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withdrawn,object_id FDA-2024-P-2932-0007,FDA,FDA-2024-P-2932,Final Response Letter from FDA CDER to Newcastle Bioscience LLC,Other,Denial of Petition,2024-12-27T05:00:00Z,2024,12,2024-12-27T05:00:00Z,,2024-12-27T19:50:55Z,,0,0,090000648688c861 FDA-2024-P-2932-0006,FDA,FDA-2024-P-2932,Completeness Assessment Correspondence,Other,Assessment Document or Analysis,2024-07-09T04:00:00Z,2024,7,2024-07-09T04:00:00Z,,2024-07-09T11:11:53Z,,0,0,09000064865dfda2 FDA-2024-P-2932-0005,FDA,FDA-2024-P-2932,Attachment 3 - Approved Labeling for Reference Listed Drug Lipitor,Supporting & Related Material,Background Material,2024-06-20T04:00:00Z,2024,6,,,2024-06-20T20:21:37Z,,0,0,09000064865c139b FDA-2024-P-2932-0002,FDA,FDA-2024-P-2932,Acknowledgement Letter from FDA DMS to Newcastle Bioscience LLC,Other,Acknowledgement Letter/Receipt,2024-06-20T04:00:00Z,2024,6,2024-06-20T04:00:00Z,,2024-06-20T20:21:23Z,,0,0,09000064865c165d FDA-2024-P-2932-0004,FDA,FDA-2024-P-2932,Attachment 2 - Draft Insert for Proposed Product,Supporting & Related Material,Background Material,2024-06-20T04:00:00Z,2024,6,,,2024-06-20T20:21:32Z,,0,0,09000064865c139a FDA-2024-P-2932-0003,FDA,FDA-2024-P-2932,Attachment 1 - Approved Drug Products with Therapeutic Equivalence Evaluations,Supporting & Related Material,Background Material,2024-06-20T04:00:00Z,2024,6,,,2024-06-20T20:21:28Z,,0,0,09000064865c1588 FDA-2024-P-2932-0001,FDA,FDA-2024-P-2932,Suitability Petition from Newcastle Bioscience LLC,Other,Petition(s),2024-06-20T04:00:00Z,2024,6,2024-06-20T04:00:00Z,,2024-12-26T15:31:03Z,,0,0,09000064865c1657