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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125433
Company: JANSSEN BIOTECH

Medication Guide

Products on BLA 125433

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125433

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
02/01/2021	SUPPL-32	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125433s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125433Orig1s032ltr.pdf
09/29/2020	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125433s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125433Orig1s030,s031ltr.pdf
09/29/2020	SUPPL-30	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125433Orig1s030,s031ltr.pdf
09/24/2019	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125433s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125433Orig1s028ltr.pdf
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

Labels for BLA 125433

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2021	SUPPL-32	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125433s032lbl.pdf
09/29/2020	SUPPL-31	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125433s030s031lbl.pdf
09/24/2019	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125433s028lbl.pdf
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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