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withdrawn,object_id FDA-2022-N-2390-0097,FDA,FDA-2022-N-2390,Exhibit 208,Supporting & Related Material,Background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 FDA-2022-N-2390-0044,FDA,FDA-2022-N-2390,Letter from FDA OC to Vanda Pharmaceuticals Inc. and FDA CDER,Other,Letter(s),2024-10-07T04:00:00Z,2024,10,2024-10-07T04:00:00Z,,2024-10-07T18:34:55Z,,0,0,09000064867b63e8 FDA-2022-N-2390-0043,FDA,FDA-2022-N-2390,Response from Vanda Pharmaceuticals Inc. re Scheduling for Vanda’s Hearing on Proposal to Refuse to Approve a New Drug Application Supplement for HETLIOZ,Other,Response(s),2024-09-24T04:00:00Z,2024,9,2024-09-24T04:00:00Z,,2024-09-24T20:36:51Z,,0,0,090000648677baba FDA-2022-N-2390-0042,FDA,FDA-2022-N-2390,Scheduling for Vanda’s Hearing on Proposal to Refuse to Approve a New Drug Application Supplement for HETLIOZ (tasimelteon),Other,Letter(s),2024-09-10T04:00:00Z,2024,9,2024-09-10T04:00:00Z,,2024-09-10T20:40:25Z,,0,0,09000064866e4df2 FDA-2022-N-2390-0041,FDA,FDA-2022-N-2390,Memorandum - Separation of Functions; Proposal to Refuse to Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon) (sNDA 205677-012),Other,Memorandum,2024-09-04T04:00:00Z,2024,9,2024-09-04T04:00:00Z,,2024-09-04T16:14:53Z,,0,0,09000064866c0cf3 FDA-2022-N-2390-0141,FDA,FDA-2022-N-2390,Exhibit 5,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T15:25:11Z,,0,0,090000648697242f FDA-2022-N-2390-0142,FDA,FDA-2022-N-2390,Exhibit 6,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T15:33:03Z,,0,0,0900006486972430 FDA-2022-N-2390-0145,FDA,FDA-2022-N-2390,Exhibit 9,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T15:33:18Z,,0,0,0900006486972434 FDA-2022-N-2390-0151,FDA,FDA-2022-N-2390,Exhibit 15,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T15:34:28Z,,0,0,090000648697245c FDA-2022-N-2390-0162,FDA,FDA-2022-N-2390,Exhibit 26,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T15:54:22Z,,0,0,0900006486972485 FDA-2022-N-2390-0166,FDA,FDA-2022-N-2390,Exhibit 30,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T15:54:45Z,,0,0,09000064869759f7 FDA-2022-N-2390-0171,FDA,FDA-2022-N-2390,Exhibit 35,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T15:55:36Z,,0,0,09000064869757af FDA-2022-N-2390-0195,FDA,FDA-2022-N-2390,Exhibit 59,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T16:30:22Z,,0,0,090000648697663d FDA-2022-N-2390-0211,FDA,FDA-2022-N-2390,Exhibit 75,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T16:32:34Z,,0,0,090000648697683e FDA-2022-N-2390-0220,FDA,FDA-2022-N-2390,Exhibit 84,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T16:34:11Z,,0,0,09000064869768ff FDA-2022-N-2390-0228,FDA,FDA-2022-N-2390,Exhibit 92,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T16:35:43Z,,0,0,0900006486976977 FDA-2022-N-2390-0262,FDA,FDA-2022-N-2390,Exhibit 126,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T17:04:05Z,,0,0,0900006486976fdf FDA-2022-N-2390-0257,FDA,FDA-2022-N-2390,Exhibit 121,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T17:03:05Z,,0,0,0900006486976f49 FDA-2022-N-2390-0200,FDA,FDA-2022-N-2390,Exhibit 64,Supporting & Related Material,Background Material,2024-08-06T04:00:00Z,2024,8,,,2025-04-04T16:31:08Z,,0,0,09000064869766e9