Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Hyderabad, India | Makes it | Problems found, fixed voluntarilyJul 21, 2023 · 8 inspections |
Product details
- Generic drug
- Roflumilast: every company that makes it
- Form
- tablet, oral
- Strength
- 500 ug
- Approval
- ANDA ANDA208213
- On the market since
- Oct 15, 2022
- Package NDCs
31722-623-3031722-623-3131722-623-3231722-623-90- Official label
- DailyMed (National Library of Medicine), updated Apr 28, 2023
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