| NDC Code | 70000-0475-1 |
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| Package Description | 10 BLISTER PACK in 1 CARTON (70000-0475-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
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| Product NDC | 70000-0475 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Leader 12 Hour Nasal Decongestant |
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| Non-Proprietary Name | Pseudoephedrine Hydrochloride |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20190211 |
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| End Marketing Date | 20270331 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA075153 |
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| Manufacturer | Cardinal Health 110, LLC. dba Leader |
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| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE |
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| Strength | 120 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
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