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

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

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posted_year 5

  • 2024 277
  • 2022 261
  • 2023 17
  • 2025 16
  • 2026 2

document_type 3

  • Supporting & Related Material 530
  • Other 39
  • Notice 4

agency_id 1

  • FDA 573
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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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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