| NDC Code | 68180-151-09 |
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| Package Description | 1 BOTTLE in 1 CARTON (68180-151-09) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
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| Product NDC | 68180-151 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Mirabegron |
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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 | 20240419 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA209485 |
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| Manufacturer | Lupin Pharmaceuticals, Inc. |
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| Substance Name | MIRABEGRON |
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| Strength | 25 |
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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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