vorapaxar Oral Tablet

Brand(s)
Zontivity
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-04-16)
Oldest Current Product
2014-05-08
License(s)
NDA
RxNORM
ORAL TABLET\VORAPAXAR
FDAOB
ORAL\TABLET\VORAPAXAR SULFATE
SPL Active
ORAL\TABLET, FILM COATED\VORAPAXAR SULFATE
SPL Moiety
ORAL\TABLET, FILM COATED\VORAPAXAR

product(s) by strength(s)

vorapaxar 2.08 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060351ZontivityNDAMerck Sharp & Dohme Corp.2014-05-08VORAPAXAR SULFATEORALTABLET, FILM COATEDNDA20488645d79217-53cf-4240-9c43-19ee54a1dc3a

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204886ZONTIVITYMERCK SHARP AND DOHME CORP2014-05-08p7304078, REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS, SUBSTANCE
p7235567, SUBSTANCE
NEW CHEMICAL ENTITY [2019-05-08]NDA204886_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204886_001RXVORAPAXAR SULFATE (EQ 2.08MG BASE)ORALTABLETTrue2014-05-08ZONTIVITY

patent(s)

#idexpiration dateapplication(s)
1p7235567 (view patent)2021-06-13NDA204886
2p7304078 (view patent)2024-04-06NDA204886

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
145d79217-53cf-4240-9c43-19ee54a1dc3a (view SPL)These highlights do not include all the information needed to use ZONTIVITY safely and effectively. See full prescribing information for ZONTIVITY.ZONTIVITY (vorapaxar) Tablets 2.08 mg*, for oral use*Equivalent to 2.5 mg vorapaxar sulfateInitial U.S. Approval: 2014prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.2015-04-164000060351

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