# HARLIKU
> **NDA209449** · New Drug Application · Sponsor: CYCLE · Approved 2017-07-26
## Drug
- **FDA Application Number:** NDA209449
- **Application type:** New Drug Application
- **Brand name:** HARLIKU
- **Generic name:** NITISINONE
- **Active ingredients:** NITISINONE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** CYCLE
- **Manufacturer:** Cycle Pharmaceuticals Ltd.
- **First approval:** 2017-07-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209449)
---
*MORVS · CC0 1.0*