FDA.reportPublic FDA data

Application 125261

Type
BLA
Sponsor
CENTOCOR ORTHO BIOTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125261Stelaraustekinumab351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STELARAUSTEKINUMABINJECTABLE; INJECTION45MG/0.5MLNoNo
002STELARAUSTEKINUMABINJECTABLE; INJECTION90MG/1MLNoNo

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
ustekinumabUSTEKINUMABJanssen Biotech, Inc.23b486eb-f48d-47d4-815e-1313d4ebfbfa2026-07-23Warnings, Adverse reactionsExact identifier
application number: BLA125261
StelaraUSTEKINUMABJanssen Biotech, Inc.c77a9664-e3bb-4023-b400-127aa53bca2b2026-07-21Warnings, Adverse reactionsExact identifier
application number: BLA125261
ndc (product): 57894-061
ndc (product): 57894-060

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-060STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent
57894-061STELARAustekinumabJanssen Biotech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85703SUPPL 2026-04-20
85704SUPPL 2026-04-16
85695SUPPL 2026-04-16
84061SUPPL 2025-11-04
84049SUPPL 2025-11-04
84048SUPPL 2025-11-04
82732SUPPL 2025-07-03
82691SUPPL 2025-06-30
81870SUPPL 2025-04-08
81809SUPPL 2025-04-02
80239SUPPL 2024-11-19
80228SUPPL 2024-11-18
77899SUPPL 2024-03-21
77873SUPPL 2024-03-19
73700SUPPL 2023-03-07
73697SUPPL 2023-03-07
71694SUPPL2022-08-02
71693SUPPL2022-08-02
71672SUPPL2022-08-01
65592SUPPL2020-12-15
65466SUPPL2020-12-02
65457SUPPL2020-12-01
65456SUPPL2020-12-01
64137SUPPL2020-07-30
64136SUPPL2020-07-30
64132SUPPL2020-07-30
64407SUPPL2020-04-07
62464SUPPL2020-04-07
60999SUPPL2019-11-20
60838SUPPL2019-11-14
60837SUPPL2019-11-14
60807SUPPL2019-11-12
60744SUPPL2019-10-31
60599SUPPL2019-10-24
54589SUPPL2018-06-14
54540SUPPL2018-06-12
54539SUPPL2018-06-12
52700SUPPL2018-02-23
52685SUPPL2018-02-22
50125SUPPL2017-10-20
50084SUPPL2017-10-18
48148SUPPL2017-04-27
9656SUPPL2014-03-06
39885SUPPL2014-03-05
39884SUPPL2013-09-24
9655SUPPL2013-09-23
39882SUPPL2013-05-23
9653SUPPL2013-05-23
18826SUPPL2013-05-01
9654SUPPL2013-05-01
39883SUPPL2013-01-30
31874SUPPL2013-01-30
39881SUPPL2012-06-18
9652SUPPL2012-06-15
39880SUPPL2012-06-06
31871SUPPL2012-06-04
31873SUPPL2012-05-04
31872SUPPL2012-04-11
39879SUPPL2012-04-09
9651SUPPL2010-12-28
39878SUPPL2010-01-29
9650SUPPL2010-01-27
43312ORIG2010-01-22
24358ORIG2010-01-22
31870ORIG2009-10-05
39877ORIG2009-09-29
63283ORIG1900-01-01
51691SUPPL1900-01-01
51690SUPPL1900-01-01
51689SUPPL1900-01-01
51688SUPPL1900-01-01