| NDC Code | 50580-434-01 |
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| Package Description | 2 BLISTER PACK in 1 CARTON (50580-434-01) / 8 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK |
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| Product NDC | 50580-434 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Sudafed Sinus 12 Hour Pressure Plus Pain |
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| Non-Proprietary Name | Naproxen Sodium And Pseudoephedrine Hydrochloride |
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| Dosage Form | TABLET, MULTILAYER, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20190617 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA076518 |
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| Manufacturer | Kenvue Brands LLC |
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| Substance Name | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
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| Strength | 220; 120 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC] |
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