Sapropterin Dihydrochloride
for oral solution. Initial U.S. Approval: 2007
Approved
Approval ID
9a8d9361-d600-4d11-33c1-e0ecd56aaf2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2020
Manufacturers
FDA
Dr. Reddys Laboratories Inc
DUNS: 802315887
Products 1
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 Code43598-477
Application NumberANDA209452
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sapropterin Dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2020
FDA Product Classification
INGREDIENTS (5)
Sapropterin DihydrochlorideActive
Quantity: 100 mg in 1 1
Code: RG277LF5B3
Classification: ACTIB
SucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
Potassium CitrateInactive
Code: EE90ONI6FF
Classification: IACT
Ascorbic AcidInactive
Code: PQ6CK8PD0R
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT