General MedicationsINTRAVENOUSStandard
AMYVID
FLORBETAPIR F-18
Standard Dose
10-100ML (13.5-51mCi/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview AMYVID is listed in Drugs@FDA under application 202008 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FLORBETAPIR F-18 Form and strength SOLUTION;INTRAVENOUS - 10-100ML (13.5-51mCi/ML) Sponsor AVID RADIOPHARMS INC Submission history Latest submission status date: 2025-06-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview AMYVID is listed in Drugs@FDA under application 202008 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLORBETAPIR F-18 Form and strength SOLUTION;INTRAVENOUS - 10-100ML (13.5-51mCi/ML) Sponsor AVID RADIOPHARMS INC 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.