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FDA NDA · NDA206500

VARUBI

rolapitant

Sponsor: TERSERA

APPLICATION
NDA206500
TYPE
NDA
ORIGINAL APPROVAL
2015-09-01
LATEST ACTION
2020-08-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VARUBI · ReferencePrescription
ROLAPITANT HYDROCHLORIDE EQ 90MG BASE · TABLET · ORAL

Approval history

2020-08-19Labeling · Supplement 8 · standard — Label ↗AP
2018-04-13Labeling · Supplement 3 · standard — Label ↗AP
2016-04-22Manufacturing (CMC) · Supplement 2 · standardAP
2016-04-04Manufacturing (CMC) · Supplement 1 · standardAP
2015-09-01Type 1 - New Molecular Entity · Original · standard — Letter ↗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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