FDA.reportPublic FDA data

Application 210951

Type
NDA
Sponsor
JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERLEADAAPALUTAMIDETABLET;ORAL60MGYesYes
002ERLEADAAPALUTAMIDETABLET;ORAL240MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent
59676-600ERLEADAApalutamideJanssen Products, LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85346SUPPL 2026-03-12
85291SUPPL 2026-03-09
79330SUPPL 2024-08-08
79312SUPPL 2024-08-05
79051SUPPL 2024-07-12
79031SUPPL 2024-07-10
77093SUPPL 2023-12-20
77091SUPPL 2023-12-20
73577SUPPL 2023-03-01
73556SUPPL 2023-02-17
72591SUPPL2022-11-10
72590SUPPL2022-11-10
72586SUPPL2022-11-09
72585SUPPL2022-11-09
70819SUPPL2022-04-27
70816SUPPL2022-04-26
68575SUPPL2021-09-10
68558SUPPL2021-09-08
68105SUPPL2021-07-16
68093SUPPL2021-07-15
65312SUPPL2020-11-25
65299SUPPL2020-11-23
64498SUPPL2020-09-04
64475SUPPL2020-09-02
63888SUPPL2020-07-14
63857SUPPL2020-07-13
60034SUPPL2019-09-18
60027SUPPL2019-09-17
53051ORIG2018-03-19
52643ORIG2018-02-14
52629ORIG2018-02-14