General MedicationsINTRAVENOUSStandard
KORSUVA
DIFELIKEFALIN ACETATE
Standard Dose
EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview KORSUVA is listed in Drugs@FDA under application 214916 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DIFELIKEFALIN ACETATE Form and strength SOLUTION;INTRAVENOUS - EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) Sponsor VIFOR INTL Submission history Latest submission status date: 2025-03-25 00:00:00.
Structured Monograph
Clinical summary
Approval overview KORSUVA is listed in Drugs@FDA under application 214916 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DIFELIKEFALIN ACETATE Form and strength SOLUTION;INTRAVENOUS - EQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) Sponsor VIFOR INTL Submission history Latest submission status date: 2025-03-25 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.