Home Applications 103979 Application 103979
Type BLA
Sponsor GENZYME Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103979 Fabrazyme agalsidase beta 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FABRAZYME AGALSIDASE BETA VIAL; INTRAVENOUS 5MG/VIAL No No 002 FABRAZYME AGALSIDASE BETA VIAL; INTRAVENOUS 35MG/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 58468-0040 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current 58468-0040 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current 58468-0040 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current 58468-0040 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current 58468-0040 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current 58468-0041 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current 58468-0041 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current 58468-0041 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current 58468-0041 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current 58468-0041 Fabrazyme AGALSIDASE BETA Genzyme Corporation BLA Current