Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
Product details
- Generic drug
- Mesalamine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 0.375 g
- Approval
- ANDA ANDA214477
- On the market since
- Mar 31, 2023
- Package NDCs
59651-397-08- Official label
- DailyMed (National Library of Medicine), updated Jan 20, 2024
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