Vaccines, Blood & Biologics
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HPC, Cord Blood
STN: BL 125391/0
Proper Name: HPC, Cord Blood
Trade Name: None
Manufacture: Clinimmune Labs, University of Colorado Cord Blood Bank
Indication: For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
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Supporting Documents
May 24, 2012 Approval Letter - HPC, Cord Blood
Indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic…Summary Basis for Regulatory Action, May 24, 2012 - HPC, Cord Blood (PDF - 155KB)Approval History, Letters, Reviews and Related Documents - HPC, Cord Blood
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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