Home Applications 125058 Application 125058
Type BLA
Sponsor BIOMARIN Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125058 Aldurazyme laronidase 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALDURAZYME LARONIDASE VIAL 2.9MG/ML 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58468-0070 ALDURAZYME laronidase Genzyme Corporation BLA Current 58468-0070 ALDURAZYME laronidase Genzyme Corporation BLA Current 58468-0070 ALDURAZYME laronidase Genzyme Corporation BLA Current 58468-0070 ALDURAZYME laronidase Genzyme Corporation BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 76854 SUPPL 2023-12-15 76845 SUPPL 2023-12-15 61176 SUPPL 2019-12-06 61158 SUPPL 2019-12-05 18762 SUPPL 2013-04-09 9580 SUPPL 2013-04-09 18761 SUPPL 2011-01-03 39812 SUPPL 2009-06-29 18760 SUPPL 2009-06-29 31797 SUPPL 2009-06-10 9579 SUPPL 2009-06-10 9578 SUPPL 2008-05-28 43301 ORIG 2004-03-10 18759 ORIG 2004-03-10 9577 ORIG 2004-03-10