| NDC Code | 53270-0054-1 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (53270-0054-1) > 5 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 53270-0054 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Hepagam B |
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| Non-Proprietary Name | Hepatitis B Immune Globulin (human) |
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| Dosage Form | INJECTION, SOLUTION |
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| Usage | INTRAMUSCULAR; INTRAVENOUS |
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| Start Marketing Date | 20100801 |
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| Marketing Category Name | BLA |
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| Application Number | BLA125035 |
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| Manufacturer | Cangene BioPharma, LLC |
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| Substance Name | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
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| Strength | 50 |
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| Strength Unit | mg/mL |
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| Pharmacy Classes | Human Immunoglobulin [EPC],Passively Acquired Immunity [PE],Virus Neutralization [MoA],Virus-specific Hyperimmune Globulins [Chemical/Ingredient],Immunoglobulins [Chemical/Ingredient] |
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