Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| CHEMI SpA | Patrica, Italy | Makes the active ingredient and tests it | Problems found, fixed voluntarilyJan 26, 2024 · 6 inspections |
| Italfarmaco S.A. | Alcobendas, Spain | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJul 15, 2021 · 1 inspection |
Product details
- Generic drug
- Givinostat: every company that makes it
- Form
- suspension, oral
- Strength
- 8.86 mg per 1 mL
- Approval
- NDA NDA217865
- On the market since
- Mar 21, 2024
- Package NDCs
11797-110-0111797-110-02- Official label
- DailyMed (National Library of Medicine), updated Nov 21, 2024
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