Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| CU Chemie Uetikon GmbH | Lahr, Germany | Makes the active ingredient | Problems found, fixed voluntarilyJan 30, 2025 · 6 inspections |
| Glatt Air Techniques, Inc. | Ramsey, NJ, United States | Makes it | No problems foundApr 13, 2023 · 8 inspections |
| EMSL Analytical, Inc. DBA MPL Laboratories | Sparta, NJ, United States | Tests it | No problems foundJan 12, 2024 · 6 inspections |
| Sharp Clinical Services, LLC | Bethlehem, PA, United States | Packages it | No problems foundAug 29, 2024 · 6 inspections |
Product details
- Generic drug
- Phenylbutyric Acid: every company that makes it
- Form
- kit, oral
- Strength
- 3 g / 3.67 g
- Approval
- NDA NDA214860
- On the market since
- Dec 22, 2022
- Package NDCs
72542-000-0172542-003-0172542-367-0172542-667-0272542-667-18- Official label
- DailyMed (National Library of Medicine), updated Dec 18, 2024
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