FDA.reportPublic FDA data

Application 761261

Type
BLA
Sponsor
GENZYME CORP

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761261Xenpozymeolipudase alfa-rpcp351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XENPOZYMEOLIPUDASE ALFA-RPCPINJECTABLE;INJECTION20MGNoNo

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
XENPOZYMEOLIPUDASE ALFA-RPCPGenzyme Corporation01a910ee-a33e-4be3-ac41-322d64c343112025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761261
ndc (product): 58468-0050

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58468-0050XENPOZYMEolipudase alfa-rpcpGenzyme CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80748SUPPL 2024-12-27
80716SUPPL 2024-12-26
80715SUPPL 2024-12-26
76746SUPPL 2023-12-06
76745SUPPL 2023-12-06
72071ORIG2022-09-13
71994ORIG2022-09-01
71988ORIG2022-09-01