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Hepcludex
bulevirtide-gmod
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Hepcludex
Proper name
bulevirtide-gmod
Licence type
351(a)
BLA number
761468
Applicant
Gilead Sciences, Inc.
Center
CDER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 8.5MG | For Injection | Subcutaneous | Single-Dose Vial | Rx | May 22, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |