Product Details for: Aucatzyl
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Intravenous
410 10^6CAR+ T CELLS TOTAL; DELIVERED AS A SPLIT DOSE IN 3-5 BAGS ON DAY 1 & 10
Bag
351(a)
Aucatzyl
Rx
Proper Name
Obecabtagene autoleucel
Obecabtagene autoleucel
BLA Number
125813
125813
Applicant
Autolus, Inc.
Autolus, Inc.
Original Approval Date
November 8, 2024
November 8, 2024
Date of First Licensure
11/08/2024
11/08/2024