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 2026-06-01
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# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 2026-07-17 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