Application 761105

Type
BLA
Sponsor
ABBVIE INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761105Skyrizirisankizumab-rzaa351(a)Disc2026-06-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SkyriziRISANKIZUMAB-RZAAAbbVie Inc.7148c8eb-b39e-e20a-6494-a6df823928582026-06-15Warnings, Adverse reactionsExact identifier
application number: BLA761105
ndc (product): 0074-1050
ndc (product): 0074-2042
ndc (product): 0074-1070
ndc (product): 0074-5015
ndc (product): 0074-2100
ndc (product): 0074-1065

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

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