General MedicationsINTRAVENOUSStandard
VIZAMYL
FLUTEMETAMOL F-18
Standard Dose
121.5mCi/30ML (4.05mCi/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview VIZAMYL is listed in Drugs@FDA under application 203137 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FLUTEMETAMOL F-18 Form and strength INJECTABLE;INTRAVENOUS - 121.5mCi/30ML (4.05mCi/ML) Sponsor GE HEALTHCARE Submission history Latest submission status date: 2025-06-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview VIZAMYL is listed in Drugs@FDA under application 203137 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLUTEMETAMOL F-18 Form and strength INJECTABLE;INTRAVENOUS - 121.5mCi/30ML (4.05mCi/ML) Sponsor GE HEALTHCARE Submission history Latest submission status date: 2025-06-23 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.