| NDC Code | 68083-503-01 |
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| Package Description | 1 VIAL in 1 CARTON (68083-503-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
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| Product NDC | 68083-503 |
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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 | 20220103 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA214222 |
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| Manufacturer | Gland Pharma Limited |
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| Substance Name | THIOTEPA |
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| Strength | 100 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |
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