FDA.reportPublic FDA data

Application 103772

Type
BLA
Sponsor
CENTOCOR INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REMICADEINFLIXIMABVIAL100MGNoNo

NDC Listings For This Application#

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