Product Details for: Rituxan Hycela
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
1,400MG/11.7ML; 23,400UNITS/11.7ML (120MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Rituxan Hycela
Rx
002
Injection
Subcutaneous
1,600MG/13.4ML; 26,800UNITS/13.4ML (120MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Rituxan Hycela
Rx
Proper Name
rituximab and hyaluronidase human
rituximab and hyaluronidase human
BLA Number
761064
761064
Applicant
Genentech, Inc.
Genentech, Inc.
Original Approval Date
June 22, 2017
June 22, 2017
Date of First Licensure