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206 rows where docket_id = "FDA-2022-N-2390" and posted_year = 2026 sorted by posted_date descending

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document_type 3

  • Supporting & Related Material 168
  • Other 37
  • Notice 1

posted_year 1

  • 2026 · 206 ✖

agency_id 1

  • FDA 206
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2022-N-2390-0789 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Notice of Participation in Vanda Hearing from McDermott, Will & Schulte Other General Correspondence 2026-08-13T04:00:00Z 2026 8 2026-08-13T04:00:00Z   2026-08-13T23:24:49Z   0 0 09000064b936368b
FDA-2022-N-2390-0791 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 CDER's Notice of Submission of 21 C.F.R. 12.85(a) and (b) Materials to Dockets Other Additional Information 2026-08-13T04:00:00Z 2026 8 2026-08-13T04:00:00Z   2026-08-13T23:25:10Z   0 0 09000064b9439d01
FDA-2022-N-2390-0790 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Notice of Entry of Appearance as a Party Representative for CDER Other Appearance Request 2026-08-13T04:00:00Z 2026 8 2026-08-13T04:00:00Z   2026-08-13T23:25:01Z   0 0 09000064b94388ff
FDA-2022-N-2390-0792 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Vanda Pharmaceuticals Inc's Notice of Submission of 21 C.F.R. 12.85(b) Materials to Dockets Management Other Additional Information 2026-08-13T04:00:00Z 2026 8 2026-08-13T04:00:00Z   2026-08-13T23:25:19Z   0 0 09000064b9439d03
FDA-2022-N-2390-0697 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 011 - 014 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T17:59:44Z   0 0 09000064b94109cb
FDA-2022-N-2390-0723 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 163 - CONFIDENTIAL Letter from Tracy Beth Hoeg MD PhD Jan_ 7 2026 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:19:59Z   0 0 09000064b9417010
FDA-2022-N-2390-0742 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 182 - CONFIDENTIAL FDACDER000001_4_Part 7 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:23:14Z   0 0 09000064b941a34a
FDA-2022-N-2390-0750 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 190 - CONFIDENTIAL FDACDER002668_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:24:45Z   0 0 09000064b941a4ea
FDA-2022-N-2390-0783 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 223 - CONFIDENTIAL REQ2022-2574_FDACDER000884_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:29:52Z   0 0 09000064b941bc19
FDA-2022-N-2390-0718 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 099 - 117 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:19:06Z   0 0 09000064b9416b90
FDA-2022-N-2390-0728 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 168 - CONFIDENTIAL FOIA Emails - Binder 5 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:20:38Z   0 0 09000064b9417018
FDA-2022-N-2390-0773 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 213 - CONFIDENTIAL FDACDER005718_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:28:45Z   0 0 09000064b941babd
FDA-2022-N-2390-0776 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 216 - CONFIDENTIAL FDACDER005718_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:29:01Z   0 0 09000064b941bb98
FDA-2022-N-2390-0744 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 184 - CONFIDENTIAL FDACDER002399-FDACDER003300_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:23:48Z   0 0 09000064b941a3da
FDA-2022-N-2390-0748 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 188 - CONFIDENTIAL FDACDER002399-FDACDER003300_Part 6 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:24:34Z   0 0 09000064b941a3e0
FDA-2022-N-2390-0756 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 196 - CONFIDENTIAL FDACDER002668_Part 8 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:25:33Z   0 0 09000064b941a4f2
FDA-2022-N-2390-0764 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 204 - CONFIDENTIAL FDACDER003901_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:26:35Z   0 0 09000064b941ba4d
FDA-2022-N-2390-0702 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 039 - 2013 Signal et al Sleep Jet lag Pilots PSG Sleep Fragmentation Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:12:47Z   0 0 09000064b94109d0
FDA-2022-N-2390-0787 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 227 - CONFIDENTIAL REQ2022-2574_FDACDER000884_Part 8 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:30:18Z   0 0 09000064b941bc52
FDA-2022-N-2390-0778 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 218 - CONFIDENTIAL FDACDER005718-FDACDER006601_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:29:12Z   0 0 09000064b941bb9a
FDA-2022-N-2390-0726 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 166 - CONFIDENTIAL FOIA Emails - Binder 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:20:28Z   0 0 09000064b9417016
FDA-2022-N-2390-0749 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 189 - CONFIDENTIAL FDACDER002668_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:24:40Z   0 0 09000064b941a3e1
FDA-2022-N-2390-0782 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 222 - CONFIDENTIAL REQ2022-2574_FDACDER000884_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:29:43Z   0 0 09000064b941bc18
FDA-2022-N-2390-0703 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 040 - 2013 Weingarten and Collop CHEST Sleep Deprive Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:16:48Z   0 0 09000064b94109d1
FDA-2022-N-2390-0751 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 191 - CONFIDENTIAL FDACDER002668_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:24:51Z   0 0 09000064b941a4eb
FDA-2022-N-2390-0761 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 201 - CONFIDENTIAL FDACDER003901_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:26:10Z   0 0 09000064b941b96e
FDA-2022-N-2390-0765 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 205 - CONFIDENTIAL FDACDER004517_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:26:44Z   0 0 09000064b941ba4e
FDA-2022-N-2390-0784 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 224 - CONFIDENTIAL REQ2022-2574_FDACDER000884_Part 5 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:30:00Z   0 0 09000064b941bc4f
FDA-2022-N-2390-0707 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 044 - 2018 Zeeuw The alerting effect of the wake maintenance zone during 40 hours of sleep deprivation Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:17:12Z   0 0 09000064b9410be4
FDA-2022-N-2390-0711 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 048 - 32 Dijk_2002_integration of sleep-wake and CR Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:16:19Z   0 0 09000064b9410be8
FDA-2022-N-2390-0752 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 192 - CONFIDENTIAL FDACDER002668_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:25:03Z   0 0 09000064b941a4ec
FDA-2022-N-2390-0772 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 212 - CONFIDENTIAL FDACDER005117_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:28:24Z   0 0 09000064b941babc
FDA-2022-N-2390-0777 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 217 - CONFIDENTIAL FDACDER005718_Part 5 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:29:07Z   0 0 09000064b941bb99
FDA-2022-N-2390-0705 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 042 - 2015 Abbott et al Psych Clin N Am - CRSDs Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:13:01Z   0 0 09000064b9410be2
FDA-2022-N-2390-0706 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 043 - 2017 Reichert Cognitive brain responses during circadian wake-promotion Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:16:59Z   0 0 09000064b9410be3
FDA-2022-N-2390-0730 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 170 - CONFIDENTIAL FOIA Emails - Binder 7 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:21:03Z   0 0 09000064b941701b
FDA-2022-N-2390-0746 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 186 - CONFIDENTIAL FDACDER002399-FDACDER003300_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:24:14Z   0 0 09000064b941a3dc
FDA-2022-N-2390-0774 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 214 - CONFIDENTIAL FDACDER005718_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:28:50Z   0 0 09000064b941babe
FDA-2022-N-2390-0747 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 187 - CONFIDENTIAL FDACDER002399-FDACDER003300_Part 5 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:24:20Z   0 0 09000064b941a3df
FDA-2022-N-2390-0757 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 197 - CONFIDENTIAL FDACDER003301-FDACDER003900_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:25:39Z   0 0 09000064b941a4f3
FDA-2022-N-2390-0731 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 171 - CONFIDENTIAL FOIA Emails - Binder 8 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:21:13Z   0 0 09000064b941701c
FDA-2022-N-2390-0767 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 207 - CONFIDENTIAL FDACDER004517_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:27:03Z   0 0 09000064b941ba50
FDA-2022-N-2390-0771 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 211 - CONFIDENTIAL FDACDER005117_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:28:18Z   0 0 09000064b941babb
FDA-2022-N-2390-0700 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 037 - 2008 Groeger et al PER3 polymorphism and performance SLEEP Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T18:35:51Z   0 0 09000064b94109ce
FDA-2022-N-2390-0733 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 173 - CONFIDENTIAL FDACDER000001_001_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:21:42Z   0 0 09000064b941701e
FDA-2022-N-2390-0704 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 041 - 2014 Basner et al SLEEP Behavior Socioeconomic Sleep duration and timing Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:12:56Z   0 0 09000064b94109d2
FDA-2022-N-2390-0786 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 226 - CONFIDENTIAL REQ2022-2574_FDACDER000884_Part 7 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:30:12Z   0 0 09000064b941bc51
FDA-2022-N-2390-0694 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Vanda’s Pharmaceuticals Inc's Section 12.85(b) Certifications Other Certifications 2026-08-10T04:00:00Z 2026 8 2026-08-10T04:00:00Z   2026-08-13T19:52:15Z   0 0 09000064b940b463
FDA-2022-N-2390-0780 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 220 - CONFIDENTIAL REQ2022-2574_FDACDER000884_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:29:23Z   0 0 09000064b941bc10
FDA-2022-N-2390-0716 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 061 - 075 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:18:55Z   0 0 09000064b94112c7
FDA-2022-N-2390-0736 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 176 - CONFIDENTIAL FDACDER000001_4_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:22:16Z   0 0 09000064b94166c9
FDA-2022-N-2390-0720 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 151 - 162 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:19:16Z   0 0 09000064b9417008
FDA-2022-N-2390-0724 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 164 - CONFIDENTIAL FOIA Emails - Binder 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:20:18Z   0 0 09000064b9417013
FDA-2022-N-2390-0729 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 169 - CONFIDENTIAL FOIA Emails - Binder 6 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:20:43Z   0 0 09000064b941701a
FDA-2022-N-2390-0768 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 208 - CONFIDENTIAL FDACDER004517_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:27:08Z   0 0 09000064b941bab8
FDA-2022-N-2390-0781 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 221 - CONFIDENTIAL REQ2022-2574_FDACDER000884_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:29:28Z   0 0 09000064b941bc17
FDA-2022-N-2390-0741 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 181 - CONFIDENTIAL FDACDER000001_4_Part 6 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:23:10Z   0 0 09000064b941a349
FDA-2022-N-2390-0762 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 202 - CONFIDENTIAL FDACDER003901_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:26:23Z   0 0 09000064b941ba4b
FDA-2022-N-2390-0775 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 215 - CONFIDENTIAL FDACDER005718_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:28:56Z   0 0 09000064b941bb97
FDA-2022-N-2390-0738 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 178 - CONFIDENTIAL FDACDER000001_4_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:22:38Z   0 0 09000064b941a2f8
FDA-2022-N-2390-0779 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 219 - CONFIDENTIAL FDACDER005718-FDACDER006601_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:29:18Z   0 0 09000064b941bb9d
FDA-2022-N-2390-0785 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 225 - CONFIDENTIAL REQ2022-2574_FDACDER000884_Part 6 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:30:06Z   0 0 09000064b941bc50
FDA-2022-N-2390-0692 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Letter from McDermott Will & Schulte to FDA DMS Other Letter(s) 2026-08-10T04:00:00Z 2026 8 2026-08-10T04:00:00Z   2026-08-13T19:50:23Z   0 0 09000064b940b3ec
FDA-2022-N-2390-0708 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 045 - 29 Travnickova-Bendova 2002 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:17:19Z   0 0 09000064b9410be5
FDA-2022-N-2390-0722 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 164-228 PUBLIC Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:19:47Z   0 0 09000064b941700d
FDA-2022-N-2390-0754 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 194 - CONFIDENTIAL FDACDER002668_Part 6 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:25:23Z   0 0 09000064b941a4f0
FDA-2022-N-2390-0727 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 167 - CONFIDENTIAL FOIA Emails - Binder 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:20:33Z   0 0 09000064b9417017
FDA-2022-N-2390-0734 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 174 - CONFIDENTIAL FDACDER000001_001_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:21:47Z   0 0 09000064b9417020
FDA-2022-N-2390-0753 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 193 - CONFIDENTIAL FDACDER002668_Part 5 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:25:09Z   0 0 09000064b941a4ef
FDA-2022-N-2390-0763 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 203 - CONFIDENTIAL FDACDER003901_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:26:29Z   0 0 09000064b941ba4c
FDA-2022-N-2390-0717 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 076 - 098 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:19:01Z   0 0 09000064b94112c8
FDA-2022-N-2390-0721 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 163 - PUBLIC Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:19:24Z   0 0 09000064b9417009
FDA-2022-N-2390-0725 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 165 - CONFIDENTIAL FOIA Emails - Binder 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:20:23Z   0 0 09000064b9417014
FDA-2022-N-2390-0743 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 183 - CONFIDENTIAL FDACDER002399-FDACDER003300_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:23:40Z   0 0 09000064b941a34b
FDA-2022-N-2390-0755 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 195 - CONFIDENTIAL FDACDER002668_Part 7 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:25:28Z   0 0 09000064b941a4f1
FDA-2022-N-2390-0693 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Vanda Pharmaceuticals Inc.’s Narrative Statement Other Statement 2026-08-10T04:00:00Z 2026 8 2026-08-10T04:00:00Z   2026-08-10T17:58:18Z   0 0 09000064b940b3ee
FDA-2022-N-2390-0699 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 036 - 2008 Edinger et al SLEEP Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:16:29Z   0 0 09000064b94109cd
FDA-2022-N-2390-0710 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 047 - 31 Lockley et al Encyclopedia Sleep - Book chapter 2013 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:17:32Z   0 0 09000064b9410be7
FDA-2022-N-2390-0737 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 177 - CONFIDENTIAL FDACDER000001_4_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:22:24Z   0 0 09000064b941a2f6
FDA-2022-N-2390-0701 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 038 - 2010 Darwent et al SLEEP Jet Lag Pilots Sleep Distribution Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T18:35:58Z   0 0 09000064b94109cf
FDA-2022-N-2390-0788 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 228 - CONFIDENTIAL REQ2022-2574_FDACDER000884_Part 9 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:30:24Z   0 0 09000064b941bc53
FDA-2022-N-2390-0698 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 015 - 035 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T18:00:04Z   0 0 09000064b94109cc
FDA-2022-N-2390-0695 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Index to Documentary Submissions Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T17:59:09Z   0 0 09000064b940f18c
FDA-2022-N-2390-0696 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 001 - 010 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T17:59:37Z   0 0 09000064b94109ca
FDA-2022-N-2390-0712 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 049 - 34 Monk_2003_The role of chronobiology Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:17:41Z   0 0 09000064b94112c3
FDA-2022-N-2390-0715 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 058 - 060 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:18:27Z   0 0 09000064b94112c6
FDA-2022-N-2390-0732 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 172 - CONFIDENTIAL FDACDER000001_001_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:21:18Z   0 0 09000064b941701d
FDA-2022-N-2390-0735 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 175 - CONFIDENTIAL FDACDER000001_001_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:21:53Z   0 0 09000064b9417021
FDA-2022-N-2390-0739 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 179 - CONFIDENTIAL FDACDER000001_4_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:22:46Z   0 0 09000064b941a344
FDA-2022-N-2390-0769 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 209 - CONFIDENTIAL FDACDER005117_Part 1 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:28:06Z   0 0 09000064b941bab9
FDA-2022-N-2390-0709 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 046 - 2_Rosenberg_2005_An assessment of the efficacy Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:17:26Z   0 0 09000064b9410be6
FDA-2022-N-2390-0713 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 050 - 36 Rajaratnam2001 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:18:16Z   0 0 09000064b94112c4
FDA-2022-N-2390-0714 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 051 - 057 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:18:21Z   0 0 09000064b94112c5
FDA-2022-N-2390-0740 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 180 - CONFIDENTIAL FDACDER000001_4_Part 5 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:23:05Z   0 0 09000064b941a346
FDA-2022-N-2390-0760 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 200 - CONFIDENTIAL FDACDER003301-FDACDER003900_Part 4 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:26:01Z   0 0 09000064b941b96d
FDA-2022-N-2390-0745 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 185 - CONFIDENTIAL FDACDER002399-FDACDER003300_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:24:08Z   0 0 09000064b941a3db
FDA-2022-N-2390-0758 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 198 - CONFIDENTIAL FDACDER003301-FDACDER003900_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:25:52Z   0 0 09000064b941b967
FDA-2022-N-2390-0719 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 118 - 150 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:19:12Z   0 0 09000064b9417006
FDA-2022-N-2390-0759 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 199 - CONFIDENTIAL FDACDER003301-FDACDER003900_Part 3 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:25:56Z   0 0 09000064b941b96c
FDA-2022-N-2390-0766 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 206 - CONFIDENTIAL FDACDER004517_Part 2 Supporting & Related Material Background Material 2026-08-10T04:00:00Z 2026 8     2026-08-10T19:26:58Z   0 0 09000064b941ba4f

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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;
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