dockets: FDA-2026-P-4574

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-4574 FDA Requests that the FDA determine whether the original formulation submitted for the Reference Listed Drng (RLD), ISTURSIA (osilodrostat) tablets 10 mg (Product Number 003); New Drug Application (NDA) 212801, held by RECORDATI RARE DISEASES INC has been voluntarily withdrawn from the commercial market or withdrawn from sale for reasons of safety or eff Nonrulemaking 2026-04-24T19:08:49Z 0b000064b92a8081   OPEN     ["CDER", "Citizen Petition", "Annora Pharma Private Limited", "determine whether the original", "formulation submitted for the", "Reference Listed Drng (RLD), ISTURSIA", "(osilodrostat) tablets 10 mg", "(Product Number 003)", "New Drug Application (NDA) 212801", "held by RECORDATI RARE DISEASES INC", "has been voluntarily withdrawn from", "the commercial market or withdrawn", "from sale for reasons of safety or efficacy", "OPEN"] CDER Requests that the FDA determine whether the original formulation submitted for the Reference Listed Drng (RLD), ISTURSIA (osilodrostat) tablets 10 mg (Product Number 003); New Drug Application (NDA) 2     {"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", "Annora Pharma Private Limited", "determine whether the original", "formulation submitted for the", "Reference Listed Drng (RLD), ISTURSIA", "(osilodrostat) tablets 10 mg", "(Product Number 003)", "New Drug Application (NDA) 212801", "held by RECORDATI RARE DISEASES INC", "has been voluntarily withdrawn from", "the commercial market or withdrawn", "from sale for reasons of safety or efficacy", "OPEN"], "modifyDate": "2026-04-24T19:08:49Z", "dkAbstract": "OPEN", "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests that the FDA determine whether the original formulation submitted for the Reference Listed Drng (RLD), ISTURSIA (osilodrostat) tablets 10 mg (Product Number 003); New Drug Application (NDA) 2", "subType2": null, "title": "Requests that the FDA determine whether the original formulation submitted for the Reference Listed Drng (RLD), ISTURSIA (osilodrostat) tablets 10 mg (Product Number 003); New Drug Application (NDA) 212801, held by RECORDATI RARE DISEASES INC has been voluntarily withdrawn from the commercial market or withdrawn from sale for reasons of safety or eff", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b000064b92a8081"} single_get

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