Application 761105

Type
BLA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SKYRIZIRISANKIZUMAB-RZAAINJECTABLE;INJECTION75MG/0.83MLNoNo
002SKYRIZIRISANKIZUMAB-RZAAINJECTABLE;INJECTION150MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1050Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1065SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1065SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1070SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1070SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1070SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1070SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1070SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1070SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-1070SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2042SkyriziRisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-2100Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent
0074-5015Skyrizirisankizumab-rzaaAbbVie Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85490SUPPL 2026-03-24
85437SUPPL 2026-03-20
85343SUPPL 2026-03-12
85308SUPPL 2026-03-09
83295SUPPL 2025-09-05
83294SUPPL 2025-09-05
83281SUPPL 2025-09-04
82183SUPPL 2025-05-14
78856SUPPL 2024-06-20
78847SUPPL 2024-06-20
78137SUPPL 2024-04-15
77729SUPPL 2024-03-06
77719SUPPL 2024-03-05
77188SUPPL 2024-01-04
77182SUPPL 2024-01-04
72846SUPPL2022-12-09
72845SUPPL2022-12-09
72156SUPPL2022-09-27
72155SUPPL2022-09-27
72153SUPPL2022-09-26
71356SUPPL2022-06-21
71348SUPPL2022-06-17
69970SUPPL2022-01-26
69969SUPPL2022-01-25
69962SUPPL2022-01-25
67198SUPPL2021-04-28
67197SUPPL2021-04-28
67196SUPPL2021-04-28
67186SUPPL2021-04-27
67185SUPPL2021-04-27
62266SUPPL2020-03-23
62223SUPPL2020-03-23
62222SUPPL2020-03-23
58883ORIG2019-05-30
58452ORIG2019-04-29
58370ORIG2019-04-23
58369ORIG2019-04-23