SAPROPTERIN DIHYDROCHLORIDE
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . for oral solution Initial U.S. Approval:
Approved
Approval ID
6b2172e4-42fc-42fe-b1ad-9d6a974d4343
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2020
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code49884-948
Application NumberANDA207207
Product Classification
M
Marketing Category
C73584
G
Generic Name
SAPROPTERIN DIHYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 14, 2020
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SAPROPTERIN DIHYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: RG277LF5B3
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
POTASSIUM CITRATEInactive
Code: EE90ONI6FF
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT