FDA.reportPublic FDA data

Application 213535

Type
NDA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVRYSDIRISDIPLAMPOWDER FOR ORAL SOLUTION1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-175EVRYSDIRisdiplamGenentech Inc.NDACurrent
50242-175EVRYSDIRisdiplamGenentech Inc.NDACurrent
50242-175EVRYSDIRisdiplamGenentech Inc.NDACurrent
50242-175EVRYSDIRisdiplamGenentech Inc.NDACurrent
50242-175EVRYSDIRisdiplamGenentech Inc.NDACurrent
50242-175EVRYSDIRisdiplamGenentech Inc.NDACurrent
50242-175EVRYSDIRisdiplamGenentech Inc.NDACurrent
50242-175EVRYSDIRisdiplamGenentech Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85090SUPPL 2026-02-20
85089SUPPL 2026-02-20
84841SUPPL 2026-01-27
84821SUPPL 2026-01-22
81248SUPPL 2025-02-14
81229SUPPL 2025-02-12
79658SUPPL 2024-09-19
79649SUPPL 2024-09-18
77684SUPPL 2024-03-01
77679SUPPL 2024-03-01
75674SUPPL 2023-10-05
73877SUPPL 2023-03-27
73871SUPPL 2023-03-27
72151SUPPL2022-09-23
72138SUPPL2022-09-22
71196SUPPL2022-06-01
71195SUPPL2022-06-01
71175SUPPL2022-05-31
71174SUPPL2022-05-31
67406SUPPL2021-05-05
67396SUPPL2021-05-04
64492ORIG2020-09-04
64248ORIG2020-08-10
64246ORIG2020-08-03