FDA.reportPublic FDA data

Application 761047

Type
BLA
Sponsor
ULTRAGENYX PHARM INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761047Mepseviivestronidase alfa-vjbk351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEPSEVIIVESTRONIDASE ALFA-VJBKINJECTABLE;INJECTION10MG/5MLNoNo

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
MEPSEVIIVESTRONIDASE ALFAUltragenyx Pharmaceutical Inc.925d4e21-fd98-474d-a34d-a0b3558ed7502025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761047
ndc (product): 69794-001

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69794-001MEPSEVIIvestronidase alfaUltragenyx Pharmaceutical Inc.BLACurrent
69794-001MEPSEVIIvestronidase alfaUltragenyx Pharmaceutical Inc.BLACurrent
69794-001MEPSEVIIvestronidase alfaUltragenyx Pharmaceutical Inc.BLACurrent
69794-001MEPSEVIIvestronidase alfaUltragenyx Pharmaceutical Inc.BLACurrent
69794-001MEPSEVIIvestronidase alfaUltragenyx Pharmaceutical Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65769SUPPL2020-12-28
65760SUPPL2020-12-28
61216SUPPL2019-12-10
61192SUPPL2019-12-09
50930ORIG2017-12-27
50521ORIG2017-11-29
50419ORIG2017-11-15