Application 761427
- Type
- BLA
- Sponsor
- LIB THERAPEUTICS, INC.
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761427 | Lerochol | lerodalcibep-liga | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEROCHOL | LERODALCIBEP-LIGA | INJECTABLE;INJECTION | 300MG/1.2ML | 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 |
|---|---|---|---|---|---|---|
| LEROCHOL | LERODALCIBEP-LIGA | LIB Therapeutics, Inc. | 422f8b04-6ce8-4e64-a0a9-0ccc9a4a5860 | 2026-07-28 | Adverse reactions | BLA761427 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.