Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Latina Pharma S.P.A | Sermoneta, Italy | Makes it | Problems found, fixed voluntarilyJan 19, 2024 · 5 inspections, 1 with FDA action |
Product details
- Generic drug
- Hydroxyurea: every company that makes it
- Form
- capsule, oral
- Strength
- 300 mg
- Approval
- NDA NDA016295
- On the market since
- Sep 11, 2025
- Package NDCs
80725-830-60- Official label
- DailyMed (National Library of Medicine), updated Sep 12, 2025
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