Application 761268

Type
BLA
Sponsor
CELLTRION

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761268Vegzelmabevacizumab-adcd351(k) BiosimilarRx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VEGZELMABEVACIZUMAB-ADCDINJECTABLE;INJECTION100MG/4ML(25MG/ML)NoNo
002VEGZELMABEVACIZUMAB-ADCDINJECTABLE;INJECTION400MG/16ML(25MG/ML)NoNo

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
VegzelmaBEVACIZUMAB-ADCDCELLTRION USA, Inc.4cdcccda-7b9a-49d0-ac50-f4605a3c0ebe2025-05-08Warnings, Adverse reactionsExact identifier
application number: BLA761268

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72872ORIG2022-12-13
72170ORIG2022-09-29
72167ORIG2022-09-28