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ODEFSEY

NDA · New Drug Application · Sponsor: GILEAD SCIENCES INC · Approved 2016-03-01

Drug application

FDA Application #

NDA208351

Application type

New Drug Application

Brand name

ODEFSEY

Generic name

EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR ALAFENAMIDE

Active ingredients

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

GILEAD SCIENCES INC

Manufacturer

Gilead Sciences, Inc.

First approval

2016-03-01

Source

Authoritative

Drugs@FDA application overview

Machine

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