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HARVONI

NDA · New Drug Application · Sponsor: GILEAD SCIENCES INC · Approved 2019-08-28

Drug application

FDA Application #

NDA212477

Application type

New Drug Application

Brand name

HARVONI

Generic name

LEDIPASVIR AND SOFOSBUVIR

Active ingredients

LEDIPASVIR; SOFOSBUVIR

Dosage form

PELLETS

Route

ORAL

Marketing status

Prescription

Sponsor

GILEAD SCIENCES INC

Manufacturer

Gilead Sciences, Inc

First approval

2019-08-28

Source

Authoritative

Drugs@FDA application overview

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