dockets: FDA-2013-P-1623

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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-2013-P-1623 FDA Refuse to Receive any ANDA for Asenapine Maleate Sublingual Tablets That Does not Contain the Results of a Bioequivalence Study Performed; Requests That the Fling Acceptance Date of any ANDA for Asenapine Sublingual Tablets be Based on the Date That the Application First Contained the Results of a Bioequivalence Study Nonrulemaking 2017-08-28T11:08:35Z 0b000064814bbbf6   Closed Denied 5/8/2014     ["cder", "citizen petition", "open", "2013-10196", "Sigmapharm", "ANDA", "Asenapine Sublingual Tablets", "bioequivalence", "refuse to receive"] CDER Refuse to Receive any ANDA for Asenapine Maleate Sublingual Tablets That Does not Contain the Results of a Bioequivalence Study Performed     {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"name": "legacyId", "label": "Legacy ID", "tooltip": "A pre-FDMS agency specific identifier migrated from a legacy system."}, {"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": ["cder", "citizen petition", "open", "2013-10196", "Sigmapharm", "ANDA", "Asenapine Sublingual Tablets", "bioequivalence", "refuse to receive"], "modifyDate": "2017-08-28T11:08:35Z", "dkAbstract": "Closed Denied 5/8/2014", "agencyId": "FDA", "program": "CDER", "shortTitle": "Refuse to Receive any ANDA for Asenapine Maleate Sublingual Tablets That Does not Contain the Results of a Bioequivalence Study Performed", "subType2": null, "title": "Refuse to Receive any ANDA for Asenapine Maleate Sublingual Tablets That Does not Contain the Results of a Bioequivalence Study Performed; Requests That the Fling Acceptance Date of any ANDA for Asenapine Sublingual Tablets be Based on the Date That the Application First Contained the Results of a Bioequivalence Study", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2013-10196", "subType": null, "category": null, "field2": "Closed", "effectiveDate": null, "objectId": "0b000064814bbbf6"} single_get

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