Home Applications 125557 Application 125557
Type BLA
Sponsor AMGEN Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125557 Blincyto blinatumomab 351(a) Rx 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BLINCYTO BLINATUMOMAB INJECTABLE;INJECTION 35MCG 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55513-160 BLINCYTO blinatumomab Amgen Inc BLA Current 55513-160 BLINCYTO blinatumomab Amgen Inc BLA Current 55513-160 BLINCYTO blinatumomab Amgen Inc BLA Current 55513-160 BLINCYTO blinatumomab Amgen Inc BLA Current 55513-160 BLINCYTO blinatumomab Amgen Inc BLA Current 55513-160 BLINCYTO blinatumomab Amgen Inc BLA Current 55513-160 BLINCYTO blinatumomab Amgen Inc BLA Current 55513-160 BLINCYTO blinatumomab Amgen Inc BLA Current