Home Applications 761204 Application 761204
Type BLA
Sponsor AMICUS THERAP US Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761204 Pombiliti cipaglucosidase alfa-atga 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POMBILITI CIPAGLUCOSIDASE ALFA-ATGA INJECTABLE;INJECTION 105MG No No
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join POMBILITI ATGA CIPAGLUCOSIDASE ALFA-ATGA AMICUS THERAPEUTICS US, LLC d77aa596-910d-516b-e053-2995a90a0839 2026-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761204
Documents# Document, Submission type, Date table Document Submission type Date 79238 SUPPL 2024-07-29 79216 SUPPL 2024-07-26 75991 ORIG 2023-10-31 75618 ORIG 2023-10-30 75603 ORIG 2023-09-29