FDA.reportPublic FDA data

Application 125058

Type
BLA
Sponsor
BIOMARIN

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125058Aldurazymelaronidase351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALDURAZYMELARONIDASEVIAL2.9MG/MLNoNo

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 ยท 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58468-0070ALDURAZYMElaronidaseGenzyme CorporationBLACurrent
58468-0070ALDURAZYMElaronidaseGenzyme CorporationBLACurrent
58468-0070ALDURAZYMElaronidaseGenzyme CorporationBLACurrent
58468-0070ALDURAZYMElaronidaseGenzyme CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76854SUPPL 2023-12-15
76845SUPPL 2023-12-15
61176SUPPL2019-12-06
61158SUPPL2019-12-05
18762SUPPL2013-04-09
9580SUPPL2013-04-09
18761SUPPL2011-01-03
39812SUPPL2009-06-29
18760SUPPL2009-06-29
31797SUPPL2009-06-10
9579SUPPL2009-06-10
9578SUPPL2008-05-28
43301ORIG2004-03-10
18759ORIG2004-03-10
9577ORIG2004-03-10