General MedicationsINTRAVENOUSGeneric
VARUBI
ROLAPITANT HYDROCHLORIDE
Standard Dose
EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview VARUBI is listed in Drugs@FDA under application 208399 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient ROLAPITANT HYDROCHLORIDE Form and strength EMULSION;INTRAVENOUS - EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) Sponsor TERSERA Submission history Latest submission status date: 2020-08-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview VARUBI is listed in Drugs@FDA under application 208399 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ROLAPITANT HYDROCHLORIDE Form and strength EMULSION;INTRAVENOUS - EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) Sponsor TERSERA Submission history Latest submission status date: 2020-08-19 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.