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ACTIVE SUBSTANCE / INN

ENTACAPONE

Brand name(s): Comtan, CARBIDOPA, LEVODOPA AND ENTACAPONE, Comtess, STALEVO 200, COMTAN, STALEVO 100, STALEVO 150, Entacapone Orion, STALEVO 50, ENTACAPONE, STALEVO 75, STALEVO 125, Entacapone Teva
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA020796
Parkinson Disease
ACTIVE SUBSTANCE
Entacapone
REGULATORS
FDA · EMA
SPONSORS / MAH
Teva Pharma B.V., Orion Corporation, SUN PHARM
TOTAL APPLICATIONS
14
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CARBIDOPA, LEVODOPA AND ENTACAPONEANDA079085SUN PHARMDiscontinued
ENTACAPONEANDA090690SUN PHARMPrescription
CARBIDOPA, LEVODOPA AND ENTACAPONEANDA214495MACLEODS PHARMS LTDPrescription
COMTANNDA020796ORION PHARMAPrescription
STALEVO 75NDA021485ORION PHARMAPrescription
STALEVO 150NDA021485ORION PHARMAPrescription
STALEVO 50NDA021485ORION PHARMAPrescription
STALEVO 125NDA021485ORION PHARMAPrescription
STALEVO 200NDA021485ORION PHARMAPrescription
STALEVO 100NDA021485ORION PHARMAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Entacapone OrionOrion CorporationAuthorised18/08/2011Parkinson Disease
ComtessOrion CorporationAuthorised16/09/1998Parkinson Disease
ComtanOrion CorporationAuthorised22/09/1998Parkinson Disease
Entacapone TevaTeva Pharma B.V.Authorised18/02/2011Parkinson Disease

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