# HEPCLUDEX
> **BLA761468** · Biologics License Application · Sponsor: GILEAD SCIENCES INC · Approved 2026-05-22
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761468)
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*MORVS · CC0 1.0*