| NDC Code | 63323-125-53 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 BOX (63323-125-53) / 25 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 63323-125 |
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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 | 20110726 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA090799 |
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| Manufacturer | Fresenius Kabi USA, LLC |
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| Substance Name | GEMCITABINE HYDROCHLORIDE |
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| Strength | 1 |
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| Strength Unit | g/25mL |
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| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
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