FDA.reportPublic FDA data

Application 761484

Type
BLA
Sponsor
JANSSEN BIOTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761484Rybrevant Fasproamivantamab and hyaluronidase-lpuj351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RYBREVANT FASPROAMIVANTAMAB AND HYALURONIDASE-LPUJVIAL; SINGLE-USE1,600MG/20,000 UNITS PER 10MLNoNo
002RYBREVANT FASPROAMIVANTAMAB AND HYALURONIDASE-LPUJVIAL; SINGLE-USE2,240MG/28,000 UNITS PER 14MLNoNo
003RYBREVANT FASPROAMIVANTAMAB AND HYALURONIDASE-LPUJVIAL; SINGLE-USE2,400MG/30,000 UNITS PER 15MLNoNo
004RYBREVANT FASPROAMIVANTAMAB AND HYALURONIDASE-LPUJVIAL; SINGLE-USE3,5200MG/44,000 UNITS PER 22MLNoNo

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
Rybrevant FasproAMIVANTAMAB AND HYALURONIDASE-LPUJ (HUMAN RECOMBINANT)Janssen Biotech, Inc.9e58b045-e352-4f62-99bf-77fae1bebc692026-06-17Warnings, Adverse reactionsName fallback
brand name: Rybrevant Faspro

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85093ORIG 2026-02-20
85056ORIG 2026-02-20