Product Details for: Rybrevant Faspro

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
1,600MG/10ML; 20,000UNITS/10ML (160MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Rybrevant Faspro
Rx
002
Injection
Subcutaneous
2,240MG/14ML; 28,000UNITS/14ML (160MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Rybrevant Faspro
Rx
003
Injection
Subcutaneous
2,400MG/15ML; 30,000UNITS (160MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Rybrevant Faspro
Rx
004
Injection
Subcutaneous
3,520MG/22ML; 44,000UNITS (160MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Rybrevant Faspro
Rx
Proper Name
amivantamab and hyaluronidase-lpuj
BLA Number
761484
Applicant
Janssen Biotech, Inc.
Original Approval Date
February 13, 2026
Date of First Licensure
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