Product Details for: Hepcludex

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Subcutaneous
8.5MG
Single-Dose Vial
351(a)
Hepcludex
Rx
Proper Name
bulevirtide-gmod
BLA Number
761468
Applicant
Gilead Sciences, Inc.
Original Approval Date
May 22, 2026
Date of First Licensure
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