Home Applications 125249 Application 125249
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 125249 Arcalyst rilonacept 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ARCALYST RILONACEPT VIAL; SINGLE-USE 220MG 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 61755-001 Arcalyst rilonacept Regeneron Pharmaceuticals, Inc. BLA Current 61755-001 Arcalyst rilonacept Regeneron Pharmaceuticals, Inc. BLA Current 61755-001 Arcalyst rilonacept Regeneron Pharmaceuticals, Inc. BLA Current 61755-001 Arcalyst rilonacept Regeneron Pharmaceuticals, Inc. BLA Current 61755-001 Arcalyst rilonacept Regeneron Pharmaceuticals, Inc. BLA Current 73604-914 Arcalyst rilonacept Kiniksa Pharmaceuticals (UK), Ltd. BLA Current 73604-914 Arcalyst rilonacept Kiniksa Pharmaceuticals (UK), Ltd. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 85335 SUPPL 2026-03-12 85334 SUPPL 2026-03-12 81541 SUPPL 2025-03-12 66823 SUPPL 2021-03-22 66812 SUPPL 2021-03-19 65672 SUPPL 2020-12-22 65628 SUPPL 2020-12-21 64097 SUPPL 2020-07-27 64090 SUPPL 2020-07-24 43311 ORIG 2008-05-02 31869 ORIG 2008-04-09 39876 ORIG 2008-03-11