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withdrawn,object_id FDA-2026-P-2144-0003,FDA,FDA-2026-P-2144,Attachment 1,Supporting & Related Material,Background Material,2026-02-27T05:00:00Z,2026,2,,,2026-02-27T22:06:13Z,,0,0,09000064b91e2fca FDA-2026-P-2144-0005,FDA,FDA-2026-P-2144,Attachment 3,Supporting & Related Material,Background Material,2026-02-27T05:00:00Z,2026,2,,,2026-02-27T22:06:19Z,,0,0,09000064b91e2fcc FDA-2026-P-1300-0006,FDA,FDA-2026-P-1300,"Attachment 1 - RLD BELSOMRA® (Suvorexant) Tablets 5 mg, 10 mg, 15 mg and 20 mg Package Insert",Supporting & Related Material,Background Material,2026-02-27T05:00:00Z,2026,2,,,2026-02-27T23:32:57Z,,0,0,09000064b91e3e19 FDA-2026-P-1300-0007,FDA,FDA-2026-P-1300,"Attachment 2 - RLD BELSOMRA® (Suvorexant) Tablets 5 mg, 10 mg, 15 mg and 20 mg Approval Letter",Supporting & Related Material,Background Material,2026-02-27T05:00:00Z,2026,2,,,2026-02-27T23:33:00Z,,0,0,09000064b91e3e1a FDA-2026-P-2144-0004,FDA,FDA-2026-P-2144,Attachment 2,Supporting & Related Material,Background Material,2026-02-27T05:00:00Z,2026,2,,,2026-02-27T22:06:16Z,,0,0,09000064b91e2fcb FDA-2026-P-2004-0004,FDA,FDA-2026-P-2004,Attachment 2,Supporting & Related Material,Background Material,2026-02-25T05:00:00Z,2026,2,,,2026-02-25T23:22:03Z,,0,0,09000064b91dab5d FDA-2026-P-2004-0005,FDA,FDA-2026-P-2004,Attachment 3,Supporting & Related Material,Background Material,2026-02-25T05:00:00Z,2026,2,,,2026-02-25T23:22:06Z,,0,0,09000064b91dab5e FDA-2026-P-2004-0003,FDA,FDA-2026-P-2004,Attachment 1,Supporting & Related Material,Background Material,2026-02-25T05:00:00Z,2026,2,,,2026-02-25T23:22:01Z,,0,0,09000064b91dab5c FDA-2025-P-4282-0172,FDA,FDA-2025-P-4282,Reference 27 - Large - Violence in first-episode psychosis A systematic review and meta-analysis,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:10Z,,0,0,09000064b91d3d7f FDA-2025-P-4282-0154,FDA,FDA-2025-P-4282,Reference 9 - Chalasani - Clozapine Impact on Clinical Outcomes and Aggression in Severely Ill Adolescents with Childhood-Onset Schizophrenia,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:18Z,,0,0,09000064b91d3d6d FDA-2025-P-4282-0160,FDA,FDA-2025-P-4282,Reference 15 - di Giacomo et al - Prescribing Patterns of Psychotropic Drugs and Risk of Violent Behavior,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:36Z,,0,0,09000064b91d3d73 FDA-2025-P-4282-0164,FDA,FDA-2025-P-4282,Reference 19 - Fazel et al - Schizophrenia and Violence Systematic Review and Meta-Analysis,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:49Z,,0,0,09000064b91d3d77 FDA-2025-P-4282-0167,FDA,FDA-2025-P-4282,Reference 22 - Galletly - Royal Australian and New Zealand College of Psychiatrists Clinical Practice Guidelines,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:57Z,,0,0,09000064b91d3d7a FDA-2025-P-4282-0148,FDA,FDA-2025-P-4282,Reference 4 - Bitter - Effectiveness of Clozapine Olanzapine Quetiapine Risperidone and Haloperidol Monotherapy,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:42:58Z,,0,0,09000064b91d0f90 FDA-2025-P-4282-0151,FDA,FDA-2025-P-4282,Reference 7 - Cavaliere - Anti-Aggressive Effects of Clozapine in Involuntarily Committed Black Patients with Severe Mental Illness,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:09Z,,0,0,09000064b91d0f93 FDA-2025-P-4282-0178,FDA,FDA-2025-P-4282,Reference 33 - Sariaslan - Associations between individual antipsychotics and the Risk of Arrests and Convictions of Violent and Other Crime,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:30Z,,0,0,09000064b91d3d85 FDA-2025-P-4282-0150,FDA,FDA-2025-P-4282,Reference 6 - Buckley - Violence and Schizophrenia Clozapine as a Specific Antiaggressive Agent,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:05Z,,0,0,09000064b91d0f92 FDA-2025-P-4282-0156,FDA,FDA-2025-P-4282,Reference 11 - Citrome - Specific Anti-hostility Effects of Atypical Antipsychotics in Persons with Schizophrenia,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:24Z,,0,0,09000064b91d3d6f FDA-2025-P-4282-0158,FDA,FDA-2025-P-4282,Reference 13 - de Domenico - The effect of clozapine of aggressive behaviour in patients with chronic schizophrenia,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:30Z,,0,0,09000064b91d3d71 FDA-2025-P-4282-0169,FDA,FDA-2025-P-4282,Reference 24 - Herman - Clinical Response to Clozapine Treatment of 11 Chronic Patients in a State Psychiatric Hospital,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:02Z,,0,0,09000064b91d3d7c FDA-2025-P-4282-0155,FDA,FDA-2025-P-4282,Reference 10 - Chiles - Effects of Clozapine on Use of Seclusion and Restraint at a State Hospital,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:21Z,,0,0,09000064b91d3d6e FDA-2025-P-4282-0159,FDA,FDA-2025-P-4282,Reference 14 - Dennis - Clozapine Therapy in a State Hospital,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:33Z,,0,0,09000064b91d3d72 FDA-2025-P-4282-0163,FDA,FDA-2025-P-4282,Reference 18 - Fazel Grann - The Population Impact of Severe Mental Illness on Violent Crime,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:46Z,,0,0,09000064b91d3d76 FDA-2025-P-4282-0168,FDA,FDA-2025-P-4282,Reference 23 - Gammon - Clozapine Why Is It So Uniquely Effective in the Treatment ofa Range of Neuropsychiatric Disorders,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:00Z,,0,0,09000064b91d3d7b FDA-2025-P-4282-0182,FDA,FDA-2025-P-4282,Reference 37 - Wagner et al - Clozapine Optimization A Delphi Consensus Guideline From the Treatment Response and Resistance in Psychosis Working Group,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:42Z,,0,0,09000064b91d3d89 FDA-2025-P-4282-0152,FDA,FDA-2025-P-4282,Reference 8 - Clozapine Impact on Clinical Outcomes and Aggression in Severly Ill Adolescents with Childhood-Onset Schizophrenia,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:12Z,,0,0,09000064b91d3d6b FDA-2025-P-4282-0171,FDA,FDA-2025-P-4282,Reference 26 - Kranzler - Clozapine Its Impact on Aggressive Behavior Among Children and Adolescents with Schizophrenia,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:08Z,,0,0,09000064b91d3d7e FDA-2025-P-4282-0173,FDA,FDA-2025-P-4282,Reference 28 - Newman - Management of Aggression,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:13Z,,0,0,09000064b91d3d80 FDA-2025-P-4282-0175,FDA,FDA-2025-P-4282,Reference 30 - Potkin - Predicting Suicidal Risk in Schizophrenic and Schizoaffective Patients in a Prospective Two-Year Trial,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:19Z,,0,0,09000064b91d3d82 FDA-2025-P-4282-0179,FDA,FDA-2025-P-4282,Reference 34 - Shaheen - The Effect of Clozapine on Violence - Aggression in Adults with Mental Illness and Personality Disorders,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:33Z,,0,0,09000064b91d3d86 FDA-2025-P-4282-0181,FDA,FDA-2025-P-4282,Reference 36 - Volavka - Efficacy of Clozapine Olanzapine Risperidone and Haloperidol in Schizophrenia and Schizoaffective Disorder,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:39Z,,0,0,09000064b91d3d88 FDA-2025-P-4282-0146,FDA,FDA-2025-P-4282,Reference 2 - Barnes - Evidence-based Guidelines for the Pharmacological Treatment of Schizophrenia,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:42:51Z,,0,0,09000064b91d0f8e FDA-2025-P-4282-0176,FDA,FDA-2025-P-4282,Reference 31 - Rabinowitz - Effect of clozapine on physical and verbal aggression,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:23Z,,0,0,09000064b91d3d83 FDA-2025-P-4282-0166,FDA,FDA-2025-P-4282,Reference 21 - Frogley - A systematic review of the evidence of clozapines anti-aggressive effects,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:54Z,,0,0,09000064b91d3d79 FDA-2025-P-4282-0180,FDA,FDA-2025-P-4282,Reference 35 - Volavka - Atypical antipsychotics in the treatment of the persistently aggressive psychotic patient,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:36Z,,0,0,09000064b91d3d87 FDA-2025-P-4282-0177,FDA,FDA-2025-P-4282,Reference 32 - Reid - Internet Archive Interlibrary Loan Fulfillment,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:27Z,,0,0,09000064b91d3d84 FDA-2025-P-4282-0149,FDA,FDA-2025-P-4282,Reference 5 - Buchanan - The 2009 Schizophrenia PORT Psychopharmacological Treatment Recommendations and Summary Statements,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:01Z,,0,0,09000064b91d0f91 FDA-2025-P-4282-0153,FDA,FDA-2025-P-4282,Reference 8a - Chengappa - Clozapine Its impact on Aggressive Behavior Among Patients in a State Psychiatric Hospital,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:15Z,,0,0,09000064b91d3d6c FDA-2025-P-4282-0157,FDA,FDA-2025-P-4282,Reference 12 - Citrome - Effects of Clozapine Olanzapine Risperidone and Haloperidol on Hostility Among Patients with Schizophrenia,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:27Z,,0,0,09000064b91d3d70 FDA-2025-P-4282-0161,FDA,FDA-2025-P-4282,Reference 16 - Ebrahim - Patient Response to Clozapine in a Forensic Psychiatric Hospital,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:41Z,,0,0,09000064b91d3d74 FDA-2025-P-4282-0165,FDA,FDA-2025-P-4282,Reference 20 - Fazel et al - Violent crime suicide and premature mortality in patients with schizophrenia and related disorders,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:51Z,,0,0,09000064b91d3d78 FDA-2025-P-4282-0170,FDA,FDA-2025-P-4282,Reference 25 - Keepers - The American Psychiatric Association Practice Guideline for the Treatment of Patients with Schizophrenia,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:05Z,,0,0,09000064b91d3d7d FDA-2025-P-4282-0174,FDA,FDA-2025-P-4282,Reference 29 - Nolan - Aggression and psychopathology in treatment-resistant inpatients with schizophrenia and Schizoaffective Disorder,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:44:16Z,,0,0,09000064b91d3d81 FDA-2025-P-4282-0145,FDA,FDA-2025-P-4282,Reference 1 - Balbuena - Does Clozapine Promote Employability and Reduce Offending Among Mentally Disordered Offenders,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:42:48Z,,0,0,09000064b91d0f8d FDA-2025-P-4282-0147,FDA,FDA-2025-P-4282,Reference 3 - Bhavsar - Clozapine Treatment and Offending A Within-Subject Study of Patients With Psychotic Disorders in Sweden,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:42:54Z,,0,0,09000064b91d0f8f FDA-2025-P-4282-0162,FDA,FDA-2025-P-4282,Reference 17 - Faden - A systematic review of clozapine for aggression and violence in patients with schizophrenia or schizoaffective disorder,Supporting & Related Material,Background Material,2026-02-24T05:00:00Z,2026,2,,,2026-02-25T02:43:43Z,,0,0,09000064b91d3d75 FDA-2024-N-1939-0024,FDA,FDA-2024-N-1939,References List for Cottage Cheese Exemption Final Notice,Supporting & Related Material,Background Material,2026-02-20T05:00:00Z,2026,2,,,2026-02-20T20:07:25Z,,0,0,09000064b91c26ff FDA-2024-N-1939-0025,FDA,FDA-2024-N-1939,"Reference 1 - FDA and NCIMS, “Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipment (2019 Revision)”, 2019",Supporting & Related Material,Background Material,2026-02-20T05:00:00Z,2026,2,,,2026-02-20T20:10:06Z,,0,0,09000064b91c2701 FDA-2024-N-1939-0026,FDA,FDA-2024-N-1939,"Reference 2 - FDA and NCIMS, “Memorandum of Understanding Between the National Conference on Interstate Milk Shipments and the Food and Drug Administration”, 1977",Supporting & Related Material,Background Material,2026-02-20T05:00:00Z,2026,2,,,2026-02-20T20:11:46Z,,0,0,09000064b91c2702 FDA-2024-N-1939-0027,FDA,FDA-2024-N-1939,"Reference 3 - FDA, “Grade “A” Pasteurized Milk Ordinance (2019 Revision),” 2019",Supporting & Related Material,Background Material,2026-02-20T05:00:00Z,2026,2,,,2026-02-20T20:13:12Z,,0,0,09000064b91c2703 FDA-2024-N-1939-0028,FDA,FDA-2024-N-1939,"Reference 4 - FDA Memorandum, “2023 Revision of the Grade “A” Pasteurized Milk Ordinance (PMO),” M-I-24-02, August 9, 2024",Supporting & Related Material,Background Material,2026-02-20T05:00:00Z,2026,2,,,2026-02-20T20:14:35Z,,0,0,09000064b91c2704 FDA-2024-N-1939-0029,FDA,FDA-2024-N-1939,"Reference 5 - FDA, “Grade “A” Pasteurized Milk Ordinance (2023 Revision),” 2023",Supporting & Related Material,Background Material,2026-02-20T05:00:00Z,2026,2,,,2026-02-20T20:16:04Z,,0,0,09000064b91c2705 FDA-2026-P-1819-0004,FDA,FDA-2026-P-1819,Exhibit A,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T23:12:34Z,,0,0,09000064b91bf192 FDA-2026-P-1833-0004,FDA,FDA-2026-P-1833,Attachment 2 - Current Electronic Edition of the Approved Drug Products with Therapeutic Equivalence Evaluations - Tolmetin Sodium,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-20T00:31:03Z,,0,0,09000064b91bf195 FDA-2026-P-1790-0003,FDA,FDA-2026-P-1790,Attachment_1_Photographic_Evidence_Pediatric_Scald_Injury,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T18:16:18Z,,0,0,09000064b91b91c7 FDA-2026-P-1833-0003,FDA,FDA-2026-P-1833,Attachment 1 - Current Electronic Edition of the Approved Drug Products with Therapeutic Equivalence Evaluations,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-20T00:31:00Z,,0,0,09000064b91bf194 FDA-2026-P-1820-0003,FDA,FDA-2026-P-1820,Attachment 1 - Tolmetin Capsules - OB Page,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T22:23:47Z,,0,0,09000064b91c1073 FDA-2026-P-1820-0005,FDA,FDA-2026-P-1820,Attachment 3 - RS Approved Labeling,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T22:23:52Z,,0,0,09000064b91c107e FDA-2026-P-1792-0005,FDA,FDA-2026-P-1792,"Attachment 3 - Draft Package Insert Proposed for Pregabalin Extended-Release Tablets, 247.5 mg, 495 mg and 660 mg",Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T17:46:25Z,,0,0,09000064b91b9245 FDA-2026-P-1833-0005,FDA,FDA-2026-P-1833,Attachment 3 - Prescribing Information Tolmetin Sodium Capsules USP 400 mg,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-20T00:31:07Z,,0,0,09000064b91bf196 FDA-2026-P-1833-0006,FDA,FDA-2026-P-1833,Attachment 4 - Proposed labeling for Tolmetin Sodium Capsules 600 mg,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-20T00:31:10Z,,0,0,09000064b91bf197 FDA-2026-P-1820-0004,FDA,FDA-2026-P-1820,Attachment 2 - Tolmetin Tablets 200 mg - OB Page,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T22:23:50Z,,0,0,09000064b91c1076 FDA-2026-P-1792-0003,FDA,FDA-2026-P-1792,Attachment 1 - Copy of the relevant excerpt from the current electronic Edition of Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book),Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T17:46:12Z,,0,0,09000064b91b9243 FDA-2026-P-1792-0004,FDA,FDA-2026-P-1792,"Attachment 2 - Current Package Insert for LYRICA CE®, NDA#209501",Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T17:46:22Z,,0,0,09000064b91b9244 FDA-2026-P-1819-0003,FDA,FDA-2026-P-1819,Exhibit 1,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T23:12:29Z,,0,0,09000064b91bf191 FDA-2026-P-1819-0005,FDA,FDA-2026-P-1819,Exhibit B,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T23:12:38Z,,0,0,09000064b91bf193 FDA-2026-P-1820-0006,FDA,FDA-2026-P-1820,Attachment 4 - Proposed Labeling for Tolmetin Capsules 200 mg,Supporting & Related Material,Background Material,2026-02-19T05:00:00Z,2026,2,,,2026-02-19T22:23:54Z,,0,0,09000064b91c1080 FDA-2026-P-1794-0007,FDA,FDA-2026-P-1794,Attachment 5 Advances in Therapy,Supporting & Related Material,Background Material,2026-02-18T05:00:00Z,2026,2,,,2026-02-19T01:52:47Z,,0,0,09000064b91bb01b FDA-2026-P-1794-0004,FDA,FDA-2026-P-1794,Attachment 2 Current Package Insert for Xarelto,Supporting & Related Material,Background Material,2026-02-18T05:00:00Z,2026,2,,,2026-02-19T01:52:36Z,,0,0,09000064b91b9bfd FDA-2026-P-1794-0006,FDA,FDA-2026-P-1794,Attachment 4 Blood Advances,Supporting & Related Material,Background Material,2026-02-18T05:00:00Z,2026,2,,,2026-02-19T01:52:44Z,,0,0,09000064b91bb01a FDA-2026-P-1794-0005,FDA,FDA-2026-P-1794,Attachment 3 Proposed Package Insert Rivaroxaban ODT,Supporting & Related Material,Background Material,2026-02-18T05:00:00Z,2026,2,,,2026-02-19T01:52:40Z,,0,0,09000064b91b9bfe FDA-2026-P-1794-0003,FDA,FDA-2026-P-1794,Attachment 1 Copy of Current Orange Book Listing for RLD Xarelto,Supporting & Related Material,Background Material,2026-02-18T05:00:00Z,2026,2,,,2026-02-19T01:52:31Z,,0,0,09000064b91b9bfc FDA-2026-N-0302-0003,FDA,FDA-2026-N-0302,Reference 1 BHA RFI Prior Sanction Citizen Petition,Supporting & Related Material,Background Material,2026-02-11T05:00:00Z,2026,2,,,2026-02-11T19:21:26Z,,0,0,09000064b919eb26 FDA-2026-N-0302-0004,FDA,FDA-2026-N-0302,Reference 2 What We Eat in America 2021-2023 Food Categories,Supporting & Related Material,Background Material,2026-02-11T05:00:00Z,2026,2,,,2026-02-11T19:21:40Z,,0,0,09000064b919eb27 FDA-2026-P-1583-0007,FDA,FDA-2026-P-1583,Reference 4 - Second edition of guidelines for evaluating the efficacy of anthelmintics for dogs and cats,Supporting & Related Material,Background Material,2026-02-11T05:00:00Z,2026,2,,,2026-02-11T23:00:15Z,,0,0,09000064b91a3353 FDA-2026-P-1583-0004,FDA,FDA-2026-P-1583,Reference 1 - Pathogens in fleas collected from cats and dogs - distribution and prevalence in the UK,Supporting & Related Material,Background Material,2026-02-11T05:00:00Z,2026,2,,,2026-02-11T23:00:06Z,,0,0,09000064b91a3350 FDA-2026-P-1583-0006,FDA,FDA-2026-P-1583,Reference 3 - Analysis of Dipylidium caninum tapeworms from dogs and cats or their respective fleas,Supporting & Related Material,Background Material,2026-02-11T05:00:00Z,2026,2,,,2026-02-11T23:00:12Z,,0,0,09000064b91a3352 FDA-2026-P-1583-0005,FDA,FDA-2026-P-1583,Reference 2 - Occurence of Dipylidium caninum in fleas from client-owned cats and dogs in Europe using a new PCR detection assay,Supporting & Related Material,Background Material,2026-02-11T05:00:00Z,2026,2,,,2026-02-11T23:00:09Z,,0,0,09000064b91a3351 FDA-2026-N-0302-0002,FDA,FDA-2026-N-0302,Reference List for FDA-2026-N-0302,Supporting & Related Material,Background Material,2026-02-11T05:00:00Z,2026,2,,,2026-02-11T19:21:08Z,,0,0,09000064b919eb25 FDA-2026-N-0302-0005,FDA,FDA-2026-N-0302,Reference 3 Codex General Standard for Food Additives 2025 Food Categories,Supporting & Related Material,Background Material,2026-02-11T05:00:00Z,2026,2,,,2026-02-11T19:21:53Z,,0,0,09000064b919eb28 FDA-2026-P-1583-0003,FDA,FDA-2026-P-1583,Exhibit A - Statement of Grounds,Supporting & Related Material,Background Material,2026-02-11T05:00:00Z,2026,2,,,2026-02-11T23:00:04Z,,0,0,09000064b91a334f FDA-2026-P-1534-0003,FDA,FDA-2026-P-1534,Attachment 1 - Change.org - Results page,Supporting & Related Material,Background Material,2026-02-10T05:00:00Z,2026,2,,,2026-02-10T22:27:32Z,,0,0,09000064b919efc7 FDA-2026-P-1537-0004,FDA,FDA-2026-P-1537,Exhibit B,Supporting & Related Material,Background Material,2026-02-10T05:00:00Z,2026,2,,,2026-02-10T23:51:47Z,,0,0,09000064b919a880 FDA-2026-P-1537-0003,FDA,FDA-2026-P-1537,Exhibit A,Supporting & Related Material,Background Material,2026-02-10T05:00:00Z,2026,2,,,2026-02-10T23:51:43Z,,0,0,09000064b919a87f FDA-2026-P-1450-0004,FDA,FDA-2026-P-1450,Attachment 2 - Premarin Duavive EMA Full Prescribing Information,Supporting & Related Material,Background Material,2026-02-09T05:00:00Z,2026,2,,,2026-02-09T23:11:38Z,,0,0,09000064b919ae02 FDA-1985-P-0507-0002,FDA,FDA-1985-P-0507,"Background Material re Citizen Petition from Roxane Laboratories, Inc.",Supporting & Related Material,Background Material,2026-02-09T05:00:00Z,2026,2,,,2026-02-09T20:45:13Z,,0,0,090000648561f5bb FDA-2026-P-0748-0007,FDA,FDA-2026-P-0748,Attachment 4-RLD PI,Supporting & Related Material,Background Material,2026-02-09T05:00:00Z,2026,2,,,2026-02-09T23:30:56Z,,0,0,09000064b91970f7 FDA-2026-P-1450-0003,FDA,FDA-2026-P-1450,Attachment 1 - Duavee Full Prescribing Information for Citizen Petition 02-08-2026,Supporting & Related Material,Background Material,2026-02-09T05:00:00Z,2026,2,,,2026-02-09T23:11:36Z,,0,0,09000064b919ae01 FDA-2023-P-0172-0039,FDA,FDA-2023-P-0172,Exhibit K_Redacted,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-07T00:02:02Z,,0,0,09000064b919073e FDA-2023-P-0172-0028,FDA,FDA-2023-P-0172,Exhibit J,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-06T23:55:17Z,,0,0,09000064b91904a3 FDA-2026-P-1373-0007,FDA,FDA-2026-P-1373,Exhibit E,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-07T01:59:21Z,,0,0,09000064b9196c13 FDA-2026-P-1373-0008,FDA,FDA-2026-P-1373,Exhibit A_Redacted,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-07T01:59:26Z,,0,0,09000064b9196c19 FDA-2026-P-1373-0009,FDA,FDA-2026-P-1373,Exhibit B_Redacted,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-07T01:59:30Z,,0,0,09000064b9196c1a FDA-2026-P-1373-0003,FDA,FDA-2026-P-1373,Exhibit A,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-07T01:58:52Z,,0,0,09000064b9196c08 FDA-2024-C-3384-0005,FDA,FDA-2024-C-3384,Reference 1_Redacted,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-06T20:58:10Z,,0,0,09000064b91947ed FDA-2023-P-0172-0023,FDA,FDA-2023-P-0172,Exhibit E,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-06T23:53:08Z,,0,0,09000064b9190474 FDA-2023-P-0172-0033,FDA,FDA-2023-P-0172,Exhibit C_Redacted,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-06T23:59:17Z,,0,0,09000064b919070d FDA-2023-P-0172-0030,FDA,FDA-2023-P-0172,Exhibit L,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-06T23:57:46Z,,0,0,09000064b9196ddd FDA-2023-P-0172-0019,FDA,FDA-2023-P-0172,Exhibit A,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-06T23:51:18Z,,0,0,09000064b919042d FDA-2023-P-0172-0024,FDA,FDA-2023-P-0172,Exhibit F,Supporting & Related Material,Background Material,2026-02-06T05:00:00Z,2026,2,,,2026-02-06T23:53:53Z,,0,0,09000064b919047a