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Clevecord

HPC, Cord Blood

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Clevecord

Proper name

HPC, Cord Blood

Licence type

351(a)

BLA number

125594

Applicant

Cleveland Cord Blood Center

Center

CBER

Presentations

1

First licensure

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Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
5 x 10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25 x 106 VIABLE CD34+ CELLS	Injection	Intravenous	Bag	Rx	September 1, 2016

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity