| NDC Code | 0378-4500-93 |
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| Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4500-93) |
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| Product NDC | 0378-4500 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Budesonide |
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| Non-Proprietary Name | Budesonide |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20201020 |
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| End Marketing Date | 20240430 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA208851 |
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| Manufacturer | Mylan Pharmaceuticals Inc. |
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| Substance Name | BUDESONIDE |
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| Strength | 9 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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