FDA.reportPublic FDA data

Application 125160

Type
BLA
Sponsor
UCB INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125160Cimziacertolizumab pegol351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIMZIACERTOLIZUMAB PEGOLINJECTABLE; INJECTION200MGNoNo

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
CimziaCERTOLIZUMAB PEGOLUCB, Inc.b4c2c9dc-a0bb-4d64-a667-a67ebe88392d2026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125160
ndc (product): 50474-700
ndc (product): 50474-710

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50474-700Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-700Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-700Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-700Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-700Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-700Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-710Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-710Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-710Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-710Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-710Cimziacertolizumab pegolUCB, Inc.BLACurrent
50474-710Cimziacertolizumab pegolUCB, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83473SUPPL 2025-09-25
83472SUPPL 2025-09-25
83426SUPPL 2025-09-24
79633SUPPL 2024-09-16
79600SUPPL 2024-09-16
76563SUPPL 2023-11-14
74208SUPPL 2023-05-10
73046SUPPL2022-12-27
73045SUPPL2022-12-27
73023SUPPL2022-12-23
65850SUPPL2021-01-07
60743SUPPL2019-10-31
59946SUPPL2019-09-09
59945SUPPL2019-09-09
59940SUPPL2019-09-09
58923SUPPL2019-06-03
58186SUPPL2019-04-02
58185SUPPL2019-04-02
58155SUPPL2019-03-29
57843SUPPL2019-02-28
57832SUPPL2019-02-28
57844SUPPL2019-02-27
54361SUPPL2018-05-29
54351SUPPL2018-05-29
54350SUPPL2018-05-29
53486SUPPL2018-03-28
53481SUPPL2018-03-28
46677SUPPL2017-01-05
46671SUPPL2017-01-05
9640SUPPL2016-05-04
39868SUPPL2016-04-29
18819SUPPL2016-02-11
9641SUPPL2016-02-04
39869SUPPL2015-10-22
31860SUPPL2015-10-21
18818SUPPL2013-10-22
9639SUPPL2013-10-18
18817SUPPL2013-10-01
9638SUPPL2013-10-01
22792SUPPL2013-09-09
31858SUPPL2012-11-16
18816SUPPL2012-11-16
31859SUPPL2012-10-10
9637SUPPL2012-10-10
39867SUPPL2012-10-09
39866SUPPL2012-10-09
39865SUPPL2012-08-31
31857SUPPL2012-08-31
9635SUPPL2012-08-06
39864SUPPL2012-08-03
31856SUPPL2012-04-23
18815SUPPL2012-04-20
9636SUPPL2011-09-13
9634SUPPL2010-11-04
18814SUPPL2010-08-10
31855SUPPL2010-08-02
18813SUPPL2009-12-12
9633SUPPL2009-12-02
31854SUPPL2009-01-30
23949ORIG2008-09-04
44792ORIG2008-07-14
22791ORIG2008-07-07
18812ORIG2008-05-08
9632ORIG2008-04-30