Home Applications 020367 Application 020367
Type BLA
Sponsor GENZYME Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 020367 Cerezyme imiglucerase 351(a) Disc 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEREZYME IMIGLUCERASE INJECTABLE;INJECTION 200 UNITS/VIAL No No 002 CEREZYME IMIGLUCERASE INJECTABLE;INJECTION 400 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58468-1983 Cerezyme IMIGLUCERASE Genzyme Corporation NDA Current 58468-1983 Cerezyme IMIGLUCERASE Genzyme Corporation BLA Current 58468-4663 Cerezyme IMIGLUCERASE Genzyme Corporation NDA Current 58468-4663 Cerezyme IMIGLUCERASE Genzyme Corporation BLA Current 58468-4663 Cerezyme IMIGLUCERASE Genzyme Corporation BLA Current 58468-4663 Cerezyme IMIGLUCERASE Genzyme Corporation BLA Current 58468-4663 Cerezyme IMIGLUCERASE Genzyme Corporation BLA Current 58468-4663 Cerezyme IMIGLUCERASE Genzyme Corporation BLA Current 58468-4663 Cerezyme IMIGLUCERASE Genzyme Corporation BLA Current 58468-4663 Cerezyme IMIGLUCERASE Genzyme Corporation BLA Current