Fluorodopa
These highlights do not include all the information needed to use FLUORODOPA F 18 Injection safely and effectively. See full prescribing information for FLUORODOPA F 18 Injection. FLUORODOPA F 18 Injection, for intravenous useInitial U.S. Approval: 2019
Approved
Approval ID
37f8c405-ccb6-4fcd-8513-108956bb1674
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2021
Manufacturers
FDA
THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
DUNS: 110565913
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluorodopa F18
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13267-346
Application NumberNDA200655
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluorodopa F18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 15, 2021
FDA Product Classification
INGREDIENTS (4)
EDETATE DISODIUMInactive
Quantity: 1.46 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
FLUORODOPA F-18Active
Quantity: 40 mCi in 1 mL
Code: 2C598205QX
Classification: ACTIB
ASCORBIC ACIDInactive
Quantity: 5 mg in 1 mL
Code: PQ6CK8PD0R
Classification: IACT
ALCOHOLInactive
Quantity: 23.68 mg in 1 mL
Code: 3K9958V90M
Classification: IACT