Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125289
Company: CENTOCOR ORTHO BIOTECH INC
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 |
|---|---|---|---|---|---|
| 11/16/2023 | SUPPL-153 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125289Orig1s153ltr.pdf |
| 03/30/2023 | SUPPL-150 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125289s150lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125289Orig1s150ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 03/30/2023 | SUPPL-150 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125289s150lbl.pdf | |
| 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 |