Home Applications 761340 Application 761340
Type BLA
Sponsor SAMSUNG BIOEPIS CO LTD Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761340 Epysqli eculizumab-aagh 351(k) Interchangeable Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EPYSQLI ECULIZUMAB-AAGH INJECTION;SOLUTION 300 mg/30 mL (10 mg/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 EPYSQLI ECULIZUMAB-AAGH Teva Pharmaceuticals USA, Inc. 1fa1aa80-1c59-44d4-9841-b6c52882651b 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761340