NDC 31722-048
Sapropterin dihydrochloride 500 mg powder, for solution
On the label: Camber Pharmaceuticals Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Annora Pharma Private Limited | Sangareddy, India | Makes it and tests it | Problems found, fixed voluntarilyMar 28, 2025 · 4 inspections |
Product details
- Generic drug
- Sapropterin: every company that makes it
- Form
- powder, for solution, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA215420
- On the market since
- Aug 18, 2022
- Package NDCs
31722-048-0131722-048-3031722-048-31- Official label
- DailyMed (National Library of Medicine), updated Mar 5, 2026
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