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withdrawn,object_id FDA-2025-P-2524-0005,FDA,FDA-2025-P-2524,"Response Letter from FDA CDER to Novitium Pharma, LLC",Other,Approval,2026-04-14T04:00:00Z,2026,4,2026-04-14T04:00:00Z,,2026-04-14T15:22:53Z,,0,0,09000064b927a1e2 FDA-2025-P-2524-0004,FDA,FDA-2025-P-2524,"Determination That BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2026-04-13T04:00:00Z,2026,4,2026-04-13T04:00:00Z,,2026-04-13T21:09:10Z,2026-07059,0,0,09000064b9272b56 FDA-2025-P-2524-0003,FDA,FDA-2025-P-2524,"Interim Response Letter from FDA CDER to Novitium Pharma, LLC",Other,Response(s),2026-01-14T05:00:00Z,2026,1,2026-01-14T05:00:00Z,,2026-01-15T00:56:13Z,,0,0,09000064b913f358 FDA-2025-P-2524-0002,FDA,FDA-2025-P-2524,Acknowledgment Letter from FDA DMB to Novitium Pharma LLC,Other,Acknowledgement Letter/Receipt,2025-07-21T04:00:00Z,2025,7,2025-07-21T04:00:00Z,,2025-07-22T00:51:26Z,,0,0,09000064b8e8e94a FDA-2025-P-2524-0001,FDA,FDA-2025-P-2524,Citizen Petition from Novitium Pharma LLC,Other,Citizen Petition,2025-07-21T04:00:00Z,2025,7,2025-07-21T04:00:00Z,,2025-07-22T00:49:56Z,,1,0,09000064b8e8e0a5