| NDC Code | 84558-005-01 |
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| Package Description | 200 mL in 1 BOTTLE (84558-005-01) |
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| Product NDC | 84558-005 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | 1% Ketoconazole Anti Dandruff |
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| Non-Proprietary Name | 1% Ketoconazole Anti Dandruff Shampoo |
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| Dosage Form | SHAMPOO |
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| Usage | CUTANEOUS |
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| Start Marketing Date | 20241204 |
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| Marketing Category Name | OTC MONOGRAPH DRUG |
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| Application Number | 505G(a)(3) |
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| Manufacturer | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd |
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| Substance Name | KETOCONAZOLE |
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| Strength | 1 |
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| Strength Unit | g/100mL |
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| Pharmacy Classes | Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
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