dockets: FDA-2017-P-7031

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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-2017-P-7031 FDA Requests that the FDA determnine a new Reference Standard Drug (RS) for Generic Drug Product for Thiamine Hydrochloride Injection 100 m/g ml vial, NDA N080556 for listing in the Approved Drug Products with Therapeutics Equivalence Evaluations (Orange Book). Nonrulemaking 2017-12-29T12:34:40Z 0b00006482d83879         ["Citizen Petition", "CDER", "determnine a new Reference Standard Drug (RS)", "Generic Drug Product for", "for Thiamine Hydrochloride Injection 100 m/g ml", "vial, NDA N080556 for listing", "Approved Drug Products with Therapeutics", "Equivalence Evaluations (Orange Book)", "OPEN"] CDER Requests that the FDA determnine a new Reference Standard Drug (RS) for Generic Drug Product for Thiamine Hydrochloride Injection 100 m/g ml vial, NDA N080556 for listing in the Orange Book).     {"displayProperties": [{"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": ["Citizen Petition", "CDER", "determnine a new Reference Standard Drug (RS)", "Generic Drug Product for", "for Thiamine Hydrochloride Injection 100 m/g ml", "vial, NDA N080556 for listing", "Approved Drug Products with Therapeutics", "Equivalence Evaluations (Orange Book)", "OPEN"], "modifyDate": "2017-12-29T12:34:40Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests that the FDA determnine a new Reference Standard Drug (RS) for Generic Drug Product for Thiamine Hydrochloride Injection 100 m/g ml vial, NDA N080556 for listing in the Orange Book).", "subType2": null, "title": "Requests that the FDA determnine a new Reference Standard Drug (RS) for Generic Drug Product for Thiamine Hydrochloride Injection 100 m/g ml vial, NDA N080556 for listing in the Approved Drug Products with Therapeutics Equivalence Evaluations (Orange Book).", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b00006482d83879"} single_get

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