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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761044
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
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