Home Applications 761322 Application 761322
Type BLA
Sponsor SANDOZ INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761322 Tyruko natalizumab-sztn 351(k) Biosimilar Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TYRUKO NATALIZUMAB-SZTN INJECTABLE;INJECTION 300MG/15ML(20MG/ML) No No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYRUKO NATALIZUMAB-SZTN Sandoz Inc ef653c36-dd4b-4e71-9d2d-40b8fea24b67 2025-10-31 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761322
Documents# Document, Submission type, Date table Document Submission type Date 84035 SUPPL 2025-11-03 84030 SUPPL 2025-10-31 84029 SUPPL 2025-10-31 76274 ORIG 2023-11-03 75705 ORIG 2023-10-11 75293 ORIG 2023-10-11 75284 ORIG 2023-08-24