General MedicationsORALStandard
GALAFOLD
MIGALASTAT HYDROCHLORIDE
Standard Dose
EQ 123MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview GALAFOLD is listed in Drugs@FDA under application 208623 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient MIGALASTAT HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 123MG BASE Sponsor AMICUS THERAP US Submission history Latest submission status date: 2025-03-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview GALAFOLD is listed in Drugs@FDA under application 208623 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MIGALASTAT HYDROCHLORIDE Form and strength CAPSULE;ORAL - EQ 123MG BASE Sponsor AMICUS THERAP US Submission history Latest submission status date: 2025-03-19 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.