FDA.reportPublic FDA data

Application 103979

Type
BLA
Sponsor
GENZYME

Application Products#

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

NDC Listings For This Application#

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