Product Details for: Yescarta
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
2 × 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT
Bag
351(a)
Yescarta
Rx
Proper Name
axicabtagene ciloleucel
axicabtagene ciloleucel
BLA Number
125643
125643
Applicant
Kite Pharma, Inc.
Kite Pharma, Inc.
Original Approval Date
October 18, 2017
October 18, 2017
Date of First Licensure