dockets: FDA-2026-P-4112

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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-4112 FDA Requests that the FDA take the following actions: 1. Rescind FDAs decision to file Ciplas section 505(b)(2) application for an apparent duplicate of DESCOVY; and 2. Refuse to grant Ciplas product an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant Nonrulemaking 2026-04-21T12:35:42Z 0b000064b92832a2   Open     ["CDER", "Citizen Petition", "Gilead Sciences, Inc.", "Requests that the FDA take the following actions", "1. Rescind FDA's decision to file Cipla's", "section 505(b)(2) application for an apparent", "duplicate of DESCOVY; and", "2. Refuse to grant Cipla's product an", "A-rating reflecting a determination of", "therapeutic equivalence, should such a", "determination become relevant", "Open"] CDER Requests that the FDA take the following actions: 1. Rescind FDAs decision to file Ciplas section 505(b)(2) application for an apparent duplicate of DESCOVY; and 2. Refuse to grant Cipla’s product     {"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", "Citizen Petition", "Gilead Sciences, Inc.", "Requests that the FDA take the following actions", "1. Rescind FDA's decision to file Cipla's", "section 505(b)(2) application for an apparent", "duplicate of DESCOVY; and", "2. Refuse to grant Cipla's product an", "A-rating reflecting a determination of", "therapeutic equivalence, should such a", "determination become relevant", "Open"], "modifyDate": "2026-04-21T12:35:42Z", "dkAbstract": "Open", "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests that the FDA take the following actions: 1. Rescind FDAs decision to file Ciplas section 505(b)(2) application for an apparent duplicate of DESCOVY; and 2. Refuse to grant Cipla\u2019s product", "subType2": null, "title": "Requests that the FDA take the following actions: 1. Rescind FDAs decision to file Ciplas section 505(b)(2) application for an apparent duplicate of DESCOVY; and 2. Refuse to grant Ciplas product an A-rating reflecting a determination of therapeutic equivalence, should such a determination become relevant", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b000064b92832a2"} single_get

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