| NDC Code | 70000-0634-1 |
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| Package Description | 4 BLISTER PACK in 1 CARTON (70000-0634-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
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| Product NDC | 70000-0634 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | 12hr Allergy And Congestion Relief |
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| Non-Proprietary Name | Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride |
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| Dosage Form | TABLET, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20220331 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA215434 |
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| Manufacturer | LEADER/ Cardinal Health 110, Inc. |
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| Substance Name | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
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| Strength | 60; 120 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC] |
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