| NDC Code | 71288-117-06 |
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| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-117-06) / 5.26 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 71288-117 |
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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 Hydrochloride |
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| Dosage Form | INJECTION, SOLUTION |
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| Usage | INTRAVENOUS |
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| Start Marketing Date | 20201211 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA212129 |
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| Manufacturer | Meitheal Pharmaceuticals Inc. |
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| Substance Name | GEMCITABINE HYDROCHLORIDE |
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| Strength | 38 |
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| Strength Unit | mg/mL |
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| Pharmacy Classes | Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC] |
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