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 2026-08-01
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# 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 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