| NDC Code | 35573-443-25 |
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| Package Description | 25 POUCH in 1 CARTON (35573-443-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE |
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| Product NDC | 35573-443 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Levalbuterol |
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| Non-Proprietary Name | Levalbuterol Hydrochloride |
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| Dosage Form | SOLUTION |
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| Usage | RESPIRATORY (INHALATION) |
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| Start Marketing Date | 20210401 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA203653 |
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| Manufacturer | Burel Pharmaceuticals, LLC |
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| Substance Name | LEVALBUTEROL HYDROCHLORIDE |
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| Strength | .31 |
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| Strength Unit | mg/3mL |
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| Pharmacy Classes | Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC] |
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