| NDC Code: |
53270-0051 |
| Proprietary Name: |
HepaGam B |
| Suffix: |
|
| Non-Proprietary Name: |
Hepatitis B Immune Globulin (Human) |
| Dosage Form: |
INJECTION, SOLUTION |
| Method: |
INTRAMUSCULAR; INTRAVENOUS |
| Original Marketing Date: |
01-08-2010 |
| Category Name: |
BLA |
| Application Number: |
BLA125035 |
| Labeler: |
CANGENE BIOPHARMA INC. |
| Substance Name: |
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
| Active Numerator Strength: |
312 |
| 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: |
|
