| NDC Code | 15054-0043-1 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 15054-0043 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Onivyde |
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| Non-Proprietary Name | Irinotecan Hydrochloride |
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| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20151022 |
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| Marketing Category Name | NDA |
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| Application Number | NDA207793 |
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| Manufacturer | Ipsen Biopharmaceuticals, Inc. |
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| Substance Name | IRINOTECAN HYDROCHLORIDE |
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| Strength | 4.3 |
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| Strength Unit | mg/mL |
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| Pharmacy Classes | Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA] |
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