FDA.reportPublic FDA data

Application 213674

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XTANDIENZALUTAMIDETABLET, FILM COATED40MGYesNo
002XTANDIENZALUTAMIDETABLET, FILM COATED80MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-0625XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0625XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0625XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0625XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0625XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0625XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0725XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0725XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0725XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0725XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0725XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0725XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-1725XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-1725XtandienzalutamideAstellas Pharma US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84454SUPPL 2025-12-18
84397SUPPL 2025-12-12
81710SUPPL 2025-03-25
81706SUPPL 2025-03-24
80924SUPPL 2025-02-12
81146SUPPL 2025-02-07
76627SUPPL 2023-11-17
76592SUPPL 2023-11-17
72073SUPPL2022-09-13
72065SUPPL2022-09-12
69924SUPPL2022-01-19
69891SUPPL2022-01-18
67588SUPPL2021-05-25
67587SUPPL2021-05-25
65975ORIG2021-01-25
64201ORIG2020-08-05