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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 ANDA SUIT RE: DIAZEPAM INTENSOL 5MG PER ML-CLOSED 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;