Home Applications 761143 Application 761143
Type BLA
Sponsor HORIZON THERAPEUTICS IRELAND Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761143 Tepezza teprotumumab-trbw 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TEPEZZA TEPROTUMUMAB-TRBW INJECTABLE;INJECTION 500MG Yes 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 75987-130 TEPEZZA teprotumumab Horizon Therapeutics USA, Inc. BLA Current 75987-130 TEPEZZA teprotumumab Horizon Therapeutics USA, Inc. BLA Current 75987-130 TEPEZZA teprotumumab Horizon Therapeutics USA, Inc. BLA Current 75987-130 TEPEZZA teprotumumab Horizon Therapeutics USA, Inc. BLA Current 75987-130 TEPEZZA teprotumumab Horizon Therapeutics USA, Inc. BLA Current