Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Encube Ethicals Limited | Ponda, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJun 17, 2024 · 4 inspections |
Product details
- Generic drug
- Mesalamine: every company that makes it
- Form
- suspension, rectal
- Strength
- 4 g per 60 mL
- Approval
- ANDA ANDA216941
- On the market since
- Jun 1, 2023
- Package NDCs
21922-045-0121922-045-4721922-045-49- Official label
- DailyMed (National Library of Medicine), updated Oct 7, 2025
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