| NDC Code | 70257-054-51 |
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| Package Description | 1 VIAL, GLASS in 1 CARTON (70257-054-51) / 5 mL in 1 VIAL, GLASS (70257-054-05) |
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| Product NDC | 70257-054 |
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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 | Human Hepatitis B Virus Immune Globulin |
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| Dosage Form | INJECTION, SOLUTION |
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| Usage | INTRAMUSCULAR; INTRAVENOUS |
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| Start Marketing Date | 20180620 |
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| End Marketing Date | 20240430 |
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| Marketing Category Name | BLA |
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| Application Number | BLA125035 |
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| Manufacturer | Saol Therapeutics Inc. |
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| Substance Name | HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN |
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| Strength | 312 |
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| Strength Unit | [iU]/mL |
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| Pharmacy Classes | Human Immunoglobulin [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE], Virus Neutralization [MoA], Virus-specific Hyperimmune Globulins [EXT] |
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