dockets: FDA-2007-D-0369

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-2007-D-0369 FDA Industry Describing Product-Specific Bioequivalence Recommendations Nonrulemaking 2026-06-11T14:29:42Z 0b0000648042bb86         ["Specific Products", "Product-Specific Bioequivalence", "Draft Guidances", "cder", "open", "Bioequivalence Recommendations for Risperidone", "Xiaoqiu Tang", "Risperdal Consta Long-Acting Injection", "BE", "generic risperidone injection", "Risperdal Consta", "ANDA", "NDA", "2015-197", "2015-298", "Bioequivalence Recommendations for Progesterone", "Draft Guidance for Industry", "Availability", "2015-1246", "2016-467", "2016-483", "2016-469", "2016-1029", "2017-125"] CDER Industry Describing Product-Specific Bioequivalence Recommendations     {"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": "legacyId", "label": "Legacy ID", "tooltip": "A pre-FDMS agency specific identifier migrated from a legacy system."}, {"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": ["Specific Products", "Product-Specific Bioequivalence", "Draft Guidances", "cder", "open", "Bioequivalence Recommendations for Risperidone", "Xiaoqiu Tang", "Risperdal Consta Long-Acting Injection", "BE", "generic risperidone injection", "Risperdal Consta", "ANDA", "NDA", "2015-197", "2015-298", "Bioequivalence Recommendations for Progesterone", "Draft Guidance for Industry", "Availability", "2015-1246", "2016-467", "2016-483", "2016-469", "2016-1029", "2017-125"], "modifyDate": "2026-06-11T14:29:42Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "Industry Describing Product-Specific Bioequivalence Recommendations", "subType2": null, "title": "Industry Describing Product-Specific Bioequivalence Recommendations", "generic": "D", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2007D-0168", "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b0000648042bb86"} single_get

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