APPLICATION
ANDA203603
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-13
LATEST ACTION
2018-09-27
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUDEOXYGLUCOSE F18Prescription
FLUDEOXYGLUCOSE F-18 20-300mCi/ML · INJECTABLE · INTRAVENOUS
FLUDEOXYGLUCOSE F18Prescription
FLUDEOXYGLUCOSE F-18 20-500mCi/ML · INJECTABLE · INTRAVENOUS
Approval history
2018-09-27Manufacturing (CMC) · Supplement 7AP
2015-11-13UNKNOWN · 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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