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ACTIVE SUBSTANCE / INN

DEXAMETHASONE

Brand name(s): DEXONE 0.75, DEXAMETHASONE, TOBRAMYCIN AND DEXAMETHASONE, CIPROFLOXACIN AND DEXAMETHASONE, Ozurdex, HEMADY, MAXIDEX, Neofordex, DEXACIDIN, HEXADROL, CIPRODEX
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
DISCONTINUED
NDA012674
Multiple Myeloma
ACTIVE SUBSTANCE
Dexamethasone
REGULATORS
FDA · EMA
SPONSORS / MAH
Laboratoires CTRS - Boulogne Billancourt, DR REDDYS, SANDOZ
TOTAL APPLICATIONS
13
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DEXAMETHASONEANDA084763SUN PHARM INDUSTRIESDiscontinued
DEXAMETHASONEANDA088248HIKMAPrescription
CIPRODEXNDA021537SANDOZPrescription
HEXADROLNDA012674ASPEN GLOBAL INCDiscontinued
MAXIDEXNDA013422HARROW EYEPrescription
TOBRAMYCIN AND DEXAMETHASONEANDA212715PADAGIS USPrescription
DEXACIDINANDA062544NOVARTISDiscontinued
DEXONE 0.75ANDA084993SOLVAYDiscontinued
CIPROFLOXACIN AND DEXAMETHASONEANDA205548DR REDDYSPrescription
HEMADYNDA211379DEXCELPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OzurdexAbbVie Deutschland GmbH & Co. KGAuthorised26/07/2010Macular Edema;Uveitis
NeofordexTHERAVIAAuthorised16/03/2016Multiple Myeloma
NeofordexLaboratoires CTRS - Boulogne BillancourtApplication withdrawnMultiple Myeloma

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