Choline C 11
These highlights do not include all the information needed to use CHOLINE C 11 INJECTION safely and effectively. See full prescribing information for CHOLINE C 11 INJECTION. CHOLINE C 11 INJECTION, for intravenous use Initial U.S. Approval: 2012
Approved
Approval ID
61f00cb4-ea53-4ba6-a890-78586095d2f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2017
Manufacturers
FDA
The University of Texas MD Anderson Cancer Center
DUNS: 016568851
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Choline C 11
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60215-111
Application NumberANDA205690
Product Classification
M
Marketing Category
C73584
G
Generic Name
Choline C 11
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 19, 2017
FDA Product Classification
INGREDIENTS (2)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
CHOLINE C-11Active
Quantity: 100 mCi in 1 mL
Code: M4AS4XGD4Q
Classification: ACTIM