dockets: FDA-2021-P-0567

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-2021-P-0567 FDA Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an Abbreviated New Drug Application Nonrulemaking 2026-06-10T18:15:38Z 0b00006484b93f5d   CLOSED     ["CLOSED", "an ANDA", "suitable for submission in", "1 mg/mL is", "Solifenacin Oral Solution", "declare that the drug product", "Liqmeds Limited, UK", "M A Pharmaceutical Consulting Inc", "CDER", "Suitability Petition"] CDER Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in 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": ["CLOSED", "an ANDA", "suitable for submission in", "1 mg/mL is", "Solifenacin Oral Solution", "declare that the drug product", "Liqmeds Limited, UK", "M A Pharmaceutical Consulting Inc", "CDER", "Suitability Petition"], "modifyDate": "2026-06-10T18:15:38Z", "dkAbstract": "CLOSED", "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an ANDA", "subType2": null, "title": "Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL 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": "0b00006484b93f5d"} single_get

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