Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761044
Company: JANSSEN BIOTECH
Company: JANSSEN BIOTECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
STELARA | USTEKINUMAB | 130MG/26ML | 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 |
---|---|---|---|---|---|---|---|
09/23/2016 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761044Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761044Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/18/2024 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761044s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125261Orig1s163; 761044Orig1s013ltr.pdf | |
07/29/2022 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761044s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761044Orig1s010ltr.pdf | |
03/06/2023 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761044s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125261Orig1s158,761044Orig1s009ltr.pdf | |
12/11/2020 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761044s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125261Orig1s157; 761044Orig1s008ltr.pdf | |
12/01/2020 | SUPPL-6 | 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 | |
04/07/2020 | SUPPL-5 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261Orig1s153, 761044s005lbl.pdf | |
10/18/2019 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761044s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761044Orig1s003, 125261Orig1s152ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761044Orig1s003.pdf | |
11/07/2019 | SUPPL-1 | 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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/18/2024 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761044s013lbl.pdf | |
03/18/2024 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761044s013lbl.pdf | |
03/06/2023 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761044s009lbl.pdf | |
07/29/2022 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761044s010lbl.pdf | |
12/11/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761044s008lbl.pdf | |
12/01/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf | |
12/01/2020 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf | |
04/07/2020 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261Orig1s153, 761044s005lbl.pdf | |
11/07/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125261s142,761044s001lbl.pdf | |
10/18/2019 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761044s003lbl.pdf | |
09/23/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdf |