APPLICATION
ANDA204498
TYPE
ANDA
ORIGINAL APPROVAL
2015-06-23
LATEST ACTION
2020-10-23
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUDEOXYGLUCOSE F18Prescription
FLUDEOXYGLUCOSE F-18 20-300mCi/ML · INJECTABLE · INTRAVENOUS
Approval history
2020-10-23Labeling · Supplement 2 · standardAP
2015-06-23UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.