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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
5X10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25X10^6 VIABLE CD34+ CELLS
Bag
351(a)
Rx
Proper Name
HPC, Cord Blood
BLA Number
125391
Applicant
Clinimmune Labs
Original Approval Date
May 24, 2012
Date of First Licensure
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