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FDA BLA · BLA761322

TYRUKO

natalizumab-sztn

Sponsor: SANDOZ INC

APPLICATION
BLA761322
TYPE
BLA
ORIGINAL APPROVAL
2023-08-24
LATEST ACTION
2026-07-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TYRUKOPrescription
NATALIZUMAB-SZTN 300MG/15ML(20MG/ML) · INJECTABLE · INJECTION

Approval history

2026-07-23REMS · Supplement 8LetterAP
2026-02-02REMS · Supplement 7AP
2025-10-30Labeling · Supplement 2 · standardLabelAP
2023-08-24Type 2 - New Active Ingredient · Original · standardLabelAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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