| NDC Code | 71288-127-15 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-127-15) > 15 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 71288-127 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Topotecan |
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| Non-Proprietary Name | Topotecan Hydrochloride |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20190902 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA201166 |
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| Manufacturer | Meitheal Pharmaceuticals Inc. |
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| Substance Name | TOPOTECAN HYDROCHLORIDE |
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| Strength | 4 |
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| Strength Unit | mg/15mL |
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| Pharmacy Classes | Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA] |
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