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ACTIVE SUBSTANCE / INN

RILUZOLE

Brand name(s): Riluzole Zentiva, RILUTEK, EXSERVAN, TIGLUTIK KIT, Rilutek, RILUZOLE
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA020599
NDA209080
ACTIVE SUBSTANCE
Riluzole
REGULATORS
FDA · EMA
SPONSORS / MAH
COVIS, Sanofi Winthrop Industrie, SUN PHARM INDS LTD
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RILUZOLEANDA091394GLENMARK PHARMS LTDPrescription
RILUZOLEANDA091417SUN PHARM INDS LTDDiscontinued
EXSERVANNDA212640AQUESTIVEDiscontinued
RILUTEKNDA020599COVISDiscontinued
TIGLUTIK KITNDA209080ITALFARMACO SAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Riluzole ZentivaZentiva k.s.Authorised07/05/2012Amyotrophic Lateral Sclerosis
RilutekSanofi Winthrop IndustrieAuthorised10/06/1996Amyotrophic Lateral Sclerosis

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