# GALAFOLD
> **NDA208623** · New Drug Application · Sponsor: AMICUS THERAP US · Approved 2018-08-10
## Drug
- **FDA Application Number:** NDA208623
- **Application type:** New Drug Application
- **Brand name:** GALAFOLD
- **Generic name:** MIGALASTAT HYDROCHLORIDE
- **Active ingredients:** MIGALASTAT HYDROCHLORIDE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AMICUS THERAP US
- **Manufacturer:** Amicus Therapeutics US, LLC
- **First approval:** 2018-08-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208623)
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