dockets: FDA-2025-P-2077

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 attrs_raw attr_source
FDA-2025-P-2077 FDA Requests that the FDA confirm that Fluoxetine Capsules 15 mg and 30 mg is suitable for submission in an Abbreviated New Drug Application. Nonrulemaking 2025-12-31T14:22:07Z 0b000064b8e4ac3e   CLOSED     ["CDER", "Suitability Petition", "Premier Research", "confirm that Fluoxetine Capsules", "15 mg and 30 mg is suitable for submission in an", "Abbreviated New Drug Application", "CLOSED"] CDER Requests that the FDA confirm that Fluoxetine Capsules 15 mg and 30 mg is suitable for submission in an Abbreviated New Drug Application.   {"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"}, {"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", "Suitability Petition", "Premier Research", "confirm that Fluoxetine Capsules", "15 mg and 30 mg is suitable for submission in an", "Abbreviated New Drug Application", "CLOSED"], "modifyDate": "2025-12-31T14:22:07Z", "dkAbstract": "CLOSED", "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests that the FDA confirm that Fluoxetine Capsules 15 mg and 30 mg is suitable for submission in an Abbreviated New Drug Application.", "subType2": null, "title": "Requests that the FDA confirm that Fluoxetine Capsules 15 mg and 30 mg is suitable for submission in an Abbreviated New Drug Application.", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "CLOSED", "effectiveDate": null, "objectId": "0b000064b8e4ac3e"} single_get

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