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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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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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id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
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posted_year INTEGER,
posted_month INTEGER,
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last_modified TEXT,
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CREATE INDEX idx_docs_year ON documents(posted_year);
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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;