Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Product details
- Generic drug
- Phenylbutyric Acid: every company that makes it
- Form
- tablet, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA216462
- On the market since
- Nov 1, 2022
- Package NDCs
68462-853-20- Official label
- DailyMed (National Library of Medicine), updated Jan 28, 2026
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