| NDC Code | 58602-834-78 |
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| Package Description | 2 BLISTER PACK in 1 CARTON (58602-834-78) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
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| Product NDC | 58602-834 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Guaifenesin And Pseudoephedrine Hcl |
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| Non-Proprietary Name | Guaifenesin And Pseudoephedrine Hcl |
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| Dosage Form | TABLET, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20200325 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA213203 |
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| Manufacturer | Aurohealth LLC |
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| Substance Name | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
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| Strength | 1200; 120 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC] |
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