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Hemacord

Hematopoietic Progenitor Cells, Cord (HPC-C)

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Hemacord

Proper name

Hematopoietic Progenitor Cells, Cord (HPC-C)

Licence type

351(a)

BLA number

125397

Applicant

New York Blood Center, Inc.

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
5 X 10E8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25 X 10E6 VIABLE CD34+ CELLS U	Injection	Intravenous	Bag	Rx	November 10, 2011

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