| NDC Code | 0480-3081-31 |
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| Package Description | 1 POUCH in 1 CARTON (0480-3081-31) / 1 CANISTER in 1 POUCH / 120 AEROSOL, METERED in 1 CANISTER |
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| Product NDC | 0480-3081 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Budesonide And Formoterol Fumarate Dihydrate |
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| Non-Proprietary Name | Budesonide And Formoterol Fumarate Dihydrate |
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| Dosage Form | AEROSOL, METERED |
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| Usage | RESPIRATORY (INHALATION) |
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| Start Marketing Date | 20260527 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA212212 |
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| Manufacturer | Teva Pharmaceuticals, Inc. |
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| Substance Name | BUDESONIDE; FORMOTEROL FUMARATE |
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| Strength | 160; 4.5 |
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| Strength Unit | ug/1; ug/1 |
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| Pharmacy Classes | Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC] |
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