FDA.reportPublic FDA data

Application 103772

Type
BLA
Sponsor
CENTOCOR INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103772Remicadeinfliximab351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REMICADEINFLIXIMABVIAL100MGNoNo

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
INFLIXIMABINFLIXIMABJanssen Biotech, Inc.b05c174f-832c-4321-b34f-2c4ad37422692026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103772
ndc (product): 57894-160
REMICADEINFLIXIMABJanssen Biotech, Inc.a0a046c1-056d-45a9-bfd9-13b47c24f2572025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103772
ndc (product): 57894-030

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57894-030REMICADEINFLIXIMABJanssen Biotech, Inc.BLACurrent
57894-030REMICADEINFLIXIMABJanssen Biotech, Inc.BLACurrent
57894-030REMICADEINFLIXIMABJanssen Biotech, Inc.BLACurrent
57894-030REMICADEINFLIXIMABJanssen Biotech, Inc.BLACurrent
57894-030REMICADEINFLIXIMABJanssen Biotech, Inc.BLACurrent
57894-160INFLIXIMABINFLIXIMABJanssen Biotech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81432SUPPL 2025-03-04
81401SUPPL 2025-03-03
81400SUPPL 2025-03-03
69800SUPPL2021-12-29
68895SUPPL2021-10-06
68894SUPPL2021-10-06
63040SUPPL2020-05-15
63039SUPPL2020-05-15
63038SUPPL2020-05-15
63023SUPPL2020-05-15
63022SUPPL2020-05-15
63021SUPPL2020-05-15
63020SUPPL2020-05-15
63019SUPPL2020-05-15
63018SUPPL2020-05-15
54688SUPPL2018-06-26
54687SUPPL2018-06-26
54644SUPPL2018-06-21
50223SUPPL2017-10-30
50189SUPPL2017-10-26
22746SUPPL2016-01-19
18646SUPPL2015-10-08
31656SUPPL2015-10-06
9453SUPPL2015-09-01
18647SUPPL2015-08-28
31655SUPPL2015-01-07
39704SUPPL2015-01-05
18645SUPPL2013-11-08
9452SUPPL2013-11-08
39703SUPPL2013-04-01
31654SUPPL2013-03-29
9451SUPPL2012-06-29
18644SUPPL2012-03-15
22747SUPPL2012-02-14
39702SUPPL2011-09-30
9449SUPPL2011-09-29
9450SUPPL2011-08-11
18643SUPPL2011-03-04
9448SUPPL2011-02-28
39700SUPPL2011-01-06
31651SUPPL2011-01-06
18642SUPPL2010-08-28
31653SUPPL2010-08-03
31652SUPPL2010-05-10
39701SUPPL2010-05-07
9447SUPPL2009-11-25
31650SUPPL2009-05-08
18641SUPPL2009-05-07
39699SUPPL2009-04-20
9446SUPPL2009-04-20
43283SUPPL2008-04-02
22745SUPPL2007-08-06
31649SUPPL2007-07-05
18640SUPPL2007-07-05
39697SUPPL2007-04-25
31647SUPPL2007-04-25
18635SUPPL2007-02-23
31645SUPPL2007-02-12
18638SUPPL2007-01-08
9444SUPPL2007-01-08
18637SUPPL2006-10-23
9443SUPPL2006-10-23
39698SUPPL2006-08-18
18639SUPPL2006-08-18
31648SUPPL2006-08-14
9445SUPPL2006-08-14
44422ORIG2006-05-19
31646SUPPL2006-05-19
18636SUPPL2006-05-19
9442SUPPL2005-10-20
18634SUPPL2005-09-20
39695SUPPL2005-05-20
31643SUPPL2005-05-20
39696SUPPL2005-04-12
9441SUPPL2005-04-12
31644SUPPL2005-03-03
39694SUPPL2004-12-29
31642SUPPL2004-12-29
31641SUPPL2004-10-05
23080SUPPL2004-09-29
18633SUPPL2004-09-29
43281ORIG2004-09-22
39691ORIG2004-09-22
9435ORIG2004-09-22
18632SUPPL2004-08-10
9440SUPPL2004-08-10
43282SUPPL2004-03-26
39693SUPPL2004-03-26
39692SUPPL2004-03-26
31639SUPPL2004-03-26
31638SUPPL2004-03-26
18631SUPPL2004-03-26
18630SUPPL2004-03-26
9439SUPPL2004-03-26
9437SUPPL2004-03-26
9436SUPPL2004-03-26
31640SUPPL2003-11-03
9438SUPPL2003-11-03