dockets: FDA-2026-P-5994

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-5994 FDA Requests that FDA declare that Rosuvastatin Calcium Tablets, 7.5 mg, 15 mg, 25 mg, 30 mg, and 35 mg, are suitable for submission as an ANDA. Nonrulemaking 2026-06-08T17:56:40Z 0b000064b92f2eee   OPEN     ["CDER", "Suitability Petition", "Hyman, Phelps & McNamara, P.C.", "declare that Rosuvastatin Calcium Tablets", "are suitable for submission as an ANDA", "Approved Drug Products with", "Therapeutic Equivalence Evaluations", "Orange Book", "Reference Listed Drug (\u201cRLD\u201d)", "AstraZeneca UK Limited\u2019s CRESTOR", "New Drug Application (\u201cNDA\u201d) 021366", "5 mg, 10 mg, 20 mg, and 40 mg strengths", "Open"] CDER Requests that FDA declare that Rosuvastatin Calcium Tablets, 7.5 mg, 15 mg, 25 mg, 30 mg, and 35 mg, are suitable for submission as an ANDA.     {"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", "Hyman, Phelps & McNamara, P.C.", "declare that Rosuvastatin Calcium Tablets", "are suitable for submission as an ANDA", "Approved Drug Products with", "Therapeutic Equivalence Evaluations", "Orange Book", "Reference Listed Drug (\u201cRLD\u201d)", "AstraZeneca UK Limited\u2019s CRESTOR", "New Drug Application (\u201cNDA\u201d) 021366", "5 mg, 10 mg, 20 mg, and 40 mg strengths", "Open"], "modifyDate": "2026-06-08T17:56:40Z", "dkAbstract": "OPEN", "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests that FDA declare that Rosuvastatin Calcium Tablets, 7.5 mg, 15 mg, 25 mg, 30 mg, and 35 mg, are suitable for submission as an ANDA.", "subType2": null, "title": "Requests that FDA declare that Rosuvastatin Calcium Tablets, 7.5 mg, 15 mg, 25 mg, 30 mg, and 35 mg, are suitable for submission as an ANDA.", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b000064b92f2eee"} single_get

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