Sapropterin dihydrochloride
These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE POWDER FOR ORAL SOLUTION. SAPROPTERIN DIHYDROCHLORIDE powder for oral solution Initial U.S. Approval: 2007
Approved
Approval ID
b3999f74-920d-4444-afa7-f4211e4eb431
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sapropterin dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-194
Application NumberANDA215420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sapropterin dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (5)
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POTASSIUM CITRATEInactive
Code: EE90ONI6FF
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SAPROPTERIN DIHYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: RG277LF5B3
Classification: ACTIB
Sapropterin dihydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-193
Application NumberANDA215420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sapropterin dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
POTASSIUM CITRATEInactive
Code: EE90ONI6FF
Classification: IACT
SAPROPTERIN DIHYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: RG277LF5B3
Classification: ACTIB