{
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"PackageDescription": "90 CAPSULE in 1 BOTTLE (64406-250-90) ",
"NDC11Code": "64406-0250-90",
"ProductNDC": "64406-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Skyclarys",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Omaveloxolone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241115",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216718",
"LabelerName": "Biogen",
"SubstanceName": "OMAVELOXOLONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241115",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}