Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sanofi Winthrop Industrie | Ambares Et Lagrave, France | Makes it and tests it | Problems found, fixed voluntarilyNov 22, 2023 · 5 inspections |
| Sanofi Winthrop Industrie | Sisteron, France | Makes the active ingredient and tests it | Problems found, fixed voluntarilySep 15, 2023 · 6 inspections |
| Genzyme Corporation | Northborough, MA, United States | Packages it and labels it | No problems foundAug 14, 2025 · 6 inspections |
| Sanofi Winthrop Industrie | Tours, France | Packages it and labels it | Problems found, fixed voluntarilyJan 27, 2023 · 6 inspections |
Product details
- Generic drug
- Dronedarone: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 400 mg
- Approval
- NDA NDA022425
- On the market since
- Jul 1, 2009
- Package NDCs
0024-4142-000024-4142-060024-4142-100024-4142-500024-4142-60- Official label
- DailyMed (National Library of Medicine), updated May 29, 2025
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