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 2026-08-01
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# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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