# HYDROXYUREA
> **ANDA218021** · Abbreviated New Drug Application (Generic) · Sponsor: QILU · Approved 2024-03-06
## Drug
- **FDA Application Number:** ANDA218021
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** HYDROXYUREA
- **Generic name:** HYDROXYUREA
- **Active ingredients:** HYDROXYUREA
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** QILU
- **Manufacturer:** Somerset Therapeutics, LLC
- **First approval:** 2024-03-06
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218021)
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