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withdrawn,object_id FDA-2025-P-2611-0007,FDA,FDA-2025-P-2611,Final Response Letter from FDA CDER to Apozeal Pharmaceuticals Inc.,Other,Denial of Petition,2025-12-30T05:00:00Z,2025,12,2025-12-30T05:00:00Z,,2025-12-30T20:57:44Z,,0,0,09000064b910c0e1 FDA-2025-P-2611-0006,FDA,FDA-2025-P-2611,Completeness Assessment Correspondence,Other,Assessment Document or Analysis,2025-08-06T04:00:00Z,2025,8,2025-08-06T04:00:00Z,,2025-08-06T21:30:01Z,,0,0,09000064b8ee4bb6 FDA-2025-P-2611-0003,FDA,FDA-2025-P-2611,Attachment 1 - Information regarding RLD from current Orange Book,Supporting & Related Material,Background Material,2025-07-24T04:00:00Z,2025,7,,,2025-07-24T21:00:35Z,,0,0,09000064b8e9ba6a FDA-2025-P-2611-0004,FDA,FDA-2025-P-2611,Attachment 2 - Comparison of Proposed Outsert against RLD Outsert,Supporting & Related Material,Background Material,2025-07-24T04:00:00Z,2025,7,,,2025-07-24T21:00:39Z,,0,0,09000064b8e9ba6b FDA-2025-P-2611-0005,FDA,FDA-2025-P-2611,Attachment 3 - Labeling from current RLD,Supporting & Related Material,Background Material,2025-07-24T04:00:00Z,2025,7,,,2025-07-24T21:00:46Z,,0,0,09000064b8e9ba6c FDA-2025-P-2611-0002,FDA,FDA-2025-P-2611,Acknowledgement Letter from FDA DMB to Apozeal Pharmaceuticals Inc.,Other,Acknowledgement Letter/Receipt,2025-07-24T04:00:00Z,2025,7,2025-07-24T04:00:00Z,,2025-07-24T20:59:56Z,,0,0,09000064b8e9a0ce FDA-2025-P-2611-0001,FDA,FDA-2025-P-2611,Suitability Petition from Apozeal Pharmaceuticals Inc.,Other,Petition(s),2025-07-24T04:00:00Z,2025,7,2025-07-24T04:00:00Z,,2025-12-30T20:14:41Z,,0,0,09000064b8e9a0cd