FDA.report

Application 125291

Type
BLA
Sponsor
GENZYME

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001LUMIZYMEALGLUCOSIDASE ALFAPOWDER; IV (INFUSION)5MG/MLNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
58468-0160LumizymeALGLUCOSIDASE ALFAGenzyme CorporationBLACurrent
58468-0160LumizymeALGLUCOSIDASE ALFAGenzyme CorporationBLACurrent
58468-0160LumizymeALGLUCOSIDASE ALFAGenzyme CorporationBLACurrent
58468-0160LumizymeALGLUCOSIDASE ALFAGenzyme CorporationBLACurrent
58468-0160LumizymeALGLUCOSIDASE ALFAGenzyme CorporationBLACurrent
58468-0160LumizymeALGLUCOSIDASE ALFAGenzyme CorporationBLACurrent
58468-0160LumizymeALGLUCOSIDASE ALFAGenzyme CorporationBLACurrent

Documents

DocumentSubmission typeDate
80797SUPPL 2025-01-02
80791SUPPL 2025-01-02
77963SUPPL 2024-03-25
77962SUPPL 2024-03-25
74380SUPPL 2023-05-26
74368SUPPL 2023-05-25
71079SUPPL2022-05-16
71077SUPPL2022-05-16
71066SUPPL2022-05-13
71065SUPPL2022-05-13
61918SUPPL2020-02-19
61915SUPPL2020-02-19
58955SUPPL2019-06-04
58908SUPPL2019-05-31
22800SUPPL2016-07-29
39910SUPPL2014-08-04
31912SUPPL2014-08-04
18855SUPPL2014-05-28
9688SUPPL2014-05-27
31911SUPPL2012-07-18
39909SUPPL2012-07-13
31910SUPPL2012-07-13
24361ORIG2010-07-13
22799ORIG2010-07-13
9687ORIG2010-05-27
18854ORIG2010-05-26