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FDA NDA · NDA208399

VARUBI

Sponsor: TERSERA

APPLICATION
NDA208399
TYPE
NDA
ORIGINAL APPROVAL
2017-10-25
LATEST ACTION
2020-08-19
ROUTE
INTRAVENOUS
DOSAGE FORM
EMULSION
MARKETING STATUS
Discontinued

Products

VARUBI · ReferenceDiscontinued
ROLAPITANT HYDROCHLORIDE EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML) · EMULSION · INTRAVENOUS

Approval history

2020-08-19Labeling · Supplement 4 · standard — Label ↗AP
2018-04-13Labeling · Supplement 2 · standard — Label ↗AP
2017-10-25Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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