius Kabi
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
NDA020954
ANDA215235
ACTIVE SUBSTANCE
Busulfan
REGULATORS
FDA · EMA
SPONSORS / MAH
OTSUKA PHARM, WAYLIS THERAP, Fresenius Kabi Deutschland GmbH
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BUSULFANANDA210448APOTEXDiscontinued
BUSULFANANDA215235PRINSTON INCPrescription
BUSULFEXNDA020954OTSUKA PHARMPrescription
MYLERANNDA009386WAYLIS THERAPPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Busulfan Fresenius KabiFresenius Kabi Deutschland GmbHAuthorised22/09/2014Hematopoietic Stem Cell Transplantation
BusilvexPierre Fabre MedicamentWithdrawn09/07/2003Hematopoietic Stem Cell Transplantation

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