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 |