| NDC Code | 0008-0100-01 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 0008-0100 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Besponsa |
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| Non-Proprietary Name | Inotuzumab Ozogamicin |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20170818 |
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| Marketing Category Name | BLA |
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| Application Number | BLA761040 |
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| Manufacturer | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. |
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| Substance Name | INOTUZUMAB OZOGAMICIN |
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| Strength | .25 |
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| Strength Unit | mg/mL |
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| Pharmacy Classes | CD22-directed Antibody Interactions [MoA], CD22-directed Immunoconjugate [EPC], Decreased DNA Integrity [PE], Immunoconjugates [CS], Increased Cellular Death [PE] |
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