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withdrawn,object_id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-2390-0030,FDA,FDA-2022-N-2390,Response from Vanda Pharmaceuticals Inc. Response to FDA CDER,Other,Response(s),2023-10-19T04:00:00Z,2023,10,2023-10-19T04:00:00Z,,2023-10-19T19:33:28Z,,0,0,090000648610f7c8
FDA-2022-N-2390-0029,FDA,FDA-2022-N-2390,Letter from McDermott Will & Emery on behalf of Vanda Pharmaceuticals Inc.,Other,Letter(s),2023-09-29T04:00:00Z,2023,9,2023-09-29T04:00:00Z,,2023-09-29T17:42:03Z,,0,0,090000648600f7cf
FDA-2022-N-2390-0028,FDA,FDA-2022-N-2390,"Letter from McDermott Will & Emery on behalf of Vanda Pharmaceuticals, Inc to FDA CDER",Other,Letter(s),2023-09-19T04:00:00Z,2023,9,2023-09-19T04:00:00Z,,2023-09-19T18:30:32Z,,0,0,0900006485fd20d7
FDA-2022-N-2390-0026,FDA,FDA-2022-N-2390,Participation of Chief Counsel Mark Raza in re: Proposal to Refuse to Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing,Other,Memo,2023-08-30T04:00:00Z,2023,8,2023-08-30T04:00:00Z,,2023-08-30T19:13:12Z,,0,0,0900006485f14bbc
FDA-2022-N-2390-0027,FDA,FDA-2022-N-2390,Mark Raza’s Participation in Vanda Pharmaceuticals,Other,Memo,2023-08-30T04:00:00Z,2023,8,2023-08-30T04:00:00Z,,2023-08-30T19:13:23Z,,0,0,0900006485f14bc0
FDA-2022-N-2390-0025,FDA,FDA-2022-N-2390,Vanda's Response to CDER's Proposed Order,Other,Response(s),2023-08-17T04:00:00Z,2023,8,2023-08-17T04:00:00Z,,2023-08-17T18:27:06Z,,0,0,0900006485e77eab
FDA-2022-N-2390-0024,FDA,FDA-2022-N-2390,Vanda's Response to CDER's Proposed Order,Other,Response(s),2023-08-17T04:00:00Z,2023,8,2023-08-17T04:00:00Z,,2023-08-17T18:24:44Z,,0,0,0900006485e60684
FDA-2022-N-2390-0020,FDA,FDA-2022-N-2390,Cover Memorandum to Vanda RE: Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing,Supporting & Related Material,Background Material,2023-06-22T04:00:00Z,2023,6,,,2023-06-22T14:42:06Z,,0,0,0900006485bb01e9
FDA-2022-N-2390-0022,FDA,FDA-2022-N-2390,Proposed Order RE: Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing,Supporting & Related Material,Background Material,2023-06-22T04:00:00Z,2023,6,,,2023-06-22T14:42:13Z,,0,0,0900006485bb0f98
FDA-2022-N-2390-0023,FDA,FDA-2022-N-2390,ICSD-3 3rd edition (2014) Insomnia RE: Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing,Supporting & Related Material,Background Material,2023-06-22T04:00:00Z,2023,6,,,2023-06-22T17:08:07Z,,0,0,0900006485bb0f99
FDA-2022-N-2390-0021,FDA,FDA-2022-N-2390,Cover Memorandum to Commissioner RE: Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing,Supporting & Related Material,Background Material,2023-06-22T04:00:00Z,2023,6,,,2023-06-22T14:42:10Z,,0,0,0900006485bb01ea
FDA-2022-N-2390-0019,FDA,FDA-2022-N-2390,Vanda Scheduling Order,Other,Order,2023-05-25T04:00:00Z,2023,5,2023-05-25T04:00:00Z,,2023-05-25T17:26:03Z,,0,0,0900006485a613f6
FDA-2022-N-2390-0018,FDA,FDA-2022-N-2390,"Letter from McDermott Will & Emery on behalf of Vanda Pharmaceuticals, Inc to FDA CDER",Other,Letter(s),2023-04-12T04:00:00Z,2023,4,2023-04-12T04:00:00Z,,2023-04-12T17:21:59Z,,0,0,090000648593604b
FDA-2022-N-2390-0017,FDA,FDA-2022-N-2390,Letter to Matthew Warren from FDA CDER,Other,Letter(s),2023-02-21T05:00:00Z,2023,2,2023-02-21T05:00:00Z,,2023-02-21T18:53:15Z,,0,0,09000064856def37
FDA-2022-N-2390-0016,FDA,FDA-2022-N-2390,Vanda Submission Ex 032 (audio file),Other,Record of Meeting/Phone Conversation,2023-01-20T05:00:00Z,2023,1,2023-01-20T05:00:00Z,,2023-01-20T19:12:20Z,,0,0,09000064855fce7d
FDA-2022-N-2390-0014,FDA,FDA-2022-N-2390,"Letter from Vanda Pharmaceuticals, Inc to FDA CDER and FDA DMS",Other,Letter(s),2023-01-10T05:00:00Z,2023,1,2023-01-10T05:00:00Z,,2023-01-10T18:35:16Z,,0,0,09000064855d315f
FDA-2022-N-2390-0015,FDA,FDA-2022-N-2390,"Letter to Vanda Pharmaceuticals, Inc and FDA CDER",Other,Letter(s),2023-01-10T05:00:00Z,2023,1,2023-01-10T05:00:00Z,,2023-01-10T18:35:27Z,,0,0,09000064855d315d