Home Applications 761055 Application 761055
Type BLA
Sponsor REGENERON PHARMACEUTICALS Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761055 Dupixent dupilumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DUPIXENT DUPILUMAB INJECTABLE; INJECTION 150MG/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 2 · 91 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5911 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5914 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5915 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5916 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5918 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current 0024-5919 Dupixent Dupilumab sanofi-aventis U.S. LLC BLA Current