| NDC Code | 64380-189-01 |
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| Package Description | 120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01) |
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| Product NDC | 64380-189 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Zileuton |
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| Non-Proprietary Name | Zileuton |
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| Dosage Form | TABLET, MULTILAYER, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20221015 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA212670 |
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| Manufacturer | Strides Pharma Science Limited |
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| Substance Name | ZILEUTON |
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| Strength | 600 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | 5-Lipoxygenase Inhibitor [EPC], 5-Lipoxygenase Inhibitors [MoA], Decreased Leukotriene Production [PE] |
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