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 100MG · TabletNDA022181-001 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderNDA205065-001 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · PowderThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA205065.
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
- Kuvan
- Active substance
- sapropterin dihydrochloride
- Route
- Oral
- Dosage form
- Powder
- Applicant
- Biomarin Pharm
- Status
- Prescription
- FDA approval
- 19 Dec 2013
- Application
- NDA205065-002