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withdrawn,object_id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-2390-0585,FDA,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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
FDA-2022-N-2390-0072,FDA,FDA-2022-N-2390,Insomnia Response Submission Brief,Other,Brief,2025-01-07T05:00:00Z,2025,1,2025-01-07T05:00:00Z,,2025-01-07T15:56:37Z,,0,0,09000064868a4591