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FDA ANDA · ANDA203837

FLUDEOXYGLUCOSE F18

fludeoxyglucose f-18

Sponsor: BIOMEDCL RES FDN

APPLICATION
ANDA203837
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-01
LATEST ACTION
2021-01-22
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2021-01-22Labeling · Supplement 1 · standardAP
2015-05-01UNKNOWN · OriginalAP
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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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