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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761379
Company: FRESENIUS KABI USA

Medication Guide

Products on BLA 761379

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OTULFI	USTEKINUMAB-AAUZ	45MG	INJECTABLE;INJECTION	Prescription	None	No	No
OTULFI	USTEKINUMAB-AAUZ	90MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761379

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761379Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761379Orig1s003ltr.pdf
03/21/2025	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761379Orig1s002ltr.pdf
04/14/2025	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 761379

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/21/2025	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig1s002lbl.pdf
02/19/2025	SUPPL-3		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s003lbl.pdf
09/27/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf

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