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
262503e7-de09-4b42-9963-ec00cbc7c35c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2019
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 Code13267-345
Application NumberNDA200655
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluorodopa F18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 16, 2019
FDA Product Classification
INGREDIENTS (1)
FLUORODOPA F-18Active
Quantity: 8.33 mCi in 1 mL
Code: 2C598205QX
Classification: ACTIB