| 76125-900-25 |
76125-900 |
PLASMA DERIVATIVE |
GAMMAKED |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
KEDRION BIOPHARMA, INC. |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (76125-900-25) / 25 mL in 1 VIAL, GLASS (76125-900-26) |
| 76125-900-50 |
76125-900 |
PLASMA DERIVATIVE |
GAMMAKED |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
KEDRION BIOPHARMA, INC. |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (76125-900-50) / 50 mL in 1 VIAL, GLASS (76125-900-51) |
| 76125-900-20 |
76125-900 |
PLASMA DERIVATIVE |
GAMMAKED |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
KEDRION BIOPHARMA, INC. |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (76125-900-20) / 200 mL in 1 VIAL, GLASS (76125-900-21) |
| 76125-900-10 |
76125-900 |
PLASMA DERIVATIVE |
GAMMAKED |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
KEDRION BIOPHARMA, INC. |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (76125-900-10) / 100 mL in 1 VIAL, GLASS (76125-900-11) |
| 76125-900-01 |
76125-900 |
PLASMA DERIVATIVE |
GAMMAKED |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
KEDRION BIOPHARMA, INC. |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (76125-900-01) / 10 mL in 1 VIAL, GLASS (76125-900-02) |
| 13533-800-12 |
13533-800 |
PLASMA DERIVATIVE |
Gamunex-C |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
GRIFOLS USA, LLC |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (13533-800-12) / 10 mL in 1 VIAL, GLASS (13533-800-13) |
| 13533-800-40 |
13533-800 |
PLASMA DERIVATIVE |
Gamunex-C |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
GRIFOLS USA, LLC |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (13533-800-40) / 400 mL in 1 VIAL, GLASS (13533-800-41) |
| 13533-800-71 |
13533-800 |
PLASMA DERIVATIVE |
Gamunex-C |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
GRIFOLS USA, LLC |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (13533-800-71) / 100 mL in 1 VIAL, GLASS (13533-800-72) |
| 13533-800-15 |
13533-800 |
PLASMA DERIVATIVE |
Gamunex-C |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
GRIFOLS USA, LLC |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (13533-800-15) / 25 mL in 1 VIAL, GLASS (13533-800-16) |
| 13533-800-20 |
13533-800 |
PLASMA DERIVATIVE |
Gamunex-C |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
GRIFOLS USA, LLC |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (13533-800-20) / 50 mL in 1 VIAL, GLASS (13533-800-21) |
| 13533-800-24 |
13533-800 |
PLASMA DERIVATIVE |
Gamunex-C |
Immune Globulin (Human) |
INJECTION |
INTRAVENOUS; SUBCUTANEOUS |
20101013 |
N/A |
BLA |
BLA125046 |
GRIFOLS USA, LLC |
HUMAN IMMUNOGLOBULIN G |
10 g/100mL |
1 VIAL, GLASS in 1 CARTON (13533-800-24) / 200 mL in 1 VIAL, GLASS (13533-800-25) |