Home Applications 761195 Application 761195
Type BLA
Sponsor ARGENX BV Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761195 Vyvgart efgartigimod alfa-fcab 351(a) Rx 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VYVGART EFGARTIGIMOD ALFA INJECTABLE;INJECTION 400MG 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73475-3041 VYVGART EFGARTIGIMOD ALFA argenx US BLA Current 73475-3041 VYVGART EFGARTIGIMOD ALFA argenx US BLA Current 73475-3041 VYVGART EFGARTIGIMOD ALFA argenx US BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 85944 SUPPL 2026-05-18 85874 SUPPL 2026-05-11 83861 SUPPL 2025-10-21 83826 SUPPL 2025-10-20 79364 SUPPL 2024-08-12 79358 SUPPL 2024-08-09 79227 SUPPL 2024-07-29 79206 SUPPL 2024-07-25 76785 SUPPL 2023-12-13 76779 SUPPL 2023-12-13 69909 ORIG 2022-01-19 69723 ORIG 2021-12-21 69636 ORIG 2021-12-19