Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761322
Company: SANDOZ INC

• Medication Guide

• REMS

Products on BLA 761322

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYRUKO	NATALIZUMAB-SZTN	300MG/15ML(20MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761322

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/2023	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761322s000lblcorrection.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761322Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761322Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2026	SUPPL-7	Supplement		Label is not available on this site.
10/30/2025	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761322s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761322Orig1s002ltr.pdf

Labels for BLA 761322

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2025	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761322s002lbl.pdf
10/30/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761322s002lbl.pdf
08/24/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761322s000lblcorrection.pdf