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ACTIVE SUBSTANCE / INN

LEFLUNOMIDE

Brand name(s): LEFLUNOMIDE, Arava, ARAVA, Leflunomide Teva, Leflunomide Zentiva (previously Leflunomide Winthrop), Leflunomide ratiopharm, Repso, Leflunomide medac
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
ANDA077086
Arthritis, Rheumatoid
ACTIVE SUBSTANCE
Leflunomide
REGULATORS
FDA · EMA
SPONSORS / MAH
HERITAGE, Teva B.V., SANDOZ
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
LEFLUNOMIDEANDA077085SANDOZDiscontinued
LEFLUNOMIDEANDA077086HERITAGEPrescription
ARAVANDA020905SANOFI AVENTIS USPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Leflunomide Zentiva (previously Leflunomide Winthrop)Zentiva k.s.Authorised08/01/2010Arthritis, Rheumatoid;Arthritis, Psoriatic
Leflunomide medacmedac Gesellschaft für klinische Spezialpräparate mbHAuthorised27/07/2010Arthritis, Rheumatoid
Leflunomide ratiopharmRatiopharm GmbHAuthorised28/11/2010Arthritis, Rheumatoid
AravaSanofi-aventis Deutschland GmbHAuthorised02/09/1999Arthritis, Rheumatoid;Arthritis, Psoriatic
RepsoTeva B.V.Withdrawn14/03/2011Arthritis, Rheumatoid;Arthritis, Psoriatic
Leflunomide TevaTeva Pharma B.V.Lapsed10/03/2011Arthritis, Rheumatoid

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