approval · primary record
HYDROXYUREA
2 approval events · latest 2025-01-22
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2025-01-22 |
| Approval events | 2 |
| Brand | SIKLOS |
| Sponsor | THERAVIA |
| Route | ORAL |
Approval history
2 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2025-01-22 | FDA | NDA | SIKLOS | THERAVIA | ORAL |
| 2024-12-23 | FDA | NDA | XROMI | NOVA LABS LTD | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:27:45.579Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:hydroxyurea
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Hydroxyurea · compound