Product Details for: Zynteglo

RETURN TO SEARCH RESULTS
PRODUCT LABEL Grayed out Product Label links indicate that there is no product label available for the product.
Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
1.7-20 X 10^6CELL/ML
Bag
351(a)
Zynteglo
Rx
Proper Name
betibeglogene autotemcel
BLA Number
125717
Applicant
Genetix Biotherapeutics Inc.
Original Approval Date
August 17, 2022
Date of First Licensure
08/17/2022
RETURN TO SEARCH RESULTS