← FDA Drug Approvals (Drugs@FDA)
GALAFOLD
NDA · New Drug Application · Sponsor: AMICUS THERAP US · Approved 2018-08-10
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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