{
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"PackageDescription": "1 SYRINGE in 1 CARTON (85043-075-05) / .25 mL in 1 SYRINGE",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vabrinty",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20251215",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021343",
"LabelerName": "URONOVA PHARMACEUTICALS, INC.",
"SubstanceName": "LEUPROLIDE ACETATE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/.25mL",
"Pharm_Classes": "Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251215",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}