FDA.reportPublic FDA data

Application 761427

Type
BLA
Sponsor
LIB THERAPEUTICS, INC.

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761427Lerochollerodalcibep-liga351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEROCHOLLERODALCIBEP-LIGAINJECTABLE;INJECTION300MG/1.2MLNoNo

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.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEROCHOLLERODALCIBEP-LIGALIB Therapeutics, Inc.422f8b04-6ce8-4e64-a0a9-0ccc9a4a58602026-07-28Adverse reactionsExact identifier
application number: BLA761427

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84729ORIG 2026-01-09
84421ORIG 2025-12-15