FDA.reportPublic FDA data

Application 125289

Type
BLA
Sponsor
CENTOCOR ORTHO BIOTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125289Simponigolimumab351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIMPONIGOLIMUMABINJECTABLE; INJECTION50MGYesNo

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
SimponiGOLIMUMABJanssen Biotech, Inc.f86cb4a7-c358-4136-ae57-b32bda9bba002025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125289
ndc (product): 57894-071
ndc (product): 57894-070

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57894-070SimponigolimumabJanssen Biotech, Inc.BLACurrent
57894-070SimponigolimumabJanssen Biotech, Inc.BLACurrent
57894-071SimponigolimumabJanssen Biotech, Inc.BLACurrent
57894-071SimponigolimumabJanssen Biotech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83907SUPPL 2025-10-23
83906SUPPL 2025-10-23
83900SUPPL 2025-10-23
83684SUPPL 2025-10-07
83677SUPPL 2025-10-07
83639SUPPL 2025-10-03
83610SUPPL 2025-10-01
82793SUPPL 2025-07-11
82002SUPPL 2025-04-25
76616SUPPL 2023-11-17
73919SUPPL 2023-03-31
73912SUPPL 2023-03-31
60109SUPPL2019-09-25
60101SUPPL2019-09-25
60100SUPPL2019-09-25
52911SUPPL2018-03-12
52877SUPPL2018-03-08
52549SUPPL2018-02-09
52531SUPPL2018-02-09
50426SUPPL2017-11-15
50406SUPPL2017-11-14
48804SUPPL2017-06-22
48802SUPPL2017-06-22
48418SUPPL2017-05-17
47055SUPPL2017-01-31
47062SUPPL2017-01-30
18852SUPPL2016-01-12
31906SUPPL2016-01-11
39906SUPPL2015-06-19
31905SUPPL2015-06-18
31904SUPPL2014-12-23
22798SUPPL2014-08-01
31902SUPPL2013-12-31
18851SUPPL2013-12-30
39904SUPPL2013-11-15
31901SUPPL2013-11-14
39902SUPPL2013-05-21
18849SUPPL2013-05-21
18848SUPPL2013-05-21
31899SUPPL2013-05-16
31898SUPPL2013-05-16
9683SUPPL2013-05-16
9684SUPPL2013-05-08
18850SUPPL2013-05-06
39903SUPPL2013-04-30
31900SUPPL2013-04-30
39901SUPPL2012-11-28
9682SUPPL2012-11-26
39900SUPPL2012-03-15
31896SUPPL2012-01-24
39899SUPPL2012-01-11
31897SUPPL2012-01-03
23950ORIG2011-12-20
9681SUPPL2011-09-13
31895SUPPL2011-03-25
9679SUPPL2011-01-06
18847SUPPL2011-01-05
9680SUPPL2010-10-19
39898SUPPL2010-08-10
9678SUPPL2010-08-03
18846SUPPL2009-12-11
9677SUPPL2009-11-25
44797ORIG2009-06-05
43315ORIG2009-06-05
9676ORIG2009-05-06
39897ORIG2009-05-05
51154SUPPL1900-01-01
51153SUPPL1900-01-01
51152SUPPL1900-01-01
51151SUPPL1900-01-01