{
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"PackageDescription": "4 TRAY in 1 CASE (0121-4577-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-4577-15) ",
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"RouteName": "ORAL",
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"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074623",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "LACTULOSE",
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"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"DEASchedule": null,
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"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19660730",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}