Home Applications 761049 Application 761049
Type BLA
Sponsor EMD SERONO INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761049 Bavencio avelumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BAVENCIO AVELUMAB INJECTABLE;INJECTION 20MG/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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 44087-3535 BAVENCIO avelumab EMD Serono, Inc. BLA Current 44087-3535 BAVENCIO avelumab EMD Serono, Inc. BLA Current 44087-3535 BAVENCIO avelumab EMD Serono, Inc. BLA Current 44087-3535 BAVENCIO avelumab EMD Serono, Inc. BLA Current 44087-3535 BAVENCIO avelumab EMD Serono, Inc. BLA Current 44087-3535 BAVENCIO avelumab EMD Serono, Inc. BLA Current 44087-3535 BAVENCIO avelumab EMD Serono, Inc. BLA Current