Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Havix Group Inc d/b/a Aavis Pharmaceuticals | Hoschton, GA, United States | Makes it | Problems found, fixed voluntarilyJul 25, 2025 · 2 inspections |
Product details
- Generic drug
- Roflumilast: every company that makes it
- Form
- tablet, oral
- Strength
- 500 ug
- Approval
- ANDA ANDA208236
- On the market since
- Feb 2, 2026
- Package NDCs
59746-802-0559746-802-3059746-802-90- Official label
- DailyMed (National Library of Medicine), updated Jul 14, 2026
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