Home Applications 125117 Application 125117
Type BLA
Sponsor BIOMARIN Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125117 Naglazyme galsulfase 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NAGLAZYME GALSULFASE INJECTABLE; INJECTION 5MG/5ML 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68135-020 NAGLAZYME galsulfase BioMarin Pharmaceutical Inc. BLA Current 68135-020 NAGLAZYME galsulfase BioMarin Pharmaceutical Inc. BLA Current 68135-020 NAGLAZYME galsulfase BioMarin Pharmaceutical Inc. BLA Current 68135-020 NAGLAZYME galsulfase BioMarin Pharmaceutical Inc. BLA Current 68135-020 NAGLAZYME galsulfase BioMarin Pharmaceutical Inc. BLA Current 68135-020 NAGLAZYME galsulfase BioMarin Pharmaceutical Inc. BLA Current