Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125261
Company: CENTOCOR ORTHO BIOTECH INC
Company: CENTOCOR ORTHO BIOTECH INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STELARA | USTEKINUMAB | 45MG/0.5ML | INJECTABLE; INJECTION | Prescription | None | No | No |
| STELARA | USTEKINUMAB | 90MG/1ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/25/2009 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2024 | SUPPL-163 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125261s163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125261Orig1s163; 761044Orig1s013ltr.pdf | |
| 07/29/2022 | SUPPL-161 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125261s161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125261Orig1s161ltr.pdf | |
| 03/06/2023 | SUPPL-158 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125261s158lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125261Orig1s158,761044Orig1s009ltr.pdf | |
| 12/11/2020 | SUPPL-157 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125261Orig1s157; 761044Orig1s008ltr.pdf |
| 12/01/2020 | SUPPL-154 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125261Orig1s154,761044Orig1s006ltr.pdf | |
| 04/06/2020 | SUPPL-153 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261Orig1s153, 761044s005lbl.pdf | |
| 10/18/2019 | SUPPL-152 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761044Orig1s003, 125261Orig1s152ltr.pdf |
| 07/29/2020 | SUPPL-150 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s150lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125261Orig1s150ltr.pdf | |
| 06/08/2018 | SUPPL-147 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s147lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125261Orig1s147ltr.pdf | |
| 11/07/2019 | SUPPL-142 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125261s142,761044s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125261Orig1s142, 761044Orig1s001ltr.pdf | |
| 02/16/2018 | SUPPL-141 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s141lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125261Orig1s141ltr.pdf | |
| 10/13/2017 | SUPPL-138 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125261s138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125261Orig1s138ltr.pdf | |
| 02/15/2017 | SUPPL-129 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125261Orig1s129ltr.pdf |
| 03/04/2014 | SUPPL-114 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125261s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125261Orig1s114ltr.pdf | |
| 09/20/2013 | SUPPL-103 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s103lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s103ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125261Orig1s103.pdf | |
| 04/29/2013 | SUPPL-99 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s099ltr.pdf | |
| 01/25/2013 | SUPPL-91 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s091ltr.pdf | |
| 05/21/2013 | SUPPL-86 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s086ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125261Orig1s086.pdf | |
| 05/02/2012 | SUPPL-63 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0063ltr.pdf |
| 06/14/2012 | SUPPL-59 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0059ltr.pdf | |
| 04/06/2012 | SUPPL-58 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0058ltr.pdf |
| 05/31/2012 | SUPPL-49 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0049ltr.pdf | |
| 10/20/2010 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125261s0013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125261s013ltr.pdf | |
| 12/30/2009 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s0001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/18/2024 | SUPPL-163 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125261s163lbl.pdf | |
| 03/06/2023 | SUPPL-158 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125261s158lbl.pdf | |
| 07/29/2022 | SUPPL-161 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125261s161lbl.pdf | |
| 12/01/2020 | SUPPL-154 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf | |
| 12/01/2020 | SUPPL-154 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf | |
| 07/29/2020 | SUPPL-150 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s150lbl.pdf | |
| 04/06/2020 | SUPPL-153 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261Orig1s153, 761044s005lbl.pdf | |
| 11/07/2019 | SUPPL-142 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125261s142,761044s001lbl.pdf | |
| 06/08/2018 | SUPPL-147 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s147lbl.pdf | |
| 02/16/2018 | SUPPL-141 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s141lbl.pdf | |
| 10/13/2017 | SUPPL-138 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125261s138lbl.pdf | |
| 03/04/2014 | SUPPL-114 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125261s114lbl.pdf | |
| 09/20/2013 | SUPPL-103 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s103lbl.pdf | |
| 05/21/2013 | SUPPL-86 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s086lbl.pdf | |
| 04/29/2013 | SUPPL-99 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s099lbl.pdf | |
| 01/25/2013 | SUPPL-91 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s091lbl.pdf | |
| 06/14/2012 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0059lbl.pdf | |
| 05/31/2012 | SUPPL-49 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125261s0049lbl.pdf | |
| 10/20/2010 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125261s0013lbl.pdf | |
| 12/30/2009 | SUPPL-1 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261s001lbl.pdf | |
| 09/25/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf |