Product Details for: Tecartus
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
2×10^6 CAR-positive viable T cells per kg body weight
Bag
351(a)
Tecartus
Rx
Proper Name
Brexucabtagene Autoleucel
Brexucabtagene Autoleucel
BLA Number
125703
125703
Applicant
Kite Pharma, Inc.
Kite Pharma, Inc.
Original Approval Date
July 24, 2020
July 24, 2020
Date of First Licensure