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573 rows where docket_id = "FDA-2022-N-2390" sorted by posted_date descending
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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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;