Home Applications 761498 Application 761498
Type BLA
Sponsor CELLTRION INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761498 Avtozma tocilizumab-anoh 351(k) Interchangeable Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AVTOZMA TOCILIZUMAB-ANOH INJECTABLE;IV (INFUSION) 80MG/4ML(20MG/ML) No No 002 AVTOZMA TOCILIZUMAB-ANOH INJECTABLE;IV (INFUSION) 200MG/10ML(20MG/ML) No No 003 AVTOZMA TOCILIZUMAB-ANOH INJECTABLE;IV (INFUSION) 400MG/20ML(20MG/ML) No No 004 AVTOZMA TOCILIZUMAB-ANOH INJECTABLE;SUBCUTANEOUS 162MG/20ML(20MG/ML) No No
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Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AVTOZMA TOCILIZUMAB CELLTRION USA, Inc. 581c288f-8015-40ef-a4c3-683c96db193d 2026-07-27 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761498
Documents# Document, Submission type, Date table Document Submission type Date 85025 ORIG 2026-02-12 84818 ORIG 2026-01-22 84793 ORIG 2026-01-21 84792 ORIG 2026-01-21