Application 761468
- Type
- BLA
- Sponsor
- GILEAD SCIENCES INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761468 | Hepcludex | bulevirtide-gmod | 351(a) | Rx | 2026-08-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HEPCLUDEX | BULEVIRTIDE-GMOD | INJECTION;POWDER,FOR SOLUTION | 8.5MG | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HEPCLUDEX | BULEVIRTIDE | Gilead Sciences, Inc. | 12391cc2-38c2-4cf5-86d3-2be9370127fc | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | BLA761468 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.