| NDC Code | 0054-0975-80 |
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| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (0054-0975-80) / 10 mL in 1 BOTTLE, DROPPER |
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| Product NDC | 0054-0975 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Neomycin And Polymyxin B Sulfates And Hydrocortisone |
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| Proprietary Name Suffix | Otic |
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| Non-Proprietary Name | Neomycin And Polymyxin B Sulfates And Hydrocortisone |
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| Dosage Form | SOLUTION/ DROPS |
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| Usage | AURICULAR (OTIC) |
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| Start Marketing Date | 20261008 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA220938 |
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| Manufacturer | Hikma Pharmaceuticals USA Inc. |
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| Substance Name | NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE |
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| Strength | 3.5; 10000; 10 |
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| Strength Unit | mg/mL; [iU]/mL; mg/mL |
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| Pharmacy Classes | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
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