← FDA Drug Approvals (Drugs@FDA)
WAKIX
NDA · New Drug Application · Sponsor: HARMONY · Approved 2020-10-13
Drug application
- FDA Application #
NDA211150- Application type
- New Drug Application
- Brand name
- WAKIX
- Generic name
- PITOLISANT HYDROCHLORIDE
- Active ingredients
- PITOLISANT HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HARMONY
- Manufacturer
- Harmony Biosciences, LLC
- First approval
- 2020-10-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown