NDC 31722-044
Zileuton 600 mg tablet, film coated, extended release
On the label: Camber Pharmaceuticals Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Annora Pharma Private Limited | Sangareddy, India | Makes it | Problems found, fixed voluntarilyMar 28, 2025 · 4 inspections |
Product details
- Generic drug
- Zileuton: every company that makes it
- Form
- tablet, film coated, extended release, oral
- Strength
- 600 mg
- Approval
- ANDA ANDA215742
- On the market since
- Oct 11, 2022
- Package NDCs
31722-044-12- Official label
- DailyMed (National Library of Medicine), updated Oct 14, 2022
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