| NDC Code | 53746-831-53 |
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| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53) / 7.5 mL in 1 BOTTLE, PLASTIC |
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| Product NDC | 53746-831 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Ciprofloxacin And Dexamethasone |
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| Non-Proprietary Name | Ciprofloxacin And Dexamethasone |
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| Dosage Form | SUSPENSION/ DROPS |
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| Usage | AURICULAR (OTIC) |
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| Start Marketing Date | 20240326 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA216501 |
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| Manufacturer | Amneal Pharmaceuticals of New York LLC |
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| Substance Name | CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE |
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| Strength | 3; 1 |
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| Strength Unit | mg/mL; mg/mL |
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| Pharmacy Classes | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS] |
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