| NDC Code | 63323-102-10 |
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| Package Description | 5 mL in 1 VIAL (63323-102-10) |
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| Product NDC | 63323-102 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Gemcitabine Hydrochloride |
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| Non-Proprietary Name | Gemcitabine Hydrochloride |
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| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20110912 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA077983 |
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| Manufacturer | APP Pharmaceuticals, LLC |
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| Substance Name | GEMCITABINE HYDROCHLORIDE |
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| Strength | 200 |
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| Strength Unit | mg/5mL |
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| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC] |
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