# WAKIX
> **NDA211150** · New Drug Application · Sponsor: HARMONY · Approved 2020-10-13
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211150)
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