FDA.reportPublic FDA data

Application 761052

Type
BLA
Sponsor
BIOMARIN PHARM

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761052Brineuracerliponase alfa351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRINEURACERLIPONASE ALFAINJECTABLE;INJECTION30MG/MLNoNo

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
BrineuraCERLIPONASE ALFABioMarin Pharmaceutical Inc.485ab3c5-0359-4878-872f-2fe1e7df40472024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761052
ndc (product): 68135-811

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
68135-811Brineuracerliponase alfaBioMarin Pharmaceutical Inc.BLACurrent
68135-811Brineuracerliponase alfaBioMarin Pharmaceutical Inc.BLACurrent
68135-811Brineuracerliponase alfaBioMarin Pharmaceutical Inc.BLACurrent
68135-811Brineuracerliponase alfaBioMarin Pharmaceutical Inc.BLACurrent
68135-811Brineuracerliponase alfaBioMarin Pharmaceutical Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79223SUPPL 2024-07-29
79208SUPPL 2024-07-25
79080SUPPL 2024-07-15
79048SUPPL 2024-07-11
62373SUPPL2020-03-31
62359SUPPL2020-03-30
61217SUPPL2019-12-10
61193SUPPL2019-12-09
56844SUPPL2018-12-20
56712SUPPL2018-12-12
48669ORIG2017-06-07
48156ORIG2017-04-28
48155ORIG2017-04-28