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Biologic License Application (BLA): 761180
Company: LEO PHARMA AS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADBRY TRALOKINUMAB 150MG/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
12/27/2021 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761180Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761180Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/2024 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761180s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761180Orig1s006ltr.pdf
06/02/2023 SUPPL-5 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761180Orig1s005ltr.pdf
07/27/2022 SUPPL-2 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761180Orig1s002ltr.pdf
12/14/2023 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761180s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761180Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/12/2024 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761180s006lbl.pdf
12/14/2023 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761180s001lbl.pdf
12/27/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761180lbl.pdf
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