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FDA ANDA · ANDA204333

FLUDEOXYGLUCOSE F 18

fludeoxyglucose f-18

Sponsor: MA GENERAL HOSP

APPLICATION
ANDA204333
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-25
LATEST ACTION
2021-02-24
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FLUDEOXYGLUCOSE F18Prescription
FLUDEOXYGLUCOSE F-18 20-300mCi/ML · INJECTABLE · INTRAVENOUS

Approval history

2021-02-24Labeling · Supplement 5 · standardAP
2016-02-26Labeling · Supplement 2 · standardAP
2014-09-25UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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