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ACTIVE SUBSTANCE / INN

DRONEDARONE

Brand name(s): DRONEDARONE, Multaq
FDA LISTED
EMA LISTED
APPLICATION WITHDRAWN
AUTHORISED
NONE (TENTATIVE APPROVAL)
ANDA206649
Atrial Fibrillation
ACTIVE SUBSTANCE
Dronedarone
REGULATORS
FDA · EMA
SPONSORS / MAH
Sanofi Winthrop Industrie, Sanofi-Aventis, AMNEAL PHARMS
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DRONEDARONEANDA206649AMNEAL PHARMSNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
MultaqSanofi Winthrop IndustrieAuthorised25/11/2009Atrial Fibrillation
MultaqSanofi-AventisApplication withdrawnAtrial Fibrillation;Atrial Flutter

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