FDA.reportPublic FDA data

Application 125141

Type
BLA
Sponsor
GENZYME

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125141Myozymealglucosidase alfa351(a)Disc2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYOZYMEALGLUCOSIDASE ALFAINJECTABLE; IV (INFUSION)20MG/KGNoNo

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LumizymeALGLUCOSIDASE ALFAGenzyme Corporationd6bfbc45-2d34-439e-8aad-59ee2d53d4df2025-01-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ALGLUCOSIDASE ALFA

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61917SUPPL2020-02-19
61914SUPPL2020-02-19
58954SUPPL2019-06-04
58909SUPPL2019-05-31
18799SUPPL2014-05-28
31843SUPPL2014-05-22
39853SUPPL2012-07-13
31842SUPPL2012-07-13
18798SUPPL2009-01-16
31841SUPPL2008-12-24
22788ORIG2006-06-21
9617ORIG2006-05-02
18797ORIG2006-04-28