| NDC Code | 0143-9394-01 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9394-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 0143-9394 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Gemcitabine |
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| Non-Proprietary Name | Gemcitabine |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20210625 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA206617 |
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| Manufacturer | Hikma Pharmaceuticals USA Inc. |
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| Substance Name | GEMCITABINE |
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| Strength | 200 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
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