FDA.reportPublic FDA data

Application 204384

Type
NDA
Sponsor
JANSSEN THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIRTUROBEDAQUILINE FUMARATETABLET;ORALEQ 100MG BASEYesYes
002SIRTUROBEDAQUILINE FUMARATETABLET;ORALEQ 20MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-701SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-702SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent
59676-702SIRTUROBedaquiline FumarateJanssen Products, LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82977SUPPL 2025-07-29
82969SUPPL 2025-07-29
82968SUPPL 2025-07-29
78880SUPPL 2024-06-24
78869SUPPL 2024-06-24
75728SUPPL 2023-10-13
75714SUPPL 2023-10-12
68833SUPPL2021-10-01
68832SUPPL2021-10-01
68788SUPPL2021-09-27
63332SUPPL2020-05-29
63310SUPPL2020-05-27
61529SUPPL2020-01-07
61527SUPPL2020-01-07
61526SUPPL2020-01-07
61155SUPPL2019-12-04
61154SUPPL2019-12-04
61143SUPPL2019-12-04
59730SUPPL2019-08-16
59680SUPPL2019-08-13
59658SUPPL2019-08-12
19553SUPPL2015-12-15
10335SUPPL2015-12-10
19552SUPPL2015-05-21
32548SUPPL2015-05-19
10334SUPPL2014-10-22
19551SUPPL2014-10-21
40382SUPPL2013-08-29
32547SUPPL2013-08-29
24468ORIG2013-02-13
22955ORIG2013-02-13
32546ORIG2013-01-02
40381ORIG2012-12-31