rifapentine Oral Tablet

Brand(s)
Priftin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2014-12-30)
Oldest Current Product
1998-06-22
License(s)
NDA
RxNORM
ORAL TABLET\RIFAPENTINE
FDAOB
ORAL\TABLET\RIFAPENTINE
SPL Active
ORAL\TABLET, FILM COATED\RIFAPENTINE
SPL Moiety
ORAL\TABLET, FILM COATED\RIFAPENTINE

product(s) by strength(s)

rifapentine 150 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000882100PriftinNDASanofi-Aventis U.S. Llc1998-06-22RIFAPENTINEORALTABLET, FILM COATEDNDA021024f768e337-a948-420a-9fbe-9be359c7a170

application(s)

#idtitleapplicantapprovedapproved drug
1NDA021024PRIFTINSANOFI AVENTIS US LLC1998-06-22NDA021024_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021024_001RXRIFAPENTINE (150MG)ORALTABLETTrue1998-06-22PRIFTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f768e337-a948-420a-9fbe-9be359c7a170 (view SPL)These highlights do not include all the information needed to use PRIFTIN safely and effectively. See full prescribing information for PRIFTIN. Priftin (rifapentine) TabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-12-3015000882100

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