sapropterin dihydrochloride
These highlights do not include all the information needed to use SAPROPTERIN DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SAPROPTERIN DIHYDROCHLORIDE TABLETS. SAPROPTERIN DIHYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2007
Approved
Approval ID
a64a50ba-e3da-4227-9bce-87101d60409e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
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 Code72603-191
Application NumberANDA215534
Product Classification
M
Marketing Category
C73584
G
Generic Name
sapropterin dihydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RIBOFLAVINInactive
Code: TLM2976OFR
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SAPROPTERIN DIHYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: RG277LF5B3
Classification: ACTIB