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ACTIVE SUBSTANCE / INN

ROMIDEPSIN

Brand name(s): Istodax, ISTODAX, ROMIDEPSIN
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
REFUSED
NDA208574
ANDA206254
ACTIVE SUBSTANCE
Romidepsin
REGULATORS
FDA · EMA
SPONSORS / MAH
Celgene Europe Ltd., BRISTOL-MYERS, TEVA PHARMS USA INC
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ROMIDEPSINANDA206254FRESENIUS KABI USAPrescription
ISTODAXNDA022393BRISTOL-MYERSPrescription
ROMIDEPSINNDA208574TEVA PHARMS USA INCDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
IstodaxCelgene Europe Ltd.RefusedLymphoma, Non-Hodgkin

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