| NDC Code | 13551-101-01 |
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| Package Description | 2 BOTTLE, PLASTIC in 1 CARTON (13551-101-01) > 30 mL in 1 BOTTLE, PLASTIC |
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| Product NDC | 13551-101 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Karbinal |
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| Proprietary Name Suffix | Er |
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| Non-Proprietary Name | Carbinoxamine Maleate |
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| Dosage Form | SUSPENSION, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20140103 |
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| Marketing Category Name | NDA |
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| Application Number | NDA022556 |
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| Manufacturer | Avadel Pharmaceuticals (USA), Inc. |
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| Substance Name | CARBINOXAMINE MALEATE |
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| Strength | 4 |
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| Strength Unit | mg/5mL |
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| Pharmacy Classes | Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] |
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