Home Applications 761449 Application 761449
Type BLA
Sponsor FRESENIUS KABI USA Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761449 Tyenne tocilizumab-aazg 351(k) Biosimilar Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 004 TYENNE TOCILIZUMAB-AAZG INJECTABLE;SUBCUTANEOUS 162MG/0.9ML 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 TYENNE TOCILIZUMAB-AAZG Fresenius Kabi USA, LLC 87ac5047-4f2b-4571-a8a8-32e08865f379 2026-07-23 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761449
Documents# Document, Submission type, Date table Document Submission type Date 86014 SUPPL 2026-05-22 86009 SUPPL 2026-05-21 86004 SUPPL 2026-05-21 85843 ORIG 2026-05-07 82180 SUPPL 2025-05-14 82250 SUPPL 2025-05-12 81622 ORIG 2025-03-18 81600 ORIG 2025-03-17 81599 ORIG 2025-03-17