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Lerochol
lerodalcibep-liga
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Lerochol
Proper name
lerodalcibep-liga
Licence type
351(a)
BLA number
761427
Applicant
LIB Therapeutics, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 300MG/1.2ML (250MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | December 12, 2025 |
| 300MG/1.2ML (250MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | August 13, 2026 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |