Application 761433

Type
BLA
Sponsor
JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RYBREVANT FASPROAMIVANTAMAB AND HYALURONIDASE-LPUJINJECTION10MLNoNo
002RYBREVANT FASPROAMIVANTAMAB AND HYALURONIDASE-LPUJINJECTION14MLNoNo

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 reactionsExact identifier
application number: BLA761433

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84785ORIG 2026-01-21
84462ORIG 2025-12-19