| NDC Code | 0078-0664-19 |
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| Package Description | 60 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0664-19) > 1 CAPSULE in 1 BLISTER PACK (0078-0664-61) |
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| Product NDC | 0078-0664 |
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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 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 | 20190630 |
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| Marketing Category Name | NDA |
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| Application Number | NDA207930 |
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| Manufacturer | Novartis Pharmaceuticals Corporation |
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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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