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withdrawn,object_id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-2390-0587,FDA,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,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,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
FDA-2022-N-2390-0097,FDA,FDA-2022-N-2390,Exhibit 208,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:29:54Z,,0,0,09000064868a2ef0
FDA-2022-N-2390-0128,FDA,FDA-2022-N-2390,Exhibit 239,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:26:26Z,,0,0,09000064868a2f37
FDA-2022-N-2390-0123,FDA,FDA-2022-N-2390,Exhibit 234,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:26:56Z,,0,0,09000064868a2f32
FDA-2022-N-2390-0126,FDA,FDA-2022-N-2390,Exhibit 237,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:26:37Z,,0,0,09000064868a2f35
FDA-2022-N-2390-0090,FDA,FDA-2022-N-2390,Exhibit 201,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:29:04Z,,0,0,09000064868a2ee9
FDA-2022-N-2390-0096,FDA,FDA-2022-N-2390,Exhibit 207,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:29:48Z,,0,0,09000064868a2eef
FDA-2022-N-2390-0127,FDA,FDA-2022-N-2390,Exhibit 238,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:26:31Z,,0,0,09000064868a2f36
FDA-2022-N-2390-0088,FDA,FDA-2022-N-2390,Exhibit 199,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:28:52Z,,0,0,09000064868a3103
FDA-2022-N-2390-0103,FDA,FDA-2022-N-2390,Exhibit 214,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:32:27Z,,0,0,09000064868a2f07
FDA-2022-N-2390-0115,FDA,FDA-2022-N-2390,Exhibit 226,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:14Z,,0,0,09000064868a2f1d
FDA-2022-N-2390-0101,FDA,FDA-2022-N-2390,Exhibit 212,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:32:37Z,,0,0,09000064868a2f05
FDA-2022-N-2390-0107,FDA,FDA-2022-N-2390,Exhibit 218,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:32:05Z,,0,0,09000064868a2f0b
FDA-2022-N-2390-0120,FDA,FDA-2022-N-2390,Exhibit 231,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:30:47Z,,0,0,09000064868a2f2f
FDA-2022-N-2390-0105,FDA,FDA-2022-N-2390,Exhibit 216,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:32:18Z,,0,0,09000064868a2f09
FDA-2022-N-2390-0106,FDA,FDA-2022-N-2390,Exhibit 217,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:32:11Z,,0,0,09000064868a2f0a
FDA-2022-N-2390-0111,FDA,FDA-2022-N-2390,Exhibit 222,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:39Z,,0,0,09000064868a2f19
FDA-2022-N-2390-0113,FDA,FDA-2022-N-2390,Exhibit 224,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:26Z,,0,0,09000064868a2f1b
FDA-2022-N-2390-0079,FDA,FDA-2022-N-2390,Exhibit 190,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:27:08Z,,0,0,09000064868a27cf
FDA-2022-N-2390-0084,FDA,FDA-2022-N-2390,Exhibit 195,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:28:11Z,,0,0,09000064868a28ff
FDA-2022-N-2390-0098,FDA,FDA-2022-N-2390,Exhibit 209,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:29:59Z,,0,0,09000064868a2ef1
FDA-2022-N-2390-0074,FDA,FDA-2022-N-2390,Index to Exhibits,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:25:42Z,,0,0,09000064868a4593
FDA-2022-N-2390-0080,FDA,FDA-2022-N-2390,Exhibit 191,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:27:13Z,,0,0,09000064868a28fb
FDA-2022-N-2390-0085,FDA,FDA-2022-N-2390,Exhibit 196,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:28:17Z,,0,0,09000064868a3100
FDA-2022-N-2390-0100,FDA,FDA-2022-N-2390,Exhibit 211,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:30:11Z,,0,0,09000064868a2f04
FDA-2022-N-2390-0102,FDA,FDA-2022-N-2390,Exhibit 213,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:32:32Z,,0,0,09000064868a2f06
FDA-2022-N-2390-0104,FDA,FDA-2022-N-2390,Exhibit 215,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:32:23Z,,0,0,09000064868a2f08
FDA-2022-N-2390-0112,FDA,FDA-2022-N-2390,Exhibit 223,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:32Z,,0,0,09000064868a2f1a
FDA-2022-N-2390-0114,FDA,FDA-2022-N-2390,Exhibit 225,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:20Z,,0,0,09000064868a2f1c
FDA-2022-N-2390-0117,FDA,FDA-2022-N-2390,Exhibit 228,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:03Z,,0,0,09000064868a2f1f
FDA-2022-N-2390-0083,FDA,FDA-2022-N-2390,Exhibit 194,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:27:40Z,,0,0,09000064868a28fe
FDA-2022-N-2390-0094,FDA,FDA-2022-N-2390,Exhibit 205,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:29:37Z,,0,0,09000064868a2eed
FDA-2022-N-2390-0089,FDA,FDA-2022-N-2390,Exhibit 200,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:28:58Z,,0,0,09000064868a3104
FDA-2022-N-2390-0075,FDA,FDA-2022-N-2390,Exhibit 186,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:25:49Z,,0,0,09000064868a27cb
FDA-2022-N-2390-0076,FDA,FDA-2022-N-2390,Exhibit 187,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:25:55Z,,0,0,09000064868a27cc
FDA-2022-N-2390-0099,FDA,FDA-2022-N-2390,Exhibit 210,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:30:05Z,,0,0,09000064868a2ef2
FDA-2022-N-2390-0124,FDA,FDA-2022-N-2390,Exhibit 235,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:26:49Z,,0,0,09000064868a2f33
FDA-2022-N-2390-0122,FDA,FDA-2022-N-2390,Exhibit 233,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:30:36Z,,0,0,09000064868a2f31
FDA-2022-N-2390-0109,FDA,FDA-2022-N-2390,Exhibit 220,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:53Z,,0,0,09000064868a2f0d
FDA-2022-N-2390-0086,FDA,FDA-2022-N-2390,Exhibit 197,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:28:27Z,,0,0,09000064868a3101
FDA-2022-N-2390-0092,FDA,FDA-2022-N-2390,Exhibit 203,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:29:18Z,,0,0,09000064868a2eeb
FDA-2022-N-2390-0095,FDA,FDA-2022-N-2390,Exhibit 206,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:29:43Z,,0,0,09000064868a2eee
FDA-2022-N-2390-0129,FDA,FDA-2022-N-2390,Exhibit 240,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:26:19Z,,0,0,09000064868a2f38
FDA-2022-N-2390-0093,FDA,FDA-2022-N-2390,Exhibit 204,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:29:32Z,,0,0,09000064868a2eec
FDA-2022-N-2390-0116,FDA,FDA-2022-N-2390,Exhibit 227,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:09Z,,0,0,09000064868a2f1e
FDA-2022-N-2390-0118,FDA,FDA-2022-N-2390,Exhibit 229,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:30:57Z,,0,0,09000064868a2f20
FDA-2022-N-2390-0110,FDA,FDA-2022-N-2390,Exhibit 221,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:47Z,,0,0,09000064868a2f18
FDA-2022-N-2390-0121,FDA,FDA-2022-N-2390,Exhibit 232,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:30:41Z,,0,0,09000064868a2f30
FDA-2022-N-2390-0078,FDA,FDA-2022-N-2390,Exhibit 189,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:26:07Z,,0,0,09000064868a27ce
FDA-2022-N-2390-0091,FDA,FDA-2022-N-2390,Exhibit 202,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:29:10Z,,0,0,09000064868a2eea
FDA-2022-N-2390-0125,FDA,FDA-2022-N-2390,Exhibit 236,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:26:43Z,,0,0,09000064868a2f34
FDA-2022-N-2390-0077,FDA,FDA-2022-N-2390,Exhibit 188,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:26:01Z,,0,0,09000064868a27cd
FDA-2022-N-2390-0081,FDA,FDA-2022-N-2390,Exhibit 192,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:27:20Z,,0,0,09000064868a28fc
FDA-2022-N-2390-0087,FDA,FDA-2022-N-2390,Exhibit 198,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:28:46Z,,0,0,09000064868a3102
FDA-2022-N-2390-0082,FDA,FDA-2022-N-2390,Exhibit 193,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:27:25Z,,0,0,09000064868a28fd
FDA-2022-N-2390-0119,FDA,FDA-2022-N-2390,Exhibit 230,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:30:51Z,,0,0,09000064868a2f21
FDA-2022-N-2390-0108,FDA,FDA-2022-N-2390,Exhibit 219,Supporting & Related Material,Background Material,2024-12-31T05:00:00Z,2024,12,,,2025-04-04T15:31:58Z,,0,0,09000064868a2f0c
FDA-2022-N-2390-0046,FDA,FDA-2022-N-2390,Cover Memorandum to Vanda,Other,Memorandum,2024-11-07T05:00:00Z,2024,11,2024-11-07T05:00:00Z,,2024-11-07T18:09:38Z,,0,0,09000064867f5621
FDA-2022-N-2390-0056,FDA,FDA-2022-N-2390,Letter from FDA CDER to Kay,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:03Z,,0,0,09000064867f5632
FDA-2022-N-2390-0064,FDA,FDA-2022-N-2390,Letter from FDA CDER to Phillips,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:43Z,,0,0,09000064867f5652
FDA-2022-N-2390-0070,FDA,FDA-2022-N-2390,Letter from FDA CDER to Vanable,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:21:11Z,,0,0,09000064867f5683
FDA-2022-N-2390-0047,FDA,FDA-2022-N-2390,Letter from FDA CDER to Ancoli Israel,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:19:15Z,,0,0,09000064867f5606
FDA-2022-N-2390-0067,FDA,FDA-2022-N-2390,Letter from FDA CDER to Roth,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:57Z,,0,0,09000064867f566c
FDA-2022-N-2390-0059,FDA,FDA-2022-N-2390,Letter from FDA CDER to Morin,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:20Z,,0,0,09000064867f563a
FDA-2022-N-2390-0069,FDA,FDA-2022-N-2390,Letter from FDA CDER to Fasiello,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:21:06Z,,0,0,09000064867f567d
FDA-2022-N-2390-0048,FDA,FDA-2022-N-2390,Letter from FDA CDER to Barnett,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:19:21Z,,0,0,09000064867f5609
FDA-2022-N-2390-0068,FDA,FDA-2022-N-2390,Letter from FDA CDER to Utsumi,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:21:02Z,,0,0,09000064867f566e
FDA-2022-N-2390-0061,FDA,FDA-2022-N-2390,Letter from FDA CDER to Morphy,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:29Z,,0,0,09000064867f564c
FDA-2022-N-2390-0065,FDA,FDA-2022-N-2390,Proposed Order,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:47Z,,0,0,09000064867f5668
FDA-2022-N-2390-0045,FDA,FDA-2022-N-2390,Cover Memorandum to Commissioner,Other,Memorandum,2024-11-07T05:00:00Z,2024,11,2024-11-07T05:00:00Z,,2024-11-07T18:09:33Z,,0,0,09000064867f561b
FDA-2022-N-2390-0055,FDA,FDA-2022-N-2390,ICSD 3 3rd edition 2014 Insomnia,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:19:57Z,,0,0,09000064867f5630
FDA-2022-N-2390-0063,FDA,FDA-2022-N-2390,Letter from FDA CDER to Patel,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:39Z,,0,0,09000064867f5650
FDA-2022-N-2390-0058,FDA,FDA-2022-N-2390,Letter from FDA CDER to Liew,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:15Z,,0,0,09000064867f5636
FDA-2022-N-2390-0052,FDA,FDA-2022-N-2390,Letter from FDA CDER to Harvey,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:19:40Z,,0,0,09000064867f562a
FDA-2022-N-2390-0057,FDA,FDA-2022-N-2390,Letter from FDA CDER to Levenson,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:10Z,,0,0,09000064867f5634
FDA-2022-N-2390-0051,FDA,FDA-2022-N-2390,Letter from FDACDER to Flaxman,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:19:36Z,,0,0,09000064867f5628
FDA-2022-N-2390-0049,FDA,FDA-2022-N-2390,Letter from FDA CDER to Basta,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:19:26Z,,0,0,09000064867f560b
FDA-2022-N-2390-0062,FDA,FDA-2022-N-2390,Letter from FDA CDER to Okajima,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:34Z,,0,0,09000064867f564e
FDA-2022-N-2390-0050,FDA,FDA-2022-N-2390,Letter from FDA CDER to Ellis,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:19:30Z,,0,0,09000064867f5624
FDA-2022-N-2390-0060,FDA,FDA-2022-N-2390,Letter from FDA CDER to Morin,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:25Z,,0,0,09000064867f564a
FDA-2022-N-2390-0066,FDA,FDA-2022-N-2390,Letter from FDA CDER to Rezaie,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:20:52Z,,0,0,09000064867f566a
FDA-2022-N-2390-0053,FDA,FDA-2022-N-2390,Letter from FDA CDER to Hernan,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:19:46Z,,0,0,09000064867f562c
FDA-2022-N-2390-0054,FDA,FDA-2022-N-2390,Letter from FDA CDER to Hiller,Supporting & Related Material,Background Material,2024-11-07T05:00:00Z,2024,11,,,2024-11-07T18:19:51Z,,0,0,09000064867f562e