bedaquiline Oral Tablet

Brand(s)
Sirturo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Products, Lp (2015-10-07)
Oldest Current Product
2012-12-28
License(s)
NDA
RxNORM
ORAL TABLET\BEDAQUILINE
FDAOB
ORAL\TABLET\BEDAQUILINE FUMARATE
SPL Active
ORAL\TABLET\BEDAQUILINE FUMARATE
SPL Moiety
ORAL\TABLET\BEDAQUILINE

product(s) by strength(s)

bedaquiline 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596760701SirturoNDAJanssen Products, Lp2012-12-28BEDAQUILINE FUMARATEORALTABLETNDA2043841534c9ae-4948-4cf4-9f66-222a99db6d0e

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204384SIRTUROJANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP2012-12-28p7498343, TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS, SUBSTANCE
p8546428, TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2019-12-28]
NEW CHEMICAL ENTITY [2017-12-28]
NDA204384_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204384_001RXBEDAQUILINE FUMARATE (EQ 100MG BASE)ORALTABLETTrue2012-12-28SIRTURO

patent(s)

#idexpiration dateapplication(s)
1p7498343 (view patent)2024-10-02NDA204384
2p8546428 (view patent)2029-03-19NDA204384

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11534c9ae-4948-4cf4-9f66-222a99db6d0e (view SPL)These highlights do not include all the information needed to use SIRTURO safely and effectively. See full prescribing information for SIRTURO. SIRTURO (bedaquiline) tablets, for oral useInitial U.S. Approval 2012prescriptionHuman PrescriptionJanssen Products, LpANALYSIS, API MANUFACTURE, MANUFACTURE2015-10-078596760701

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