| NDC Code | 66992-128-14 |
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| Package Description | 1 POUCH in 1 CARTON (66992-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 66992-128 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Otovel |
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| Non-Proprietary Name | Ciprofloxacin And Fluocinolone Acetonide |
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| Dosage Form | SOLUTION |
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| Usage | AURICULAR (OTIC) |
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| Start Marketing Date | 20211004 |
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| Marketing Category Name | NDA |
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| Application Number | NDA208251 |
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| Manufacturer | WraSer LLC |
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| Substance Name | CIPROFLOXACIN; FLUOCINOLONE ACETONIDE |
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| Strength | .75; .0625 |
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| Strength Unit | mg/.25mL; mg/.25mL |
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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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