FDA.reportPublic FDA data

Application 761044

Type
BLA
Sponsor
JANSSEN BIOTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761044Stelaraustekinumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STELARAUSTEKINUMABINJECTABLE;INJECTION130MG/26MLNoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StelaraUSTEKINUMABJanssen Biotech, Inc.c77a9664-e3bb-4023-b400-127aa53bca2b2026-09-08Warnings, Adverse reactionsExact identifier
application number: BLA761044
ndc (product): 57894-054
ustekinumabUSTEKINUMABJanssen Biotech, Inc.23b486eb-f48d-47d4-815e-1313d4ebfbfa2026-08-31Warnings, Adverse reactionsExact identifier
application number: BLA761044

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent
57894-054StelaraustekinumabJanssen Biotech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85701SUPPL 2026-04-20
85702SUPPL 2026-04-16
85694SUPPL 2026-04-16
84062SUPPL 2025-11-04
84050SUPPL 2025-11-04
82730SUPPL 2025-07-03
82692SUPPL 2025-06-30
81871SUPPL 2025-04-08
81810SUPPL 2025-04-02
80240SUPPL 2024-11-19
77901SUPPL 2024-03-21
77874SUPPL 2024-03-19
73702SUPPL 2023-03-07
73698SUPPL 2023-03-07
71677SUPPL2022-08-01
71676SUPPL2022-08-01
71673SUPPL2022-08-01
68781SUPPL2021-09-24
65593SUPPL2020-12-15
65581SUPPL2020-12-14
65580SUPPL2020-12-14
65467SUPPL2020-12-02
65459SUPPL2020-12-01
65458SUPPL2020-12-01
62547SUPPL2020-04-13
62546SUPPL2020-04-13
60840SUPPL2019-11-14
60839SUPPL2019-11-14
60808SUPPL2019-11-12
60598SUPPL2019-10-24
60608SUPPL2019-10-21
60607SUPPL2019-10-21
51048ORIG2018-01-12
45422ORIG2016-09-29
45480ORIG2016-09-26