dockets: FDA-2016-P-4585

Regulatory dockets from Regulations.gov — containers for related documents and comments in a rulemaking proceeding.

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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-2016-P-4585 FDA Request the Food and Drug Administration carefully consider the sufficiency of the identification and qualification of potentially genotoxic impurities in reviewing any ANDA referencing AMPYRA (dalfampridine) Extended Release Tablets. CLOSED Nonrulemaking 2019-07-08T09:04:35Z 0b0000648243b5da   CLOSED     ["CDER", "2016-7417", "genotoxic impurities", "ANDA referencing AMPYRA", "dalfampridine Extended Release Tablets", "CLOSED"] CDER Request the Food and Drug Administration carefully consider the sufficiency of the applicants identification and qualification of potentially genotoxic impurities in reviewing any ANDA.     {"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", "2016-7417", "genotoxic impurities", "ANDA referencing AMPYRA", "dalfampridine Extended Release Tablets", "CLOSED"], "modifyDate": "2019-07-08T09:04:35Z", "dkAbstract": "CLOSED", "agencyId": "FDA", "program": "CDER", "shortTitle": "Request the Food and Drug Administration carefully consider the sufficiency of the applicants identification and qualification of potentially genotoxic impurities in reviewing any ANDA.", "subType2": null, "title": "Request the Food and Drug Administration carefully consider the sufficiency of the identification and qualification of potentially genotoxic impurities in reviewing any ANDA referencing AMPYRA (dalfampridine) Extended Release Tablets. CLOSED", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2016-7417", "subType": null, "category": null, "field2": "CLOSED", "effectiveDate": null, "objectId": "0b0000648243b5da"} single_get

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