FDA.reportPublic FDA data

Application 761204

Type
BLA
Sponsor
AMICUS THERAP US

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761204Pombiliticipaglucosidase alfa-atga351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POMBILITICIPAGLUCOSIDASE ALFA-ATGAINJECTABLE;INJECTION105MGNoNo

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POMBILITI ATGACIPAGLUCOSIDASE ALFA-ATGAAMICUS THERAPEUTICS US, LLCd77aa596-910d-516b-e053-2995a90a08392026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761204

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79238SUPPL 2024-07-29
79216SUPPL 2024-07-26
75991ORIG 2023-10-31
75618ORIG 2023-10-30
75603ORIG 2023-09-29