General MedicationsINTRAVENOUSStandard
VILTEPSO
VILTOLARSEN
Standard Dose
250MG/5ML (50MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview VILTEPSO is listed in Drugs@FDA under application 212154 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient VILTOLARSEN Form and strength SOLUTION;INTRAVENOUS - 250MG/5ML (50MG/ML) Sponsor NIPPON SHINYAKU Submission history Latest submission status date: 2021-03-11 00:00:00.
Structured Monograph
Clinical summary
Approval overview VILTEPSO is listed in Drugs@FDA under application 212154 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient VILTOLARSEN Form and strength SOLUTION;INTRAVENOUS - 250MG/5ML (50MG/ML) Sponsor NIPPON SHINYAKU Submission history Latest submission status date: 2021-03-11 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.