FDA.reportPublic FDA data

Application 103979

Type
BLA
Sponsor
GENZYME

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103979Fabrazymeagalsidase beta351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FABRAZYMEAGALSIDASE BETAVIAL; INTRAVENOUS5MG/VIALNoNo
002FABRAZYMEAGALSIDASE BETAVIAL; INTRAVENOUS35MG/VIALNoNo

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FabrazymeAGALSIDASE BETAGenzyme Corporation988513ab-b06f-4dd0-93f7-d2d4531dcce42025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103979
ndc (product): 58468-0040
ndc (product): 58468-0041

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58468-0040FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent
58468-0040FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent
58468-0040FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent
58468-0040FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent
58468-0040FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent
58468-0041FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent
58468-0041FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent
58468-0041FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent
58468-0041FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent
58468-0041FabrazymeAGALSIDASE BETAGenzyme CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79077SUPPL 2024-07-15
79044SUPPL 2024-07-11
77416SUPPL 2024-02-07
77414SUPPL 2024-02-07
74649SUPPL 2023-06-29
66769SUPPL2021-03-12
66760SUPPL2021-03-12
60774SUPPL2019-11-04
56934SUPPL2018-12-21
56789SUPPL2018-12-19
39775SUPPL2011-01-05
18727SUPPL2009-01-16
31760SUPPL2008-12-29
39774SUPPL2007-01-08
18726SUPPL2007-01-08
18725SUPPL2007-01-08
9535SUPPL2007-01-08
9534SUPPL2007-01-08
9533SUPPL2007-01-08
22767ORIG2004-03-15
18724ORIG2004-03-15
9532ORIG2004-03-15