{
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"PackageDescription": "10 BOTTLE, GLASS in 1 CARTON (70121-1389-7) / 100 mL in 1 BOTTLE, GLASS (70121-1389-1) ",
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"ProprietaryName": "Dexmedetomidine Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200520",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207551",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
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"Status": "Active",
"LastUpdate": "2024-07-09",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200520",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}