Gamunex-C - Immune Globulin Intravenous (Human), 10% Caprylate Chromatography Purified
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Field |
Value |
NDC Code: |
13533-800 |
Proprietary Name: |
Gamunex-C |
Suffix: |
|
Non-Proprietary Name: |
Immune Globulin Intravenous (Human), 10% Caprylate Chromatography Purified |
Dosage Form: |
INJECTION |
Method: |
INTRAVENOUS |
Original Marketing Date: |
13-10-2010 |
Category Name: |
BLA |
Application Number: |
BLA125046 |
Labeler: |
GRIFOLS THERAPEUTICS INC. |
Substance Name: |
HUMAN IMMUNOGLOBULIN G |
Active Numerator Strength: |
10 |
Active Ingredient Unit: |
g/100mL |
Pharm Classes: |
Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [Chemical/Ingredient] |
DEA Schedule: |
|