| NDC Code | 0310-4616-12 |
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| Package Description | 120 AEROSOL, METERED in 1 INHALER (0310-4616-12) |
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| Product NDC | 0310-4616 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Breztri |
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| Non-Proprietary Name | Budesonide, Glycopyrrolate, And Formoterol Fumarate |
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| Dosage Form | AEROSOL, METERED |
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| Usage | RESPIRATORY (INHALATION) |
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| Start Marketing Date | 20200723 |
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| Marketing Category Name | NDA |
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| Application Number | NDA212122 |
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| Manufacturer | AstraZeneca Pharmaceuticals LP |
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| Substance Name | BUDESONIDE; FORMOTEROL; GLYCOPYRROLATE |
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| Strength | 160; 4.8; 9 |
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| Strength Unit | ug/1; ug/1; ug/1 |
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| Pharmacy Classes | Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
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