FDA.reportPublic FDA data

Application 761195

Type
BLA
Sponsor
ARGENX BV

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761195Vyvgartefgartigimod alfa-fcab351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VYVGARTEFGARTIGIMOD ALFAINJECTABLE;INJECTION400MGNoNo

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VYVGARTEFGARTIGIMOD ALFAargenx US8aefc8e3-26d6-4ff6-aab9-a7542927e0842026-05-13Warnings, Adverse reactionsExact identifier
application number: BLA761195
ndc (product): 73475-3041

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
73475-3041VYVGARTEFGARTIGIMOD ALFAargenx USBLACurrent
73475-3041VYVGARTEFGARTIGIMOD ALFAargenx USBLACurrent
73475-3041VYVGARTEFGARTIGIMOD ALFAargenx USBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85944SUPPL 2026-05-18
85874SUPPL 2026-05-11
83861SUPPL 2025-10-21
83826SUPPL 2025-10-20
79364SUPPL 2024-08-12
79358SUPPL 2024-08-09
79227SUPPL 2024-07-29
79206SUPPL 2024-07-25
76785SUPPL 2023-12-13
76779SUPPL 2023-12-13
69909ORIG2022-01-19
69723ORIG2021-12-21
69636ORIG2021-12-19