Home Applications 022458 Application 022458
Type BLA
Sponsor PFIZER Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 022458 Elelyso taliglucerase alfa 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELELYSO TALIGLUCERASE ALFA POWDER;INTRAVENOUS 200 UNITS/VIAL 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 ELELYSO TALIGLUCERASE ALFA Pfizer Laboratories Div Pfizer Inc fa3cbd5d-677c-4b19-9032-d9182cb69a83 2025-12-29 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA022458 ndc (product): 0069-0106
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 0069-0106 ELELYSO Taliglucerase alfa Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0106 ELELYSO Taliglucerase alfa Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0106 ELELYSO Taliglucerase alfa Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0106 ELELYSO Taliglucerase alfa Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0106 ELELYSO Taliglucerase alfa Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0106 ELELYSO Taliglucerase alfa Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0106 ELELYSO Taliglucerase alfa Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0106 ELELYSO Taliglucerase alfa Pfizer Laboratories Div Pfizer Inc BLA Current