General MedicationsINTRAVENOUSStandard
PARSABIV
ETELCALCETIDE
Standard Dose
2.5MG/0.5ML (2.5MG/0.5ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview PARSABIV is listed in Drugs@FDA under application 208325 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ETELCALCETIDE Form and strength SOLUTION;INTRAVENOUS - 2.5MG/0.5ML (2.5MG/0.5ML) Sponsor KAI PHARMS INC Submission history Latest submission status date: 2021-02-11 00:00:00.
Structured Monograph
Clinical summary
Approval overview PARSABIV is listed in Drugs@FDA under application 208325 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ETELCALCETIDE Form and strength SOLUTION;INTRAVENOUS - 2.5MG/0.5ML (2.5MG/0.5ML) Sponsor KAI PHARMS INC Submission history Latest submission status date: 2021-02-11 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.