{
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"PackageDescription": "1 CARTON in 1 KIT (42023-259-00) / 1 VIAL, MULTI-DOSE in 1 CARTON (42023-259-01) / 2.8 mL in 1 VIAL, MULTI-DOSE",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leuprolide Acetate",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
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"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217437",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "LEUPROLIDE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-07-01",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260630",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}