General MedicationsINTRAVENOUSStandard
AXUMIN
FLUCICLOVINE F-18
Standard Dose
9-221mCi/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview AXUMIN is listed in Drugs@FDA under application 208054 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FLUCICLOVINE F-18 Form and strength SOLUTION;INTRAVENOUS - 9-221mCi/ML Sponsor BLUE EARTH Submission history Latest submission status date: 2021-05-21 00:00:00.
Structured Monograph
Clinical summary
Approval overview AXUMIN is listed in Drugs@FDA under application 208054 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLUCICLOVINE F-18 Form and strength SOLUTION;INTRAVENOUS - 9-221mCi/ML Sponsor BLUE EARTH Submission history Latest submission status date: 2021-05-21 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.