Product Details for: Darzalex Faspro

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Darzalex Faspro
Rx
Proper Name
daratumumab and hyaluronidase-fihj
BLA Number
761145
Applicant
Janssen Biotech, Inc.
Original Approval Date
May 1, 2020
Date of First Licensure
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