Home Applications 125460 Application 125460
Type BLA
Sponsor BIOMARIN PHARM Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125460 Vimizim elosulfase alfa 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VIMIZIM ELOSULFASE ALFA 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VIMIZIM ELOSULFASE ALFA BioMarin Pharmaceutical Inc. 0caa2565-12b2-0ad0-1f9a-273e81c3d4cc 2025-10-30 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125460 ndc (product): 68135-100
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 68135-100 VIMIZIM elosulfase alfa BioMarin Pharmaceutical Inc. BLA Current 68135-100 VIMIZIM elosulfase alfa BioMarin Pharmaceutical Inc. BLA Current 68135-100 VIMIZIM elosulfase alfa BioMarin Pharmaceutical Inc. BLA Current 68135-100 VIMIZIM elosulfase alfa BioMarin Pharmaceutical Inc. BLA Current 68135-100 VIMIZIM elosulfase alfa BioMarin Pharmaceutical Inc. BLA Current 68135-100 VIMIZIM elosulfase alfa BioMarin Pharmaceutical Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 84034 SUPPL 2025-11-03 84031 SUPPL 2025-10-31 61175 SUPPL 2019-12-06 61157 SUPPL 2019-12-04 44808 ORIG 2014-03-24 22811 ORIG 2014-03-24 39972 ORIG 2014-02-19 9760 ORIG 2014-02-19