| NDC Code | 70518-2435-1 |
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| Package Description | 30 POUCH in 1 BOX (70518-2435-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-2435-2) |
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| Product NDC | 70518-2435 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Myrbetriq |
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| Non-Proprietary Name | Mirabegron |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20191119 |
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| Marketing Category Name | NDA |
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| Application Number | NDA202611 |
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| Manufacturer | REMEDYREPACK INC. |
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| Substance Name | MIRABEGRON |
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| Strength | 50 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC] |
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