Home Applications 761054 Application 761054
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 761054 Renflexis infliximab-abda 351(k) Biosimilar Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RENFLEXIS INFLIXIMAB-ABDA INJECTABLE;INJECTION 100MG 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-4305 Renflexis infliximab Merck Sharp & Dohme Corp. BLA Current 0006-4305 Renflexis infliximab Merck Sharp & Dohme Corp. BLA Current 0006-4305 Renflexis infliximab Merck Sharp & Dohme Corp. BLA Current 0006-4305 Renflexis infliximab Merck Sharp & Dohme Corp. BLA Current 0006-4305 Renflexis infliximab Merck Sharp & Dohme Corp. BLA Current 0006-4305 Renflexis infliximab Merck Sharp & Dohme Corp. BLA Current 0006-4305 Renflexis infliximab Merck Sharp & Dohme Corp. BLA Current 78206-162 Renflexis infliximab Organon LLC BLA Current 78206-162 Renflexis infliximab Organon LLC BLA Current