dockets: FDA-2008-P-0343

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-2008-P-0343 FDA Refrain from Approving Any Abbreviated New Drug Application (ANDA) for Repaglinide That Omits Crucial Information on Metformin Combination Therapy, Which is Protected by Patent & Currently Appears in the Labeling of the Innovator Product, PRANDIN-CLOSED Nonrulemaking 2022-01-05T01:03:16Z 0b0000648061d1ff   June 16, 2009 - CLOSED     ["niddm", "CDER", "77-751", "prandin", "mellitus", "diabetes", "repaglinide", "hyperglycemia", "CLOSED"] CDER       {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"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"}], "keywords": ["niddm", "CDER", "77-751", "prandin", "mellitus", "diabetes", "repaglinide", "hyperglycemia", "CLOSED"], "modifyDate": "2022-01-05T01:03:16Z", "dkAbstract": "June 16, 2009 - CLOSED", "agencyId": "FDA", "program": "CDER", "shortTitle": null, "subType2": null, "title": "Refrain from Approving Any Abbreviated New Drug Application (ANDA) for Repaglinide That Omits Crucial Information on Metformin Combination Therapy, Which is Protected by Patent & Currently Appears in the Labeling of the Innovator Product, PRANDIN-CLOSED", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "CLOSED", "effectiveDate": null, "objectId": "0b0000648061d1ff"} single_get

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