| NDC Code | 63402-681-12 |
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| Package Description | 2 BLISTER PACK in 1 CARTON (63402-681-12) > 6 CAPSULE in 1 BLISTER PACK (63402-681-02) > 1 CAPSULE in 1 CAPSULE |
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| Product NDC | 63402-681 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Utibron Neohaler |
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| Non-Proprietary Name | Indacaterol Maleate And Glycopyrrolate |
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| Dosage Form | CAPSULE |
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| Usage | RESPIRATORY (INHALATION) |
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| Start Marketing Date | 20151029 |
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| End Marketing Date | 20210430 |
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| Marketing Category Name | NDA |
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| Application Number | NDA207930 |
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| Manufacturer | Sunovion Pharmaceuticals Inc. |
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| Substance Name | INDACATEROL MALEATE; GLYCOPYRROLATE |
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| Strength | 27.5; 15.6 |
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| Strength Unit | ug/1; ug/1 |
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| Pharmacy Classes | Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA] |
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