Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Bausch Health Companies Inc. | Steinbach, Canada | Makes it | No problems foundMay 19, 2023 · 6 inspections |
| Catalent Pharma Solutions, LLC | Winchester, KY, United States | Makes it | Problems found, fixed voluntarilyApr 22, 2025 · 10 inspections |
Product details
- Generic drug
- Mesalamine: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 375 mg
- Approval
- NDA NDA022301
- On the market since
- Oct 31, 2008
- Package NDCs
65649-103-0165649-103-02- Official label
- DailyMed (National Library of Medicine), updated Oct 22, 2026
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