{
"NDC": {
"NDCCode": "72694-617-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (72694-617-60) / 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "72694-0617-60",
"ProductNDC": "72694-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tibsovo",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Ivosidenib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20211019",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211192",
"LabelerName": "Servier Pharmaceutical LLC",
"SubstanceName": "IVOSIDENIB",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Isocitrate Dehydrogenase 1 Inhibitor [EPC], Isocitrate Dehydrogenase 1 Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2024-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211019",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}