{
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"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (84826-002-01) / 2.5 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "84826-0002-01",
"ProductNDC": "84826-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omlonti",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Omidenepag Isopropyl",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220923",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215092",
"LabelerName": "Ocuvex Therapeutics, Inc.",
"SubstanceName": "OMIDENEPAG ISOPROPYL",
"StrengthNumber": ".02",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin E2 Receptor Agonist [EPC], Prostaglandin E2 Receptor Agonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250428",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}