| NDC Code | 70121-1630-1 |
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| Package Description | 1 VIAL, GLASS in 1 BOX (70121-1630-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
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| Product NDC | 70121-1630 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Tepadina |
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| Non-Proprietary Name | Thiotepa |
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| Dosage Form | INJECTION, POWDER, FOR SOLUTION |
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| Usage | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
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| Start Marketing Date | 20170815 |
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| Marketing Category Name | NDA |
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| Application Number | NDA208264 |
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| Manufacturer | Amneal Pharmaceuticals LLC |
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| Substance Name | THIOTEPA |
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| Strength | 15 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |
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