← FDA Drug Approvals (Drugs@FDA)
OPFOLDA
NDA · New Drug Application · Sponsor: AMICUS THERAP US · Approved 2023-09-28
Drug application
- FDA Application #
NDA215211- Application type
- New Drug Application
- Brand name
- OPFOLDA
- Generic name
- MIGLUSTAT
- Active ingredients
- MIGLUSTAT
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AMICUS THERAP US
- Manufacturer
- AMICUS THERAPEUTICS US, LLC
- First approval
- 2023-09-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown