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RYBREVANT FASPRO

BLA · Biologics License Application · Sponsor: JANSSEN BIOTECH · Approved 2026-02-13

Drug application

FDA Application #

BLA761484

Application type

Biologics License Application

Brand name

RYBREVANT FASPRO

Generic name

AMIVANTAMAB AND HYALURONIDASE-LPUJ (HUMAN RECOMBINANT)

Active ingredients

AMIVANTAMAB AND HYALURONIDASE-LPUJ

Dosage form

VIAL

Route

SINGLE-USE

Marketing status

Prescription

Sponsor

JANSSEN BIOTECH

Manufacturer

Janssen Biotech, Inc.

First approval

2026-02-13

Source

Authoritative

Drugs@FDA application overview

Machine

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