Product Details for: regenecyte

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
>/=1.25x10E6 VIABLE CD34+ CELLS/UNIT IN >/=9x10E8 TNCs/UNIT
Bag
351(a)
regenecyte
Rx
Proper Name
HPC, Cord Blood
BLA Number
125764
Applicant
StemCyte, Inc.
Original Approval Date
November 21, 2024
Date of First Licensure