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FLUDEOXYGLUCOSE F18 (nda020306)- (4-40mCi/ML,4-90mCi/ML)

FLUDEOXYGLUCOSE F-18 DOWNSTATE CLINCL
4-40mCi/ML,4-90mCi/ML
No No
Expired Expired
None None
None No
Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures .
2 0 2
Total Other Developers None
Drugs with Suitability No
4-40mCi/ML ** ** - - -
4-90mCi/ML ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
****** **** ********** ********** ** **********, *** ******* *********** *** ******** ***, *** *******, ********** (**) *****, ****** ****** (***) ***

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