FDA.reportPublic FDA data

Application 212099

Type
NDA
Sponsor
BAYER HEALTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUBEQADAROLUTAMIDETABLET;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-395NUBEQAdarolutamideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-395NUBEQAdarolutamideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-395NUBEQAdarolutamideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-395NUBEQAdarolutamideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-395NUBEQAdarolutamideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-395NUBEQAdarolutamideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-395NUBEQAdarolutamideBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-395NUBEQAdarolutamideBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82460SUPPL 2025-06-05
82466SUPPL 2025-06-04
75780SUPPL 2023-10-16
75732SUPPL 2023-10-16
71775SUPPL2022-08-11
71739SUPPL2022-08-08
65873SUPPL2021-01-08
65871SUPPL2021-01-08
59870ORIG2019-08-29
59521ORIG2019-07-31
59518ORIG2019-07-31