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ACTIVE SUBSTANCE / INN

FLUOCINOLONE ACETONIDE

Brand name(s): FLAC, Retisert, SYNALAR, FLUOCET, SYNALAR-HP, ILUVIEN, TRI-LUMA, FLUOCINONIDE ACETONIDE, FLUOCINOLONE ACETONIDE, FLUONID
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
DISCONTINUED
ANDA211815
ANDA210736
ACTIVE SUBSTANCE
Fluocinolone Acetonide
REGULATORS
FDA · EMA
SPONSORS / MAH
ALLIED, FOUGERA PHARMS INC, Bausch Lomb Ireland
TOTAL APPLICATIONS
11
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FLUONIDANDA087158ALLERGAN HERBERTDiscontinued
FLUOCINOLONE ACETONIDEANDA088047ALLIEDDiscontinued
FLUOCINOLONE ACETONIDEANDA088169FOUGERA PHARMS INCPrescription
FLUOCETANDA088360ALPHARMA US PHARMSDiscontinued
ILUVIENNDA201923ALIMERA SCIENCES INCPrescription
FLACANDA210736ANDA REPOSITORYPrescription
SYNALAR-HPNDA016161EUROFARMADiscontinued
FLUOCINONIDE ACETONIDEANDA211815GLENMARK PHARMS LTDDiscontinued
TRI-LUMANDA021112GALDERMA LABS LPPrescription
SYNALARNDA013960EUROFARMAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RetisertBausch Lomb IrelandApplication withdrawn—

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