FDA.reportPublic FDA data

Application 761367

Type
BLA
Sponsor
CSL BEHRING LLC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761367Andembrygaradacimab-gxii351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANDEMBRYGARADACIMAB-GXIIINJECTABLE;SUBCUTANEOUS200MG/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
ANDEMBRYGARADACIMABCSL07b0b671-db81-49f0-a402-0c0219db7fa22025-06-30Warnings, Adverse reactionsExact identifier
application number: BLA761367

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82891ORIG 2025-07-21
82644ORIG 2025-06-24
82593ORIG 2025-06-17