Home Applications 761164 Application 761164
Type BLA
Sponsor BIOVERATIV THERAPEUTICS INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761164 Enjaymo sutimlimab-jome 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENJAYMO SUTIMLIMAB-JOME INJECTABLE;INJECTION 1,100MG/22ML(50MG/ML) 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Enjaymo SUTIMLIMAB-JOME Recordati Rare Diseases, Inc. 0a25363a-7781-d9f8-cb1c-be22987bf03b 2026-03-02 Warnings, Adverse reactions Exact identifier application number: BLA761164
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 80203-347 Enjaymo sutimlimab Bioverativ U.S. LLC. BLA Current 80203-347 Enjaymo sutimlimab-jome Bioverativ U.S. LLC. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 77437 SUPPL 2024-02-09 77436 SUPPL 2024-02-09 77435 SUPPL 2024-02-09 73298 SUPPL 2023-01-26 73297 SUPPL 2023-01-26 73296 SUPPL 2023-01-26 72426 SUPPL 2022-10-20 70401 ORIG 2022-03-04 70193 ORIG 2022-02-18 70095 ORIG 2022-02-04 70094 ORIG 2022-02-04