Home Applications 125509 Application 125509
Type BLA
Sponsor ELUSYS THERAPEUTICS INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125509 Anthim obiltoxaximab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ANTHIM OBILTOXAXIMAB INJECTABLE;INJECTION 600MG/6ML 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anthim OBILTOXAXIMAB Elusys Therapeutics, Inc. 39ad8799-00a4-4fc8-9852-c0536350c474 2025-11-17 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125509 ndc (product): 69604-204
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69604-204 Anthim obiltoxaximab Elusys Therapeutics, Inc. BLA Current 69604-204 Anthim obiltoxaximab Elusys Therapeutics, Inc. BLA Current 69604-204 Anthim obiltoxaximab Elusys Therapeutics, Inc. BLA Current 69604-204 Anthim obiltoxaximab Elusys Therapeutics, Inc. BLA Current 69604-204 Anthim obiltoxaximab Elusys Therapeutics, Inc. BLA Current