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VARUBI

NDA · New Drug Application · Sponsor: TERSERA · Approved 2015-09-01

Drug application

FDA Application #

NDA206500

Application type

New Drug Application

Brand name

VARUBI

Generic name

ROLAPITANT

Active ingredients

ROLAPITANT HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

TERSERA

Manufacturer

TerSera Therapeutics LLC

First approval

2015-09-01

Source

Authoritative

Drugs@FDA application overview

Machine

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