HyperHEP B S/D - Hepatitis B Immune Globulin (Human)
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Field |
Value |
NDC Code: |
13533-636 |
Proprietary Name: |
HyperHEP B S/D |
Suffix: |
|
Non-Proprietary Name: |
Hepatitis B Immune Globulin (Human) |
Dosage Form: |
INJECTION |
Method: |
INTRAMUSCULAR |
Original Marketing Date: |
09-10-1996 |
Category Name: |
BLA |
Application Number: |
BLA101146 |
Labeler: |
GRIFOLS THERAPEUTICS INC. |
Substance Name: |
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
Active Numerator Strength: |
220 |
Active Ingredient Unit: |
[iU]/mL |
Pharm Classes: |
Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] |
DEA Schedule: |
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