dockets: FDA-2016-P-1962

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-2016-P-1962 FDA Request FDA refuse to receive and refuse to approve an ANDA from a generic drug manufacturer seeking approval to market a generic version of LINZESS Capsules unless and until the generic drug manufacturer demonstrate bioequivalence to LINZESS and conduct enhanced analytical and stability testing. Nonrulemaking 2018-12-31T17:07:39Z 0b0000648209432d   OPEN     ["Citizen Petition", "2016-4107", "Allergan plc", "LINZESS", "CDRH", "ANDA", "Irritable Bowel Syndrome with Constipation", "IBSC", "Hyman, Phelps & McNamara, P.C.", "OPEN"] CDER Request FDA refuse to receive and approve ANDAs for generic versions of LINZESS (Linaclolide) capsules unless certain requirements are met     {"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": ["Citizen Petition", "2016-4107", "Allergan plc", "LINZESS", "CDRH", "ANDA", "Irritable Bowel Syndrome with Constipation", "IBSC", "Hyman, Phelps & McNamara, P.C.", "OPEN"], "modifyDate": "2018-12-31T17:07:39Z", "dkAbstract": "OPEN", "agencyId": "FDA", "program": "CDER", "shortTitle": "Request FDA refuse to receive and approve ANDAs for generic versions of LINZESS (Linaclolide) capsules unless certain requirements are met", "subType2": null, "title": "Request FDA refuse to receive and refuse to approve an ANDA from a generic drug manufacturer seeking approval to market a generic version of LINZESS Capsules unless and until the generic drug manufacturer demonstrate bioequivalence to LINZESS and conduct enhanced analytical and stability testing.", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2016-4107", "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b0000648209432d"} single_get

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