Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Micro Labs Limited | Verna, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMay 30, 2025 · 6 inspections, 1 with FDA action |
Product details
- Generic drug
- Roflumilast: every company that makes it
- Form
- tablet, oral
- Strength
- 500 ug
- Approval
- ANDA ANDA208180
- On the market since
- Oct 19, 2022
- Package NDCs
42571-259-0542571-259-1742571-259-3042571-259-3242571-259-90- Official label
- DailyMed (National Library of Medicine), updated Jul 24, 2025
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