FDA.reportPublic FDA data

Application 208434

Type
NDA
Sponsor
HOFFMANN-LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALECENSAALECTINIB HYDROCHLORIDECAPSULE;ORALEQ 150MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-130ALECENSAALECTINIB HYDROCHLORIDEGenentech, Inc.NDACurrent
50242-130ALECENSAALECTINIB HYDROCHLORIDEGenentech, Inc.NDACurrent
50242-130ALECENSAALECTINIB HYDROCHLORIDEGenentech, Inc.NDACurrent
50242-130ALECENSAALECTINIB HYDROCHLORIDEGenentech, Inc.NDACurrent
50242-130ALECENSAALECTINIB HYDROCHLORIDEGenentech, Inc.NDACurrent
50242-130ALECENSAALECTINIB HYDROCHLORIDEGenentech, Inc.NDACurrent
50242-130ALECENSAALECTINIB HYDROCHLORIDEGenentech, Inc.NDACurrent
50242-130ALECENSAALECTINIB HYDROCHLORIDEGenentech, Inc.NDACurrent
50242-130ALECENSAALECTINIB HYDROCHLORIDEGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78169SUPPL 2024-10-07
78180SUPPL 2024-04-19
78168SUPPL 2024-04-19
68576SUPPL2021-09-10
68552SUPPL2021-09-08
66057SUPPL2021-02-02
66035SUPPL2021-02-01
54555SUPPL2018-06-14
54554SUPPL2018-06-14
54485SUPPL2018-06-08
50356SUPPL2017-11-09
50314SUPPL2017-11-06
45846SUPPL2016-11-08
45826SUPPL2016-11-08
44975ORIG2016-01-28
43547ORIG2016-01-28
19995ORIG2015-12-11