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FDA ANDA · ANDA079086

FLUDEOXYGLUCOSE F 18

Sponsor: PETNET

APPLICATION
ANDA079086
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-25
LATEST ACTION
2020-01-03
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FLUDEOXYGLUCOSE F18Prescription
FLUDEOXYGLUCOSE F-18 20-200mCi/ML · INJECTABLE · INTRAVENOUS

Approval history

2020-01-03Labeling · Supplement 21 · standardAP
2011-10-27Labeling · Supplement 4AP
2011-02-25OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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