Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103772
Company: CENTOCOR INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REMICADE INFLIXIMAB 100MG VIAL Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/24/1998 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/inflcen082498lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/inflcen082498L.htm https://web.archive.org/web/20170118085130/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093327.htm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/19/2018 SUPPL-5385 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103772s5385lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103772Orig1s5385ltr.pdf
10/25/2017 SUPPL-5377 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103772s5377lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103772Orig1s05377ltr.pdf
08/27/2015 SUPPL-5374 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5374lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5374ltr.pdf
10/02/2015 SUPPL-5373 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5373lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5373ltr.pdf
01/02/2015 SUPPL-5370 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5370lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103772Orig1s5370ltr.pdf
11/06/2013 SUPPL-5359 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5359lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5359ltr.pdf
03/28/2013 SUPPL-5345 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103772Orig1s5345ltr.pdf
06/28/2012 SUPPL-5328 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103772s5328ltr.pdf
08/01/2011 SUPPL-5317 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5317ltr.pdf
09/07/2011 SUPPL-5314 Supplement

Label is not available on this site.

09/23/2011 SUPPL-5301 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5301lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5301ltr.pdf
10/26/2011 SUPPL-5295 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5295lbl.pdf
10/04/2010 SUPPL-5285 Supplement

Label is not available on this site.

02/17/2011 SUPPL-5281 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5281lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103772s5281ltr.pdf
07/29/2010 SUPPL-5278 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5278ltr.pdf
04/26/2010 SUPPL-5260 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5260lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5260ltr.pdf
12/28/2010 SUPPL-5259 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5259lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103772s5259ltr.pdf
11/18/2009 SUPPL-5258 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103772s5258ltr.pdf
05/05/2009 SUPPL-5234 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5234lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103772s5234ltr.pdf
12/22/2008 SUPPL-5232 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103772s5232lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103772s5232ltr.pdf
08/06/2008 SUPPL-5208 Supplement

Label is not available on this site.

05/19/2008 SUPPL-5206 Supplement

Label is not available on this site.

06/12/2007 SUPPL-5189 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5189lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5189ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/103772Orig1s5189Approv.pdf
08/11/2006 SUPPL-5167 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5166s5167ltr.pdf
08/11/2006 SUPPL-5166 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5166s5167ltr.pdf
12/08/2006 SUPPL-5163 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5163ltr.pdf
04/19/2007 SUPPL-5160 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5160_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5160_LTR.pdf
10/13/2006 SUPPL-5145 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5145LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5145LTR.pdf
05/19/2006 SUPPL-5138 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103772s5138ltr.pdf
03/17/2006 SUPPL-5135 Supplement

Label is not available on this site.

09/26/2006 SUPPL-5129 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103772s5129ltr.pdf
09/15/2005 SUPPL-5113 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5113lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5113ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103772Orig1s5113.pdf
04/05/2005 SUPPL-5092 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772_5092_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772_5092ltr.pdf
12/17/2004 SUPPL-5090 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5090_ltr.pdf
05/13/2005 SUPPL-5089 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103772s5089ltr.pdf
10/07/2004 SUPPL-5083 Supplement

Label is not available on this site.

12/17/2004 SUPPL-5077 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5077_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5077_ltr.pdf
09/29/2004 SUPPL-5073 Supplement Label (PDF)
Letter (PDF)
Patient Package Insert (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5073ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073ppi.pdf
03/10/2004 SUPPL-5069 Supplement

Label is not available on this site.

07/29/2004 SUPPL-5058 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103772_5058ltr.pdf
09/03/2003 SUPPL-5056 Supplement Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103772-5056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/103772_S5056_REMIICADE.pdf
07/03/2003 SUPPL-5049 Supplement

Label is not available on this site.

07/14/2003 SUPPL-5047 Supplement

Label is not available on this site.

04/01/2003 SUPPL-5032 Supplement Letter

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/inflcen040103L.htm
09/03/2003 SUPPL-5020 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103772-5020ltr.pdf
06/28/2002 SUPPL-5012 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen062802LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/inflcen062802L.pdf
11/27/2001 SUPPL-5006 Supplement

Label is not available on this site.

02/27/2002 SUPPL-5004 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen022702LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/inflcen022702L.pdf
12/29/2000 SUPPL-1007 Supplement Label (PDF)
Letter
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen122900LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/inflcen122900L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/103772_S1007_REMICADE.pdf
11/10/1999 SUPPL-1004 Supplement Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen111099lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/inflcen111099L.htm https://web.archive.org/web/20170118085130/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093335.htm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/19/2018 SUPPL-5385 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103772s5385lbl.pdf
10/25/2017 SUPPL-5377 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103772s5377lbl.pdf
10/02/2015 SUPPL-5373 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5373lbl.pdf
08/27/2015 SUPPL-5374 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5374lbl.pdf
01/02/2015 SUPPL-5370 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103772s5370lbl.pdf
11/06/2013 SUPPL-5359 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5359lbl.pdf
03/28/2013 SUPPL-5345 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103772s5345lbl.pdf
10/26/2011 SUPPL-5295 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5295lbl.pdf
09/23/2011 SUPPL-5301 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5301lbl.pdf
02/17/2011 SUPPL-5281 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103772s5281lbl.pdf
12/28/2010 SUPPL-5259 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5259lbl.pdf
04/26/2010 SUPPL-5260 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103772s5260lbl.pdf
11/18/2009 SUPPL-5258 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5258lbl.pdf
05/05/2009 SUPPL-5234 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5234lbl.pdf
12/22/2008 SUPPL-5232 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103772s5232lbl.pdf
06/12/2007 SUPPL-5189 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5189lbl.pdf
04/19/2007 SUPPL-5160 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5160_LBL.pdf
12/08/2006 SUPPL-5163 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5163lbl.pdf
10/13/2006 SUPPL-5145 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5145LBL.pdf
09/26/2006 SUPPL-5129 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103772s5129lbl.pdf
08/11/2006 SUPPL-5167 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf
08/11/2006 SUPPL-5166 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5166, 103772s5167LBL.pdf
05/19/2006 SUPPL-5138 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103772s5138lbl.pdf
09/15/2005 SUPPL-5113 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5113lbl.pdf
05/13/2005 SUPPL-5089 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772s5089lbl.pdf
04/05/2005 SUPPL-5092 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103772_5092_LBL.pdf
12/17/2004 SUPPL-5077 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5077_lbl.pdf
09/29/2004 SUPPL-5073 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772s5073lbl.pdf
07/29/2004 SUPPL-5058 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103772_5058lbl.pdf
06/28/2002 SUPPL-5012 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen062802LB.pdf
02/27/2002 SUPPL-5004 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/inflcen022702LB.pdf
12/29/2000 SUPPL-1007 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen122900LB.pdf
11/10/1999 SUPPL-1004 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/inflcen111099lb.pdf
08/24/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/inflcen082498lb.pdf

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