teriflunomide Oral Tablet

Brand(s)
Aubagio
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genzyme Corporation (2014-10-16)
Oldest Current Product
2013-05-01
License(s)
NDA
RxNORM
ORAL TABLET\TERIFLUNOMIDE
FDAOB
ORAL\TABLET\TERIFLUNOMIDE
SPL Active
ORAL\TABLET, FILM COATED\TERIFLUNOMIDE
SPL Moiety
ORAL\TABLET, FILM COATED\TERIFLUNOMIDE

product(s) by strength(s)

teriflunomide 14 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1584680210AubagioNDAGenzyme Corporation2013-05-012054-12-31TERIFLUNOMIDEORALTABLET, FILM COATEDNDA2029924650d12c-b9c8-4525-b07f-a2d773eca155

teriflunomide 7 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1584680211AubagioNDAGenzyme Corporation2013-05-012054-12-31TERIFLUNOMIDEORALTABLET, FILM COATEDNDA2029924650d12c-b9c8-4525-b07f-a2d773eca155

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202992AUBAGIOSANOFI AVENTIS US LLC2012-09-12p5679709, TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS, SUBSTANCE
p6794410, TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
p8802735, SUBSTANCE
NEW CHEMICAL ENTITY [2017-09-12]NDA202992_001, NDA202992_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202992_001RXTERIFLUNOMIDE (7MG)ORALTABLETFalse2012-09-12AUBAGIO
2NDA202992_002RXTERIFLUNOMIDE (14MG)ORALTABLETTrue2012-09-12AUBAGIO

patent(s)

#idexpiration dateapplication(s)
1p5679709 (view patent)2014-10-21NDA202992
2p6794410 (view patent)2022-04-15NDA202992
3p8802735 (view patent)2030-09-14NDA202992

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14650d12c-b9c8-4525-b07f-a2d773eca155 (view SPL)These highlights do not include all the information needed to use AUBAGIO safely and effectively. See full prescribing information for AUBAGIO. AUBAGIO (teriflunomide) tablets, for oral use Initial U.S. Approval: 2012prescriptionHuman PrescriptionGenzyme CorporationANALYSIS, LABEL, MANUFACTURE, PACK2014-10-165584680210, 584680211

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII