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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761061
Company: JANSSEN BIOTECH

Medication Guide

Products on BLA 761061

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TREMFYA	GUSELKUMAB	100MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761061

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

Labels for BLA 761061

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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