# XROMI
> **NDA216593** · New Drug Application · Sponsor: NOVA LABS LTD · Approved 2024-04-04
## Drug
- **FDA Application Number:** NDA216593
- **Application type:** New Drug Application
- **Brand name:** XROMI
- **Generic name:** HYDROXYUREA
- **Active ingredients:** HYDROXYUREA
- **Dosage form:** SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** NOVA LABS LTD
- **Manufacturer:** Nova Laboratories, Ltd.
- **First approval:** 2024-04-04
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216593)
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