# SIKLOS
> **NDA208843** · New Drug Application · Sponsor: THERAVIA · Approved 2017-12-21
## Drug
- **FDA Application Number:** NDA208843
- **Application type:** New Drug Application
- **Brand name:** SIKLOS
- **Generic name:** HYDROXYUREA
- **Active ingredients:** HYDROXYUREA
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** THERAVIA
- **Manufacturer:** Medunik
- **First approval:** 2017-12-21
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208843)
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*MORVS · CC0 1.0*