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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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656 rows where docket_id = "FDA-2022-N-2390" sorted by posted_date descending

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  • Supporting & Related Material 604
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  • FDA 656
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2390-0669 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.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) Notice Hearings 2026-06-03T04:00:00Z 2026 6 2026-06-03T04:00:00Z 2026-07-07T03:59:59Z 2026-06-03T17:59:58Z 2026-11046 1 0 09000064b930c153
FDA-2022-N-2390-0671 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Attachment to Reference 1 CRD PROCEDURES (eff. March 28 2016) Supporting & Related Material Background Material 2026-06-03T04:00:00Z 2026 6     2026-06-03T19:30:31Z   0 0 09000064b930be45
FDA-2022-N-2390-0670 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Reference 1 Case Development Order Supporting & Related Material Background Material 2026-06-03T04:00:00Z 2026 6     2026-06-03T19:28:54Z   0 0 09000064b930be44
FDA-2022-N-2390-0647 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 49 - 2020_10_28 NDA 205677 S-005 Driving Study ON FDRR Response Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:40:27Z   0 0 09000064b92e1250
FDA-2022-N-2390-0654 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 56 - 2020_09_02 NDA 205677 S-004 Vanda FDRR - OND Level Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:10Z   0 0 09000064b92e125f
FDA-2022-N-2390-0661 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 63 - vp-vec-162-2102-body Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:55Z   0 0 09000064b92e1268
FDA-2022-N-2390-0663 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 65 - vp-vec-162-3107-body Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:42:04Z   0 0 09000064b92e126a
FDA-2022-N-2390-0664 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 66 - vp-vec-162-0101-e3-16-1-01-protocol Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:42:11Z   0 0 09000064b92e1277
FDA-2022-N-2390-0667 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 69 - vp-vec-162-2102-e3-16-1-01-protocol Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:42:39Z   0 0 09000064b92e127e
FDA-2022-N-2390-0668 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 70 - Protocol 3107 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:42:43Z   0 0 09000064b92e127f
FDA-2022-N-2390-0636 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 38 - 2019_07_19 NDA 205677 S-004 FDA Deficiencies Preclude Discussions Letter Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:14Z   0 0 09000064b92dcf33
FDA-2022-N-2390-0604 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 06 - sNDA205677-S004_JetLag_Complete-Response-Letter Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:35:21Z   0 0 09000064b92e07b1
FDA-2022-N-2390-0611 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 13 - Vanda response to IR Jan 28, 2019 clin-info-amend-resp-fda-info-req-20190116 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:36:05Z   0 0 09000064b92e07c2
FDA-2022-N-2390-0612 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 14 - 2006_02_01 IND 54776 Special Protocol - No Agreement Letter Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:36:11Z   0 0 09000064b92e07c3
FDA-2022-N-2390-0614 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 16 - 2006_02_23 IND 054776 FDA Response to Meeting Request Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:36:34Z   0 0 09000064b92e07c7
FDA-2022-N-2390-0618 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 20 - 2009_10_02 IND 54776 Special Protocol - No Agreement Letter Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:36:55Z   0 0 09000064b92e07d5
FDA-2022-N-2390-0630 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 32 - summary-clin-efficacy-jet-lag-disorder Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:47Z   0 0 09000064b92e07e5
FDA-2022-N-2390-0595 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Certificate of Service Other Certificate of Service 2026-05-20T04:00:00Z 2026 5 2026-05-20T04:00:00Z   2026-05-20T15:33:34Z   0 0 09000064b92e0701
FDA-2022-N-2390-0646 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 48 - 2020_10_05 NDA 205677 S-004 Vanda Response to Request for Additional Information Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:40:19Z   0 0 09000064b92e124f
FDA-2022-N-2390-0653 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 55 - 2020_08_04 NDA 205677 S-004 FDA Denial of FDRR from Dr Dunn (ON) Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:05Z   0 0 09000064b92e125e
FDA-2022-N-2390-0665 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 67 - vp-vec-162-1201-e3-16-1-01-protocol Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:42:28Z   0 0 09000064b92e1278
FDA-2022-N-2390-0634 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 36 - 2019_01_28 NDA 205677 S-004 Response to IR - Info on PROs Used Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:05Z   0 0 09000064b92dcf31
FDA-2022-N-2390-0635 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 37 - 2019_07_19 NDA 205677 Email Noting Additional Supplement Numbers Assigned Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:10Z   0 0 09000064b92dcf32
FDA-2022-N-2390-0637 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 39 - 2019_09_19 NDA 205677 S-005 FDA CRL for Driving Study Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:19Z   0 0 09000064b92dcf34
FDA-2022-N-2390-0613 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 15 - 2006_02_13 IND 054776 Meeting Request Package Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:36:16Z   0 0 09000064b92e07c6
FDA-2022-N-2390-0621 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 23 - ICSD-3 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:37:23Z   0 0 09000064b92e07d8
FDA-2022-N-2390-0623 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 25 - cover 0086 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:02Z   0 0 09000064b92e07da
FDA-2022-N-2390-0627 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 29 - synopses-indiv-studies Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:32Z   0 0 09000064b92e07e1
FDA-2022-N-2390-0631 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 33 - proposed draft labeling clean Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:52Z   0 0 09000064b92e07e6
FDA-2022-N-2390-0645 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 47 - 2020_09_23 NDA 205677 S-004 Vanda Response to Request for Additional Information Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:40:14Z   0 0 09000064b92e124e
FDA-2022-N-2390-0649 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 51 - 2018_02_28 Study 3107 Statistical Analysis Plan NDA 205677 Oct 16, 2018 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:40:48Z   0 0 09000064b92e125a
FDA-2022-N-2390-0651 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 53 - 2019_08_16 NDA 205677 S-004 FDA Unireview for JLD Indication Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:40:57Z   0 0 09000064b92e125c
FDA-2022-N-2390-0658 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 60 - SAP 3101 vp-vec-162-3101-e3-16-1-09 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:42Z   0 0 09000064b92e1263
FDA-2022-N-2390-0659 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 61 - vp-vec-162-1201-body Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:46Z   0 0 09000064b92e1266
FDA-2022-N-2390-0662 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 64 - vp-vec-162-3101-body Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:42:00Z   0 0 09000064b92e1269
FDA-2022-N-2390-0599 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 01- Billy Dunn Vanda aNDA 205677 S005 Dispute Appeal Denied Letter Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:34:45Z   0 0 09000064b92e0788
FDA-2022-N-2390-0600 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 02 - NDA205677S4_TypeA-Meeting-Minutes Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:34:50Z   0 0 09000064b92e07a1
FDA-2022-N-2390-0601 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 03 - Billy Dunn Vanda SDNA 205677 S004 Dispute Appeal Denied Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:34:55Z   0 0 09000064b92e07a2
FDA-2022-N-2390-0605 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 07 - NDA205677-S004_Unireview Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:35:26Z   0 0 09000064b92e07b3
FDA-2022-N-2390-0609 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 11 - NDA 205677 Response to IR September 23, 2020 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:35:55Z   0 0 09000064b92e07bf
FDA-2022-N-2390-0616 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 18 - 2009_07_20 IND 54776 Meeting Minutes for June 26, 2009 Meeting Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:36:45Z   0 0 09000064b92e07c9
FDA-2022-N-2390-0617 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 19 - 2009_09_04 IND 54776 Revised Meeting Minutes for June 26, 2009 Meeting Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:36:51Z   0 0 09000064b92e07ca
FDA-2022-N-2390-0624 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 26 - S004 Cover Letter Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:07Z   0 0 09000064b92e07de
FDA-2022-N-2390-0629 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 31 - clinical-overview Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:42Z   0 0 09000064b92e07e4
FDA-2022-N-2390-0642 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 44 - 2020_02_11 NDA 205677 S-004 FDA FDRR Meeting Minutes (finalized 10-28-20) Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:59Z   0 0 09000064b92e1247
FDA-2022-N-2390-0643 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 45 - 2020_09_15 NDA 205677 S-004 FDA Acknowledges FDRR to Dr Stein delegated to Dr Thanh Hai (OND) Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:40:05Z   0 0 09000064b92e124a
FDA-2022-N-2390-0650 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 52 - 2019_07_23 NDA 205677 S-004 Clinical Outcome Assessment Consult Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:40:52Z   0 0 09000064b92e125b
FDA-2022-N-2390-0655 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 57 - 2020_10_21 NDA 205677 S-004 FDA Denial of FDRR from Dr Thanh Hai (OND) Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:15Z   0 0 09000064b92e1260
FDA-2022-N-2390-0656 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 58 - Final SAP vp-vec-162-3107-e3-16-1-09 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:20Z   0 0 09000064b92e1261
FDA-2022-N-2390-0660 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 62 - vp-vec-162-0101-summary-report Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:50Z   0 0 09000064b92e1267
FDA-2022-N-2390-0633 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 35 - 2018_12_06 NDA 205677 S-004 Response to IR - Regulatory History of Studies 3101 and 3107 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:01Z   0 0 09000064b92dcf30
FDA-2022-N-2390-0639 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 41 - 2020_01_03 NDA 205677 S-004 Vanda FDRR - ON Level Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:44Z   0 0 09000064b92dcf36
FDA-2022-N-2390-0597 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Index of Documents Vanda JLD Hearing - 05/15/2026 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:34:13Z   0 0 09000064b92e0705
FDA-2022-N-2390-0598 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Indices to Vanda Exhibits in Appendix I and II Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:34:21Z   0 0 09000064b92e0706
FDA-2022-N-2390-0603 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 05 - Mary Thanh Hai Dispute Denial Letter_sNDA 205677-004 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:35:04Z   0 0 09000064b92e07ac
FDA-2022-N-2390-0625 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 27 - summary-clin-safety Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:12Z   0 0 09000064b92e07df
FDA-2022-N-2390-0596 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 CDER's 12.85 Narrative Position Statement - Tasimelteon Jet Lag Matter Other Disclosure of Date and Information 2026-05-20T04:00:00Z 2026 5 2026-05-20T04:00:00Z   2026-05-20T15:33:36Z   0 0 09000064b92e0703
FDA-2022-N-2390-0594 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Cover Letter - 12.85 Submission Other Letter(s) 2026-05-20T04:00:00Z 2026 5 2026-05-20T04:00:00Z   2026-05-20T15:33:32Z   0 0 09000064b92e06ff
FDA-2022-N-2390-0652 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 54 - 2019_09_30 NDA 205677 S-004 FDA Type A Meeting Minutes Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:01Z   0 0 09000064b92e125d
FDA-2022-N-2390-0657 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 59 - SAP 2102 vp-vec-162-2102-e3-16-1-09 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:41:25Z   0 0 09000064b92e1262
FDA-2022-N-2390-0666 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 68 - vp-vec-162-3101-e3-16-1-01 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:42:32Z   0 0 09000064b92e127d
FDA-2022-N-2390-0640 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 42 - 2020_01_16 NDA 205677 S-004 FDA Acknowledges FDRR forwarded to Dr Dunn (ON) Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:49Z   0 0 09000064b92dcf37
FDA-2022-N-2390-0602 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 04 - Final Agency Decision Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:34:59Z   0 0 09000064b92e07a4
FDA-2022-N-2390-0607 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 09 - IND 128352 new protocol Aug 16, 2016 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:35:46Z   0 0 09000064b92e07ba
FDA-2022-N-2390-0610 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 12 - Vanda Pharmaceuticals FDA Update for HETLIOZ in the Treatment of Jet Lag Disorder Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:36:00Z   0 0 09000064b92e07c1
FDA-2022-N-2390-0615 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 17 - 2007_05_30 IND 54776 Meeting Minutes for Apr 30, 2007 Meeting Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:36:38Z   0 0 09000064b92e07c8
FDA-2022-N-2390-0619 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 21 - 2015_07_13 IND 054776 Meeting Minutes for June 15, 2015 Meeting Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:37:13Z   0 0 09000064b92e07d6
FDA-2022-N-2390-0626 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 28 - synopses-indiv-studies 1 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:28Z   0 0 09000064b92e07e0
FDA-2022-N-2390-0628 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 30 - tabular-listing Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:37Z   0 0 09000064b92e07e3
FDA-2022-N-2390-0644 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 46 - 2020_09_15 NDA 205677 S-004 FDA Interim Response to FDRR - FDA Requests Additional Information Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:40:09Z   0 0 09000064b92e124b
FDA-2022-N-2390-0648 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 50 - 2019_08_16 NDA 205677 S-004 FDA CRL for JLD Indication Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:40:41Z   0 0 09000064b92e1259
FDA-2022-N-2390-0638 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 40 - 2019_09_27 NDA 205677 S-004 Type A Meeting Preliminary Comments Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:23Z   0 0 09000064b92dcf35
FDA-2022-N-2390-0641 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 43 - 2020_01_31 NDA 205677 S-004 FDA Interim Response to FDRR - FDA Requests Meeting Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:39:54Z   0 0 09000064b92dcf38
FDA-2022-N-2390-0606 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 08 - IND 128352 new protocol 3107 Sep 15, 2017 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:35:32Z   0 0 09000064b92e07b8
FDA-2022-N-2390-0608 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 10 - NCT03291041 A Proof of Concept Study to Evaluate the Effects of Tasimelteon and Placebo in Travelers With Jet Lag Disorder Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:35:51Z   0 0 09000064b92e07be
FDA-2022-N-2390-0620 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 22 - BEST Bookshelf_NBK326791 Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:37:18Z   0 0 09000064b92e07d7
FDA-2022-N-2390-0622 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 24 - annotated draft labeling Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:37:29Z   0 0 09000064b92e07d9
FDA-2022-N-2390-0632 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 34 - 2013_12_18 NDA 205677 Clinical Review Supporting & Related Material Background Material 2026-05-20T04:00:00Z 2026 5     2026-05-20T15:38:56Z   0 0 09000064b92e07e7
FDA-2022-N-2390-0591 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Letter from FDA OC to McDermott Will & Emery Other Letter(s) 2026-04-14T04:00:00Z 2026 4 2026-04-14T04:00:00Z   2026-04-14T23:02:45Z   0 0 09000064b927ab19
FDA-2022-N-2390-0592 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Vanda letter re CDER submissions Other Letter(s) 2026-04-14T04:00:00Z 2026 4 2026-04-14T04:00:00Z   2026-04-14T23:11:31Z   0 0 09000064b927c731
FDA-2022-N-2390-0590 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 (on behalf of Vanda Pharmaceuticals Inc.) to FDA OC Other Letter(s) 2026-04-08T04:00:00Z 2026 4 2026-04-08T04:00:00Z   2026-04-08T16:11:32Z   0 0 09000064b925c72d
FDA-2022-N-2390-0589 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 (on behalf of Vanda Pharmaceuticals Inc.) to FDA OC Other Letter(s) 2026-03-17T04:00:00Z 2026 3 2026-03-17T04:00:00Z   2026-03-17T20:33:09Z   0 0 09000064b921d823
FDA-2022-N-2390-0588 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Letter from FDA OC to McDermott Will & Emery (on behalf of Vanda Pharmaceuticals Inc.) and FDA OCC Other Letter(s) 2026-03-03T05:00:00Z 2026 3 2026-03-03T05:00:00Z   2026-03-04T01:46:34Z   0 0 09000064b91ed918
FDA-2022-N-2390-0587 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Vanda Hearing Request for sNDA 205677-004 (tasimelteon) Other Request for Hearing 2026-02-26T05:00:00Z 2026 2 2026-02-26T05:00:00Z   2026-02-27T00:15:15Z   0 0 09000064b91df99f
FDA-2022-N-2390-0586 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Vanda Hearing Request for sNDA 205677-004 (tasimelteon) Other Request for Hearing 2026-02-09T05:00:00Z 2026 2 2026-02-09T05:00:00Z   2026-02-09T23:37:26Z   0 0 09000064b919a1ca
FDA-2022-N-2390-0585 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Revised Letter re: CDER and Vanda’s Joint Request Other Letter(s) 2025-10-21T04:00:00Z 2025 10 2025-10-21T04:00:00Z   2025-10-21T17:13:39Z   0 0 09000064b903ed93
FDA-2022-N-2390-0584 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Letter from FDA OC to Vanda Pharmaceuticals Inc. and FDA CDER Other Letter(s) 2025-10-15T04:00:00Z 2025 10 2025-10-15T04:00:00Z   2025-10-15T15:52:08Z   0 0 09000064b9015606
FDA-2022-N-2390-0581 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 Submission in Support of Summary Judgment to the Applicant or a Hearing on Approvability Other Brief 2025-03-07T05:00:00Z 2025 3 2025-03-07T05:00:00Z   2025-10-15T15:05:12Z   0 0 09000064869b6834
FDA-2022-N-2390-0161 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) Notice Notice of Denial 2025-03-07T05:00:00Z 2025 3 2025-03-07T05:00:00Z   2025-03-07T14:52:35Z 2025-03697 0 0 09000064869b9231
FDA-2022-N-2390-0580 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Cover Letter from Vanda Pharmaceuticals Inc. Other Letter(s) 2025-03-07T05:00:00Z 2025 3 2025-03-07T05:00:00Z   2025-10-15T15:04:57Z   0 0 09000064869b682f
FDA-2022-N-2390-0582 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Declaration of Thomas Roth Other Declaration(s) 2025-03-07T05:00:00Z 2025 3 2025-03-07T05:00:00Z   2025-10-15T15:05:31Z   0 0 09000064869b6836
FDA-2022-N-2390-0583 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Declaration of Daniel Combs Other Declaration(s) 2025-03-07T05:00:00Z 2025 3 2025-03-07T05:00:00Z   2025-10-15T15:05:43Z   0 0 09000064869b6838
FDA-2022-N-2390-0132 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 Submission in Support of Summary Judgment to the Applicant or a Hearing on Approvability of Tasimelteon to Treat Insomnia Associated with Difficulties with Sleep Initiation Other Brief 2025-03-04T05:00:00Z 2025 3 2025-03-04T05:00:00Z   2025-03-04T14:31:50Z   0 0 0900006486972393
FDA-2022-N-2390-0133 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 First Declaration of Thomas Roth Other Declaration(s) 2025-03-04T05:00:00Z 2025 3 2025-03-04T05:00:00Z   2025-03-04T14:31:56Z   0 0 09000064869723be
FDA-2022-N-2390-0135 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Agency Decision Hetlioz for Insomnia Other Agency Response 2025-03-04T05:00:00Z 2025 3 2025-03-04T05:00:00Z   2025-03-04T14:32:32Z   0 0 0900006486995bdc
FDA-2022-N-2390-0134 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Second Declaration of Thomas Roth Other Declaration(s) 2025-03-04T05:00:00Z 2025 3 2025-03-04T05:00:00Z   2025-03-04T14:32:01Z   0 0 09000064869723c0
FDA-2022-N-2390-0131 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Cover Letter from Vanda Pharmaceuticals Inc. Other Letter(s) 2025-03-04T05:00:00Z 2025 3 2025-03-04T05:00:00Z   2025-03-04T14:31:42Z   0 0 090000648697238f
FDA-2022-N-2390-0130 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 CDER Proposed Order_ Docket No. FDA-2022-N-2390 (Vanda Pharmaceuticals Inc. Hearing Request for sNDA 205677-012) Other Electronic Letter 2025-01-29T05:00:00Z 2025 1 2025-01-29T05:00:00Z   2025-01-29T21:43:58Z   0 0 0900006486908a5f
FDA-2022-N-2390-0071 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Response Cover Letter from Vanda Pharmaceuticals Inc. to FDA DMB Other Letter(s) 2025-01-07T05:00:00Z 2025 1 2025-01-07T05:00:00Z   2025-01-07T15:56:31Z   0 0 09000064868a3b18
FDA-2022-N-2390-0073 FDA Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing FDA-2022-N-2390 Third Declaration of Thomas Roth Other Declaration(s) 2025-01-07T05:00:00Z 2025 1 2025-01-07T05:00:00Z   2025-01-07T15:56:43Z   0 0 09000064868a45ad

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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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