id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2024-P-2778-0013,FDA,FDA-2024-P-2778,"Final Response Letter from FDA CDER to Pharmobedient Consulting, LLC",Other,Denial of Petition,2024-12-26T05:00:00Z,2024,12,2024-12-26T05:00:00Z,,2024-12-26T17:30:38Z,,0,0,090000648688c866 FDA-2024-P-2778-0012,FDA,FDA-2024-P-2778,Completeness Assessment Correspondence,Other,Assessment Document or Analysis,2024-07-10T04:00:00Z,2024,7,2024-07-10T04:00:00Z,,2024-07-10T18:54:18Z,,0,0,09000064865e6919 FDA-2024-P-2778-0010,FDA,FDA-2024-P-2778,Attachment 4 - Draft Guidance on Chlorzoxazone,Supporting & Related Material,Background Material,2024-07-01T04:00:00Z,2024,7,,,2024-07-01T17:47:08Z,,0,0,09000064865d5493 FDA-2024-P-2778-0008,FDA,FDA-2024-P-2778,Attachment 1 - Orange Book for PARAFON FORTE DSC,Supporting & Related Material,Background Material,2024-07-01T04:00:00Z,2024,7,,,2024-07-01T17:46:59Z,,0,0,09000064865d5491 FDA-2024-P-2778-0009,FDA,FDA-2024-P-2778,Attachment 2 - RS under ANDA 089859 Revised 7 2019,Supporting & Related Material,Background Material,2024-07-01T04:00:00Z,2024,7,,,2024-07-01T17:47:03Z,,0,0,09000064865d5492 FDA-2024-P-2778-0011,FDA,FDA-2024-P-2778,Attachment 5 - Chlorzoxazone Orally Disintegrating Tablets,Supporting & Related Material,Background Material,2024-07-01T04:00:00Z,2024,7,,,2024-07-01T17:47:14Z,,0,0,09000064865d5494 FDA-2024-P-2778-0007,FDA,FDA-2024-P-2778,Suitability Petition Amendment from Pharmobedient Consulting LLC,Other,Amendment,2024-07-01T04:00:00Z,2024,7,2024-07-01T04:00:00Z,,2024-07-01T17:46:52Z,,0,0,09000064865d5630 FDA-2024-P-2778-0002,FDA,FDA-2024-P-2778,"Acknowledgment Letter from FDA DMS to Pharmobedient Consulting, LLC",Other,Acknowledgement Letter/Receipt,2024-06-11T04:00:00Z,2024,6,2024-06-11T04:00:00Z,,2024-06-11T14:51:05Z,,0,0,09000064865a7a6e FDA-2024-P-2778-0006,FDA,FDA-2024-P-2778,Attachment 4 - FDA BE guidance PSG_011529,Supporting & Related Material,Background Material,2024-06-11T04:00:00Z,2024,6,,,2024-06-11T14:51:53Z,,0,0,09000064865a7dd5 FDA-2024-P-2778-0005,FDA,FDA-2024-P-2778,Attachment 3 - Chloroxazone PI-ODT Revision-06.07.24,Supporting & Related Material,Background Material,2024-06-11T04:00:00Z,2024,6,,,2024-06-11T14:51:38Z,,0,0,09000064865a7dd3 FDA-2024-P-2778-0004,FDA,FDA-2024-P-2778,Attachment 2 - RS Labeling,Supporting & Related Material,Background Material,2024-06-11T04:00:00Z,2024,6,,,2024-06-11T14:51:29Z,,0,0,09000064865a7dd2 FDA-2024-P-2778-0001,FDA,FDA-2024-P-2778,"Suitability Petition from Pharmobedient Consulting, LLC",Other,Petition(s),2024-06-11T04:00:00Z,2024,6,2024-06-11T04:00:00Z,,2024-12-26T15:42:08Z,,0,0,09000064865a7a6d FDA-2024-P-2778-0003,FDA,FDA-2024-P-2778,Attachment 1 -Orange Book - Paraforn Forte DSC,Supporting & Related Material,Background Material,2024-06-11T04:00:00Z,2024,6,,,2024-06-11T14:51:19Z,,0,0,09000064865a7dcd