Home Applications 761142 Application 761142
Type BLA
Sponsor VIELA BIO Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761142 Uplizna inebilizumab-cdon 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 UPLIZNA INEBILIZUMAB INJECTABLE;INJECTION 100MG/10ML 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72677-551 UPLIZNA Inebilizumab Viela Bio, Inc. BLA Current 72677-551 UPLIZNA Inebilizumab Viela Bio, Inc. BLA Current 72677-551 UPLIZNA Inebilizumab Viela Bio, Inc. BLA Current 72677-551 UPLIZNA Inebilizumab Viela Bio, Inc. BLA Current 72677-551 UPLIZNA Inebilizumab Viela Bio, Inc. BLA Current 75987-150 UPLIZNA Inebilizumab Horizon Therapeutics USA, Inc. BLA Current 75987-150 UPLIZNA Inebilizumab Horizon Therapeutics USA, Inc. BLA Current 75987-150 UPLIZNA Inebilizumab Horizon Therapeutics USA, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 84445 SUPPL 2025-12-18 84399 SUPPL 2025-12-12 81878 SUPPL 2025-04-08 81825 SUPPL 2025-04-03 81824 SUPPL 2025-04-03 63793 ORIG 2020-07-06 63505 ORIG 2020-06-12 63503 ORIG 2020-06-12 63495 ORIG 2020-06-12