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FDA ANDA · ANDA203777
SODIUM FLUORIDE F 18
sodium fluoride f-18
Sponsor: 3D IMAGING DRUG
APPLICATION
ANDA203777
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-19
LATEST ACTION
2020-06-24
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM FLUORIDE F-18Prescription
SODIUM FLUORIDE F-18 10-200mCi/ML · INJECTABLE · INTRAVENOUS
Approval history
2020-06-24Manufacturing (CMC) · Supplement 1 · unknownAP
2015-10-19UNKNOWN · 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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