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BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)

NDA · New Drug Application · Sponsor: GILEAD SCIENCES INC · Approved 2026-08-27

Drug application

FDA Application #

NDA221443

Application type

New Drug Application

Brand name

BIXLENVO SUNLENCA STARTER PACK (COPACKAGED)

Generic name

Bictegravir Sodium, Lenacapavir Sodium

Active ingredients

BICTEGRAVIR SODIUM, LENACAPAVIR SODIUM; LENACAPAVIR SODIUM

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

GILEAD SCIENCES INC

First approval

2026-08-27

Source

Authoritative

Drugs@FDA application overview

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