Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761180
Company: LEO PHARMA AS

Products on BLA 761180

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADBRY	TRALOKINUMAB	150MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761180

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
06/02/2023	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

Labels for BLA 761180

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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