dockets: FDA-2019-P-6049

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id agency_id title docket_type last_modified object_id rin dkabstract category subtype keywords program short_title effective_date organization attrs_raw attr_source
FDA-2019-P-6049 FDA Request that the FDA require that any abbreviated new drug application (ANDA) for a generic version of APOKYN seek approval of both the drug and device constituent parts of APOKYN Nonrulemaking 2020-05-21T16:19:45Z 0b00006484251113         ["Petition for Reconsideration", "CDER", "US WorldMeds, LLC", "require that anyANDA", "referencing APOKYN seek approval", "of both the drug and device constituent", "parts of APOKYN", "establish a policy framework clarifying", "the circumstances, if any, under", "which the drug constituent part of a", "generic drug-device combination", "product can be approved in an", "ANDA that does not also seek approval", "of the device constituent part", "OPEN"] CDER Request that the FDA require that any abbreviated new drug application (ANDA) for a generic version of APOKYN seek approval of both the drug and device constituent parts of APOKYN     {"displayProperties": [{"name": "generic", "label": "Docket Item Code", "tooltip": "An agency specific code that identifies the type of document that established the docket (regulatory action)."}, {"name": "program", "label": "Center", "tooltip": "The agency specific program associated with the docket (regulatory action); equivalents: Docket Item Code, Location."}, {"name": "field2", "label": "Docket Status", "tooltip": "Used to Identity that a Docket's Status is Open or Closed"}, {"name": "shortTitle", "label": "Short Title", "tooltip": "A combination of letters and or numbers assigned to an agency's regulatory action for purposes of brevity."}], "keywords": ["Petition for Reconsideration", "CDER", "US WorldMeds, LLC", "require that anyANDA", "referencing APOKYN seek approval", "of both the drug and device constituent", "parts of APOKYN", "establish a policy framework clarifying", "the circumstances, if any, under", "which the drug constituent part of a", "generic drug-device combination", "product can be approved in an", "ANDA that does not also seek approval", "of the device constituent part", "OPEN"], "modifyDate": "2020-05-21T16:19:45Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "Request that the FDA require that any abbreviated new drug application (ANDA) for a generic version of APOKYN seek approval of both the drug and device constituent parts of APOKYN", "subType2": null, "title": "Request that the FDA require that any abbreviated new drug application (ANDA) for a generic version of APOKYN seek approval of both the drug and device constituent parts of APOKYN", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b00006484251113"} single_get

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