Varubi

NDA 208399, held by Tersera. Rolapitant Hydrochloride.

As of Nov 13, 2026, NDA 208399 (Varubi), held by Tersera, was first approved by FDA on Oct 25, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 25, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 25, 2017	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
VarubiEQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) · emulsion;intravenous	Rolapitant Hydrochloride	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Aug 19, 2020	Supplement 4Labeling · Standard review	Approved	Letter Label
Apr 13, 2018	Supplement 2Labeling · Standard review	Approved	Label Letter
Oct 25, 2017	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 208399
Drugs@FDA: Overview at FDA
Company: Tersera

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters