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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2004 Biological License Application Approvals

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval.


Tradename/
Proper Name
Indication for Use STN Manufacturer/
License Number
Approval Date
Rhophylac
Rho(D) Immune Globulin Intravenous (Human)
Routine antepartum and postpartum prevention of Rho(D) immunization in Rho(D)-negative women, for Rhesus prophylaxis in case of obstetric complications, for Rhesus prophylaxis in case of invasive procedures during pregnancy, and for the suppression of Rhesus immunization in Rho(D)-negative individuals transfused with Rho(D)-positive red blood cells (RBCs) or blood components containing Rho(D)-positive RBCs 125070/0 ZLB Bioplasma AG
Wankdorfstrasse 10
Postfach, 3000
Bern 22
Switzerland
License 1598
2/12/2004
Source Plasma For further manufacture 125081/0 Franklinton Blood Plasma, LLC
1128 Main Street
Cincinnati, OH 45202
License 1691
5/14/2004
OCTAGAM
Immune Globulin Intravenous (Human)
Treatment of primary immune deficient diseases 125062/0 OCTAPHARMA Pharmazeutika Produktionsges.m.b.H
Oberlaaer Strasse 235
A-1100
Vienna
Austria
License 1646
5/21/2004
Source Plasma For further manufacture 125082/0 DCI Biologicals Temple Terrace LLC
2051 Range Road
Clearwater, FL 33765
License 1693
10/21/2004