{
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"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (42337-005-02) / 7.5 mL in 1 VIAL, SINGLE-DOSE (42337-005-01) ",
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"NonProprietaryName": "Gadobutrol",
"DosageFormName": "INJECTION",
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"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219287",
"LabelerName": "Viwit Pharmaceutical Co., Ltd.",
"SubstanceName": "GADOBUTROL",
"StrengthNumber": "604.72",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]",
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"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260611",
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"SamplePackage": "N"
}
}