{
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"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1486-3) ",
"NDC11Code": "67046-1486-03",
"ProductNDC": "67046-1486",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"DosageFormName": "CAPSULE, EXTENDED RELEASE",
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"StartMarketingDate": "20250129",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040298",
"LabelerName": "Coupler LLC",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250129",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}