| NDC Code | 31722-044-12 |
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| Package Description | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-044-12) |
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| Product NDC | 31722-044 |
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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, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20221011 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA215742 |
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| Manufacturer | Camber Pharmaceuticals, Inc. |
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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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