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HEPCLUDEX

BLA · Biologics License Application · Sponsor: GILEAD SCIENCES INC · Approved 2026-05-22

Drug application

FDA Application #

BLA761468

Application type

Biologics License Application

Brand name

HEPCLUDEX

Generic name

BULEVIRTIDE

Active ingredients

BULEVIRTIDE-GMOD

Dosage form

INJECTION

Route

POWDER,FOR SOLUTION

Marketing status

Prescription

Sponsor

GILEAD SCIENCES INC

Manufacturer

Gilead Sciences, Inc.

First approval

2026-05-22

Source

Authoritative

Drugs@FDA application overview

Machine

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