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 2026-08-01
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# 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 · 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