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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

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Choline C 11 - FDA Drug Approval Details