dockets: FDA-2026-P-2144

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-2026-P-2144 FDA Requests that the FDA declare that the drug products Lamotrigine Tablets, 12.5 mg (unscored) and 75 mg (scored or unscored), are suitable for consideration in an Abbreviated New Drug Application. Nonrulemaking 2026-03-19T22:06:46Z 0b000064b91e2b4c         ["CDER", "Suitability Petition", "Hyman Phelps and McNamara PC", "declare", "that the drug products Lamotrigine Tablets", "12 5 mg unscored", "and 75 mg scored or unscored", "are suitable for consideration in an", "Abbreviated New Drug Application", "OPEN"] CDER Requests that the FDA declare that the drug products Lamotrigine Tablets, 12.5 mg (unscored) and 75 mg (scored or unscored), are suitable for consideration in an ANDA.     {"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": "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", "Hyman Phelps and McNamara PC", "declare", "that the drug products Lamotrigine Tablets", "12 5 mg unscored", "and 75 mg scored or unscored", "are suitable for consideration in an", "Abbreviated New Drug Application", "OPEN"], "modifyDate": "2026-03-19T22:06:46Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests that the FDA declare that the drug products Lamotrigine Tablets, 12.5 mg (unscored) and 75 mg (scored or unscored), are suitable for consideration in an ANDA.", "subType2": null, "title": "Requests that the FDA declare that the drug products Lamotrigine Tablets, 12.5 mg (unscored) and 75 mg (scored or unscored), are suitable for consideration 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": "OPEN", "effectiveDate": null, "objectId": "0b000064b91e2b4c"} single_get

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