Home Applications 761304 Application 761304
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 761304 Vyvgart Hytrulo efgartigimod alfa and hyaluronidase-qvfc 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VYVGART HYTRULO EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC INJECTABLE;INJECTION 1008MG;11200UNITS PER 5.6ML No No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VYVGART Hytrulo EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT) argenx US 7104d9e5-9910-47f5-9a93-741ac50f43b6 2026-07-15 Warnings, Adverse reactions Exact identifier application number: BLA761304