Home Applications 125291 Application 125291
Type BLA
Sponsor GENZYME Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125291 Lumizyme alglucosidase alfa 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LUMIZYME ALGLUCOSIDASE ALFA POWDER; IV (INFUSION) 5MG/ML 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 58468-0160 Lumizyme ALGLUCOSIDASE ALFA Genzyme Corporation BLA Current 58468-0160 Lumizyme ALGLUCOSIDASE ALFA Genzyme Corporation BLA Current 58468-0160 Lumizyme ALGLUCOSIDASE ALFA Genzyme Corporation BLA Current 58468-0160 Lumizyme ALGLUCOSIDASE ALFA Genzyme Corporation BLA Current 58468-0160 Lumizyme ALGLUCOSIDASE ALFA Genzyme Corporation BLA Current 58468-0160 Lumizyme ALGLUCOSIDASE ALFA Genzyme Corporation BLA Current 58468-0160 Lumizyme ALGLUCOSIDASE ALFA Genzyme Corporation BLA Current