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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761061
Company: JANSSEN BIOTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TREMFYA GUSELKUMAB 100MG/ML 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
07/13/2017 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761061Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761061Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/11/2024 SUPPL-21 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761061s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761061Orig1s021ltr.pdf
06/29/2023 SUPPL-15 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761061s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761061Orig1s015ltr.pdf
06/01/2020 SUPPL-9 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761061Orig1s009ltr.pdf
07/13/2020 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761061Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761061Orig1s007.pdf
11/22/2019 SUPPL-4 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761061s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761061Orig1s004ltr.pdf
04/04/2019 SUPPL-2 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761061s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761061Orig1s002ltr.pdf
01/29/2019 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761061s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761061Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/11/2024 SUPPL-21 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761061s021lbl.pdf
06/29/2023 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761061s015lbl.pdf
06/29/2023 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761061s015lbl.pdf
07/13/2020 SUPPL-7 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s007lbl.pdf
06/01/2020 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf
11/22/2019 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761061s004lbl.pdf
04/04/2019 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761061s002lbl.pdf
01/29/2019 SUPPL-1 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761061s001lbl.pdf
07/13/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf
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