{
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"PackageDescription": "500 TABLET in 1 BOTTLE (59746-802-05) ",
"NDC11Code": "59746-0802-05",
"ProductNDC": "59746-802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ProprietaryNameSuffix": null,
"NonProprietaryName": "Roflumilast",
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"RouteName": "ORAL",
"StartMarketingDate": "20260202",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208236",
"LabelerName": "Jubilant Cadista Pharmaceuticals Inc.",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "500",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260202",
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"SamplePackage": "N"
}
}