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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761044
Company: JANSSEN BIOTECH

Medication Guide

Products on BLA 761044

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STELARA	USTEKINUMAB	130MG/26ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761044

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

Labels for BLA 761044

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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261s154,761044s006lbl.pdf
12/01/2020	SUPPL-6	Labeling-Package Insert	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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