dockets: FDA-2008-P-0368

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-2008-P-0368 FDA Refuse to Approve Any Application for An Ophthalmic Drug Product Containing Bromfenac Sodium Submitted Under Section 505(j) or 505(b) of the Federal Food, Drug & Cosmetic Act Unless Specific Standards Are Satisfied-CLOSED Nonrulemaking 2022-01-05T01:03:19Z 0b0000648063c5cb   Status: CLOSED Closed per letter of 5/11/2011     ["CDER", "NDA 21-664", "Xibrom 0.09%", "ISTA Pharmaceuticals", "bromfenac ophthalmic solution", "CLOSED"] CDER       {"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"}], "keywords": ["CDER", "NDA 21-664", "Xibrom 0.09%", "ISTA Pharmaceuticals", "bromfenac ophthalmic solution", "CLOSED"], "modifyDate": "2022-01-05T01:03:19Z", "dkAbstract": "Status: CLOSED\r\nClosed per letter of 5/11/2011", "agencyId": "FDA", "program": "CDER", "shortTitle": null, "subType2": null, "title": "Refuse to Approve Any Application for An Ophthalmic Drug Product Containing Bromfenac Sodium Submitted Under Section 505(j) or 505(b) of the Federal Food, Drug & Cosmetic Act Unless Specific Standards Are Satisfied-CLOSED", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "CLOSED", "effectiveDate": null, "objectId": "0b0000648063c5cb"} single_get

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