Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125433
Company: JANSSEN BIOTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIMPONI ARIA GOLIMUMAB 50MG/4ML INJECTABLE; INJECTION 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
07/18/2013 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125433s000lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125433Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125433review.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/09/2018 SUPPL-24 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125433s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125433Orig1s024ltr.pdf
10/20/2017 SUPPL-21 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125433s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125433Orig1s020s021ltr.pdf
10/20/2017 SUPPL-20 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125433s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125433Orig1s020s021ltr.pdf
01/30/2017 SUPPL-19 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125433s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125433Orig1s019ltr.pdf
08/19/2016 SUPPL-18 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s018ltr.pdf
02/22/2016 SUPPL-17 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s017ltr.pdf
04/26/2016 SUPPL-16 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s016ltr.pdf
01/08/2016 SUPPL-15 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125433Orig1s015ltr.pdf
08/05/2015 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125433s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125433Orig1s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125433Orig1s14.pdf
12/19/2014 SUPPL-13 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125433Orig1s013ltr.pdf
02/12/2014 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125433s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125433Orig1s005ltr.pdf
02/04/2014 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125433s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125433Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/09/2018 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125433s024lbl.pdf
10/20/2017 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125433s020s021lbl.pdf
10/20/2017 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125433s020s021lbl.pdf
01/30/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125433s019lbl.pdf
08/19/2016 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433s018lbl.pdf
04/26/2016 SUPPL-16 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433Orig1s016lbl.pdf
02/22/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433Orig1s017lbl.pdf
02/22/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433Orig1s017lbl.pdf
01/08/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125433s015lbl.pdf
08/05/2015 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125433s014lbl.pdf
02/12/2014 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125433s005lbl.pdf
02/04/2014 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125433s002lbl.pdf
07/18/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125433s000lbledt.pdf

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