FDA
Sapropterin Dihydrochloride
The FDA lists this product in 15 strengths and forms.
Composition
- Active ingredients
- SAPROPTERIN DIHYDROCHLORIDE 100MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA207207-001 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 100MG · TabletANDA215534-001 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · PowderANDA216432-002 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA216432-001 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA219511-001 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · PowderANDA219511-002 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 100MG · TabletThis page
- SAPROPTERIN DIHYDROCHLORIDE 100MG · TabletANDA207200-001 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA209452-001 · Prescription
- SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · PowderANDA215420-001 · Prescription
At a glance
- Brand name
- Sapropterin Dihydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Zenara
- Status
- Prescription
- FDA approval
- 11 Jun 2025
- Application
- ANDA218797-001