Composition
- Active ingredients
- SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · PowderThis page
- SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA218645-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA218645.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Zelvysia
- Active substance
- sapropterin dihydrochloride
- Route
- Oral
- Dosage form
- Powder
- Applicant
- Aucta
- Status
- Prescription
- FDA approval
- 29 Apr 2025
- Application
- ANDA218645-002