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FDA ANDA · ANDA203920
FLUDEOXYGLUCOSE F 18
fludeoxyglucose f-18
Sponsor: JUBILANT DRAXIMAGE
APPLICATION
ANDA203920
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-23
LATEST ACTION
2021-01-27
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUDEOXYGLUCOSE F18Prescription
FLUDEOXYGLUCOSE F-18 20-300mCi/ML · INJECTABLE · INTRAVENOUS
Approval history
2021-01-27Labeling · Supplement 5 · standardAP
2015-06-23UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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