ACTIVE SUBSTANCE / INN

SAFINAMIDE

Brand name(s): Xadago, SAFINAMIDE
FDA LISTED
EMA LISTED
AUTHORISED
NONE (TENTATIVE APPROVAL)
Parkinson Disease
ANDA215945
ACTIVE SUBSTANCE
Safinamide
REGULATORS
FDA · EMA
SPONSORS / MAH
RK PHARMA, Zambon SpA
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SAFINAMIDEANDA215945RK PHARMANone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
XadagoZambon SpAAuthorised23/02/2015Parkinson Disease

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