Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125433
Company: JANSSEN BIOTECH
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 |
---|---|---|---|---|---|
02/01/2021 | 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 |
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 |