Fintepla
These highlights do not include all the information needed to use FINTEPLA safely and effectively. See full prescribing information for FINTEPLA. FINTEPLA (fenfluramine) oral solution Initial U.S. Approval: 1973
Approved
Approval ID
e88f360e-33ad-4cd6-b2de-5ef885857c5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
UCB, Inc.
DUNS: 028526403
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fenfluramine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43376-322
Application NumberNDA212102
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenfluramine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (8)
waterInactive
Code: 059QF0KO0R
Classification: IACT
potassium citrateInactive
Code: EE90ONI6FF
Classification: IACT
hydroxyethyl cellulose (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
sucraloseInactive
Code: 96K6UQ3ZD4
Classification: IACT
fenfluramineActive
Quantity: 2.2 mg in 1 mL
Code: 2DS058H2CF
Classification: ACTIB
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
ethylparabenInactive
Code: 14255EXE39
Classification: IACT