| NDC Code | 68083-148-01 |
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| Package Description | 1 VIAL in 1 CARTON (68083-148-01) > 5 mL in 1 VIAL |
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| Product NDC | 68083-148 |
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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 | 20160201 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA204520 |
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| Manufacturer | Gland Pharma Limited |
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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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