| NDC Code | 83634-204-02 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-204-02) / 1.5 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 83634-204 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Thiotepa |
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| Non-Proprietary Name | Thiotepa |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRACAVITARY; INTRAVENOUS; INTRAVESICAL |
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| Start Marketing Date | 20251001 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA211831 |
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| Manufacturer | Avenacy, LLC |
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| Substance Name | THIOTEPA |
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| Strength | 15 |
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| Strength Unit | mg/1.5mL |
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| Pharmacy Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |
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