FDA.reportPublic FDA data

Application 203415

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XTANDIENZALUTAMIDECAPSULE;ORAL40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-0125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-0125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-1125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent
0469-1125XtandienzalutamideAstellas Pharma US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84446SUPPL 2025-12-18
84396SUPPL 2025-12-12
81709SUPPL 2025-03-25
81708SUPPL 2025-03-25
81705SUPPL 2025-03-24
80925SUPPL 2025-02-12
81140SUPPL 2025-02-07
76628SUPPL 2023-11-17
76593SUPPL 2023-11-17
72072SUPPL2022-09-13
72064SUPPL2022-09-12
69923SUPPL2022-01-19
69890SUPPL2022-01-18
65042SUPPL2020-10-27
65032SUPPL2020-10-27
61341SUPPL2019-12-19
61285SUPPL2019-12-16
54897SUPPL2018-07-16
54886SUPPL2018-07-13
49101SUPPL2017-07-27
49082SUPPL2017-07-25
45629SUPPL2016-10-21
45577SUPPL2016-10-20
10214SUPPL2015-10-09
19468SUPPL2015-10-08
19467SUPPL2015-09-21
32422SUPPL2015-08-10
40297SUPPL2015-07-22
10213SUPPL2015-07-22
10212SUPPL2014-09-16
40296SUPPL2014-09-10
19466SUPPL2013-03-26
44882ORIG2012-09-12
43431ORIG2012-09-12
32421ORIG2012-09-05
19465ORIG2012-08-31