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ACTIVE SUBSTANCE / INN

TERIFLUNOMIDE

Brand name(s): TERIFLUNOMIDE, Teriflunomide Accord, Aubagio, Teriflunomide Viatris (previously Teriflunomide Mylan), AUBAGIO
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA209668
ANDA209549
ACTIVE SUBSTANCE
Teriflunomide
REGULATORS
FDA · EMA
SPONSORS / MAH
WATSON LABS TEVA, ZYDUS PHARMS, Viatris Limited
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TERIFLUNOMIDEANDA209668ZYDUS PHARMSPrescription
TERIFLUNOMIDEANDA209549WATSON LABS TEVADiscontinued
AUBAGIONDA202992SANOFI AVENTIS USPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Teriflunomide AccordAccord Healthcare S.L.U.Authorised09/11/2022Multiple Sclerosis, Relapsing-Remitting
Teriflunomide Viatris (previously Teriflunomide Mylan)Viatris LimitedAuthorised09/11/2022Multiple Sclerosis, Relapsing-Remitting
AubagioSanofi Winthrop IndustrieAuthorised26/08/2013Multiple Sclerosis

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