Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125289
Company: CENTOCOR ORTHO BIOTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIMPONI GOLIMUMAB 50MG INJECTABLE; INJECTION Prescription None TBD 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
04/24/2009 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125289s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125289s0000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125289s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2019 SUPPL-146 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125289Orig1s146ltr.pdf
02/09/2018 SUPPL-141 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125289s141lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125289Orig1s141ltr.pdf
03/06/2018 SUPPL-139 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125289s139lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125289Orig1s139ltr.pdf
11/13/2017 SUPPL-137 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125289s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125289Orig1s137ltr.pdf
01/30/2017 SUPPL-135 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125289s135lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125289Orig1s135ltr.pdf
06/22/2017 SUPPL-133 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125289s133lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125289Orig1s133ltr.pdf
01/08/2016 SUPPL-127 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125289s127lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125289Orig1s127ltr.pdf
06/16/2015 SUPPL-124 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125289s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125289Orig1s124ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125289s124.pdf
12/19/2014 SUPPL-121 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125289Orig1s121ltr.pdf
01/24/2014 SUPPL-105 Supplement

Label is not available on this site.

12/27/2013 SUPPL-103 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s103ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2013/125289Orig1s103.pdf
11/13/2013 SUPPL-94 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s094ltr.pdf
05/06/2013 SUPPL-86 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s086ltr.pdf
04/23/2013 SUPPL-84 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s084ltr.pdf
05/15/2013 SUPPL-79 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s077,s078,s079ltr.pdf
05/15/2013 SUPPL-78 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s077,s078,s079ltr.pdf
05/15/2013 SUPPL-77 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125289Orig1s077,s078,s079ltr.pdf
11/23/2012 SUPPL-70 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125289s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125289Orig1s070ltr.pdf
12/26/2011 SUPPL-64 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s064ltr.pdf
09/07/2011 SUPPL-53 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s053ltr.pdf
08/17/2011 SUPPL-38 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s038ltr.pdf
09/29/2010 SUPPL-33 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125289s033ltr.pdf
12/22/2010 SUPPL-29 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s0029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125289s0029ltr.pdf
07/29/2010 SUPPL-25 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125289s025ltr.pdf
03/17/2011 SUPPL-20 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125289s0020ltr.pdf
11/18/2009 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125289s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/24/2019 SUPPL-146 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125289s146lbl.pdf
03/06/2018 SUPPL-139 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125289s139lbl.pdf
02/09/2018 SUPPL-141 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125289s141lbl.pdf
11/13/2017 SUPPL-137 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125289s037lbl.pdf
06/22/2017 SUPPL-133 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125289s133lbl.pdf
01/30/2017 SUPPL-135 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125289s135lbl.pdf
01/08/2016 SUPPL-127 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125289s127lbl.pdf
06/16/2015 SUPPL-124 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125289s024lbl.pdf
12/27/2013 SUPPL-103 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s103lbl.pdf
11/13/2013 SUPPL-94 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s094lbl.pdf
05/15/2013 SUPPL-79 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf
05/15/2013 SUPPL-78 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf
05/15/2013 SUPPL-77 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s077s078s079lbl.pdf
05/06/2013 SUPPL-86 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s086lbl.pdf
04/23/2013 SUPPL-84 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125289s084lbl.pdf
11/23/2012 SUPPL-70 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125289s070lbl.pdf
12/26/2011 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0064lbl.pdf
08/17/2011 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125289s0038lbl.pdf
12/22/2010 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s0029lbl.pdf
07/29/2010 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125289s025lbl.pdf
11/18/2009 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s006lbl.pdf
04/24/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s000lbl.pdf

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