dockets: FDA-2005-P-0134

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-2005-P-0134 FDA ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/5 mL - CLOSED Nonrulemaking 2021-09-01T01:01:16Z 0b0000648043fe18   Docket Status: CLOSED per 12/10/2008 Petition Denial (LB)     ["oral", "USP", "ANDA", "CDER", "sulfate", "solution", "atropine", "hydrochloride", "diphenoxylate", "5 mg/ 0.05 mg/ mL", "CLOSED"] CDER ANDA suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/ 5 mL.     {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"name": "legacyId", "label": "Legacy ID", "tooltip": "A pre-FDMS agency specific identifier migrated from a legacy system."}, {"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": ["oral", "USP", "ANDA", "CDER", "sulfate", "solution", "atropine", "hydrochloride", "diphenoxylate", "5 mg/ 0.05 mg/ mL", "CLOSED"], "modifyDate": "2021-09-01T01:01:16Z", "dkAbstract": "Docket Status: CLOSED per 12/10/2008 Petition Denial (LB)", "agencyId": "FDA", "program": "CDER", "shortTitle": "ANDA suitability for Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/ 5 mL.", "subType2": null, "title": "ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/5 mL - CLOSED", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2005P-0162", "subType": null, "category": null, "field2": "CLOSED", "effectiveDate": null, "objectId": "0b0000648043fe18"} single_get

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