{
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"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01) > 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "68083-0381-01",
"ProductNDC": "68083-381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irinotecan Hydrochloide",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Irinotecan Hydrochloide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191118",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212993",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "IRINOTECAN HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2022-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191118",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}