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261 rows where docket_id = "FDA-2022-N-2390" and posted_year = 2022 sorted by posted_date descending
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document_type 3
- Supporting & Related Material 259
- Notice 1
- Other 1
posted_year 1
- 2022 · 261 ✖
agency_id 1
- FDA 261
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2390-0360 | FDA | None FDA-2022-N-2390 | Exhibit 38 - FDA Non-24 Letter (Jan. 27, 2020) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:00:14Z | 0 | 0 | 09000064869bcc97 | |||
| FDA-2022-N-2390-0362 | FDA | None FDA-2022-N-2390 | Exhibit 40 - FDRR II (Sept. 1, 2020) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:00:25Z | 0 | 0 | 09000064869bcc9a | |||
| FDA-2022-N-2390-0415 | FDA | None FDA-2022-N-2390 | Exhibit 94 - Hayakawa (2005) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:13:35Z | 0 | 0 | 09000064869bd376 | |||
| FDA-2022-N-2390-0394 | FDA | None FDA-2022-N-2390 | Exhibit 73 - Coren N Engl J Med (1996) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:10:46Z | 0 | 0 | 09000064869bdbb3 | |||
| FDA-2022-N-2390-0398 | FDA | None FDA-2022-N-2390 | Exhibit 77 - DoD Rep. (2021) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:11:12Z | 0 | 0 | 09000064869bdbb8 | |||
| FDA-2022-N-2390-0403 | FDA | None FDA-2022-N-2390 | Exhibit 82 - Erland (2017) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:12:05Z | 0 | 0 | 09000064869bdd11 | |||
| FDA-2022-N-2390-0380 | FDA | None FDA-2022-N-2390 | Exhibit 59 - Becker (2015) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:05:31Z | 0 | 0 | 09000064869bc067 | |||
| FDA-2022-N-2390-0388 | FDA | None FDA-2022-N-2390 | Exhibit 67 - Cardinali (2009) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:06:41Z | 0 | 0 | 09000064869bd9b5 | |||
| FDA-2022-N-2390-0396 | FDA | None FDA-2022-N-2390 | Exhibit 75 - Coste (2009) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:10:55Z | 0 | 0 | 09000064869bdbb5 | |||
| FDA-2022-N-2390-0361 | FDA | None FDA-2022-N-2390 | Exhibit 39 - FDRR I Denial (Aug. 4, 2020) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:00:19Z | 0 | 0 | 09000064869bcc99 | |||
| FDA-2022-N-2390-0367 | FDA | None FDA-2022-N-2390 | Exhibit 45 - Published NOOH | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:02:01Z | 0 | 0 | 09000064869bcd2d | |||
| FDA-2022-N-2390-0386 | FDA | None FDA-2022-N-2390 | Exhibit 65 - Burgess (2003) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:06:33Z | 0 | 0 | 09000064869bd53d | |||
| FDA-2022-N-2390-0326 | FDA | None FDA-2022-N-2390 | Exhibit 4 - sNDA Efficacy Summary | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:45:34Z | 0 | 0 | 09000064869b9588 | |||
| FDA-2022-N-2390-0339 | FDA | None FDA-2022-N-2390 | Exhibit 17 - 3101 Stat. Analysis Plan | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:47:24Z | 0 | 0 | 09000064869bbfc4 | |||
| FDA-2022-N-2390-0344 | FDA | None FDA-2022-N-2390 | Exhibit 22 - Special Protocol Letter (Feb. 1, 2006) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:48:17Z | 0 | 0 | 09000064869bcad6 | |||
| FDA-2022-N-2390-0333 | FDA | None FDA-2022-N-2390 | Exhibit 11 - Hetlioz SMS (Pediatric) Approval Letter | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:46:24Z | 0 | 0 | 09000064869bbdc2 | |||
| FDA-2022-N-2390-0348 | FDA | None FDA-2022-N-2390 | Exhibit 26 - Type B EOP2 Meeting Minutes (June 15, 2015) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:48:44Z | 0 | 0 | 09000064869bcb8f | |||
| FDA-2022-N-2390-0412 | FDA | None FDA-2022-N-2390 | Exhibit 91 - Golombek (2013) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:13:21Z | 0 | 0 | 09000064869bd372 | |||
| FDA-2022-N-2390-0447 | FDA | None FDA-2022-N-2390 | Exhibit 126 - Miller (2021) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:15:07Z | 0 | 0 | 09000064869ca77b | |||
| FDA-2022-N-2390-0350 | FDA | None FDA-2022-N-2390 | Exhibit 27 - Farchione Email (Aug. 9, 2019) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:59:02Z | 0 | 0 | 09000064869bcb90 | |||
| FDA-2022-N-2390-0519 | FDA | None FDA-2022-N-2390 | Exhibit 198 - Evening Standard | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:48:29Z | 0 | 0 | 09000064869d95bc | |||
| FDA-2022-N-2390-0526 | FDA | None FDA-2022-N-2390 | Exhibit 205 - FDA Demonstrating Substantial Evidence | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:49:27Z | 0 | 0 | 09000064869d9cdb | |||
| FDA-2022-N-2390-0539 | FDA | None FDA-2022-N-2390 | Exhibit 218 - ICD-10 | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:51:21Z | 0 | 0 | 09000064869da38a | |||
| FDA-2022-N-2390-0566 | FDA | None FDA-2022-N-2390 | Exhibit 245 - Rozerem Label | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:56:06Z | 0 | 0 | 09000064869dc2ef | |||
| FDA-2022-N-2390-0570 | FDA | None FDA-2022-N-2390 | Exhibit 249 - Sonata Stat. Rev. | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:56:36Z | 0 | 0 | 09000064869dc2fe | |||
| FDA-2022-N-2390-0449 | FDA | None FDA-2022-N-2390 | Exhibit 128 - Murphy (2017) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:50:13Z | 0 | 0 | 09000064869ca77d | |||
| FDA-2022-N-2390-0533 | FDA | None FDA-2022-N-2390 | Exhibit 212 - FL Drowsy Driving Campaign | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:50:46Z | 0 | 0 | 09000064869da024 | |||
| FDA-2022-N-2390-0568 | FDA | None FDA-2022-N-2390 | Exhibit 247 - Sleep Foundation | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:56:22Z | 0 | 0 | 09000064869dc2fb | |||
| FDA-2022-N-2390-0573 | FDA | None FDA-2022-N-2390 | Exhibit 252 - Tegsedi Approval | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:57:02Z | 0 | 0 | 09000064869dc30d | |||
| FDA-2022-N-2390-0493 | FDA | None FDA-2022-N-2390 | Exhibit 172 - Torres (2022) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:45:39Z | 0 | 0 | 09000064869cd1c4 | |||
| FDA-2022-N-2390-0571 | FDA | None FDA-2022-N-2390 | Exhibit 250 - Suni (2022) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:56:41Z | 0 | 0 | 09000064869dc309 | |||
| FDA-2022-N-2390-0575 | FDA | None FDA-2022-N-2390 | Exhibit 254 - Temple (2018) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:57:15Z | 0 | 0 | 09000064869dc31c | |||
| FDA-2022-N-2390-0490 | FDA | None FDA-2022-N-2390 | Exhibit 169 - Svetnik (2020) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:45:22Z | 0 | 0 | 09000064869ccead | |||
| FDA-2022-N-2390-0502 | FDA | None FDA-2022-N-2390 | Exhibit 185 - Austedo Label | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:46:41Z | 0 | 0 | 09000064869d7daf | |||
| FDA-2022-N-2390-0557 | FDA | None FDA-2022-N-2390 | Exhibit 236 - Nuvigil Label | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:53:48Z | 0 | 0 | 09000064869dc2cb | |||
| FDA-2022-N-2390-0565 | FDA | None FDA-2022-N-2390 | Exhibit 244 - Risperdal Label | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:55:55Z | 0 | 0 | 09000064869dc2ee | |||
| FDA-2022-N-2390-0572 | FDA | None FDA-2022-N-2390 | Exhibit 251 - Sunosi Label | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:56:57Z | 0 | 0 | 09000064869dc30c | |||
| FDA-2022-N-2390-0453 | FDA | None FDA-2022-N-2390 | Exhibit 132 - Parrott (1978) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:19:59Z | 0 | 0 | 09000064869ca83c | |||
| FDA-2022-N-2390-0460 | FDA | None FDA-2022-N-2390 | Exhibit 139 - Recht (1995) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:20:37Z | 0 | 0 | 09000064869ca9fe | |||
| FDA-2022-N-2390-0467 | FDA | None FDA-2022-N-2390 | Exhibit 146 - Rosekind (2000) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:35:46Z | 0 | 0 | 09000064869cace4 | |||
| FDA-2022-N-2390-0487 | FDA | None FDA-2022-N-2390 | Exhibit 166 - Stone (2002) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:44:55Z | 0 | 0 | 09000064869ccea8 | |||
| FDA-2022-N-2390-0338 | FDA | None FDA-2022-N-2390 | Exhibit 16 - 3101 Report | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:47:19Z | 0 | 0 | 09000064869bbfc3 | |||
| FDA-2022-N-2390-0345 | FDA | None FDA-2022-N-2390 | Exhibit 23 - PDUFA Type B EOP2 Meeting Minutes (Apr. 30, 2007) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:48:23Z | 0 | 0 | 09000064869bcad8 | |||
| FDA-2022-N-2390-0324 | FDA | None FDA-2022-N-2390 | Exhibit 2 - sNDA Application | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:45:14Z | 0 | 0 | 09000064869b5ac0 | |||
| FDA-2022-N-2390-0332 | FDA | None FDA-2022-N-2390 | Exhibit 10 - Hetlioz SMS Approval Letter | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:46:19Z | 0 | 0 | 09000064869bbd52 | |||
| FDA-2022-N-2390-0343 | FDA | None FDA-2022-N-2390 | Exhibit 21 - 3203 Report | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:48:06Z | 0 | 0 | 09000064869bcad4 | |||
| FDA-2022-N-2390-0356 | FDA | None FDA-2022-N-2390 | Exhibit 34 - Post-Action Mtg. Presentation (Sept. 30, 2019 | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:59:47Z | 0 | 0 | 09000064869bcc36 | |||
| FDA-2022-N-2390-0354 | FDA | None FDA-2022-N-2390 | Exhibit 31 - Post-Action Mtg. Transcript (Sept. 30, 2019) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:59:33Z | 0 | 0 | 09000064869bcb97 | |||
| FDA-2022-N-2390-0510 | FDA | None FDA-2022-N-2390 | Exhibit 189 - Cardiovascular and Renal Advisory Committee | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:47:27Z | 0 | 0 | 09000064869d7df5 | |||
| FDA-2022-N-2390-0559 | FDA | None FDA-2022-N-2390 | Exhibit 238 - Onpattro Approval | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:54:03Z | 0 | 0 | 09000064869dc2cd | |||
| FDA-2022-N-2390-0544 | FDA | None FDA-2022-N-2390 | Exhibit 223 - Lunesta Stat. Rev. | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:51:56Z | 0 | 0 | 09000064869dc211 | |||
| FDA-2022-N-2390-0561 | FDA | None FDA-2022-N-2390 | Exhibit 240 - Otezla Label | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:54:15Z | 0 | 0 | 09000064869dc2cf | |||
| FDA-2022-N-2390-0492 | FDA | None FDA-2022-N-2390 | Exhibit 171 - Thorpy (2012) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:45:32Z | 0 | 0 | 09000064869cceb0 | |||
| FDA-2022-N-2390-0503 | FDA | None FDA-2022-N-2390 | Exhibit 186 - Belsomra Stat. Rev. | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:46:46Z | 0 | 0 | 09000064869d7db0 | |||
| FDA-2022-N-2390-0527 | FDA | None FDA-2022-N-2390 | Exhibit 206 - FDA Development and Approval | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:49:34Z | 0 | 0 | 09000064869d9cdc | |||
| FDA-2022-N-2390-0504 | FDA | None FDA-2022-N-2390 | Exhibit 179 - Zee (2010) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:46:53Z | 0 | 0 | 09000064869d7d30 | |||
| FDA-2022-N-2390-0506 | FDA | None FDA-2022-N-2390 | Exhibit 181 - Abilify Label | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:47:05Z | 0 | 0 | 09000064869d7d35 | |||
| FDA-2022-N-2390-0520 | FDA | None FDA-2022-N-2390 | Exhibit 199 - FAA Advisory Circular | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:48:38Z | 0 | 0 | 09000064869d95bd | |||
| FDA-2022-N-2390-0532 | FDA | None FDA-2022-N-2390 | Exhibit 211 - FDA Statistical Review Template | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:50:41Z | 0 | 0 | 09000064869da022 | |||
| FDA-2022-N-2390-0536 | FDA | None FDA-2022-N-2390 | Exhibit 215 - Geodon Label | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:51:03Z | 0 | 0 | 09000064869da027 | |||
| FDA-2022-N-2390-0560 | FDA | None FDA-2022-N-2390 | Exhibit 239 - Orilissa Approval | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:54:09Z | 0 | 0 | 09000064869dc2ce | |||
| FDA-2022-N-2390-0413 | FDA | None FDA-2022-N-2390 | Exhibit 92 - Gupta (2016) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:13:26Z | 0 | 0 | 09000064869bd374 | |||
| FDA-2022-N-2390-0401 | FDA | None FDA-2022-N-2390 | Exhibit 80 - DSM-5 | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:11:34Z | 0 | 0 | 09000064869bdc62 | |||
| FDA-2022-N-2390-0363 | FDA | None FDA-2022-N-2390 | Exhibit 41 - FDRR II Denial (Oct. 21, 2020) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:00:32Z | 0 | 0 | 09000064869bcc9d | |||
| FDA-2022-N-2390-0371 | FDA | None FDA-2022-N-2390 | Exhibit 49 - Akerstedt (1990) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:02:33Z | 0 | 0 | 09000064869bcdcb | |||
| FDA-2022-N-2390-0372 | FDA | None FDA-2022-N-2390 | Exhibit 50 - Akerstedt (2005) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:02:37Z | 0 | 0 | 09000064869bcdcd | |||
| FDA-2022-N-2390-0406 | FDA | None FDA-2022-N-2390 | Exhibit 85 - Erman (2011) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:12:31Z | 0 | 0 | 09000064869bd355 | |||
| FDA-2022-N-2390-0480 | FDA | None FDA-2022-N-2390 | Exhibit 159 - Snyder (2021) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:44:05Z | 0 | 0 | 09000064869cb6fc | |||
| FDA-2022-N-2390-0473 | FDA | None FDA-2022-N-2390 | Exhibit 152 - Sack (2010) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:43:35Z | 0 | 0 | 09000064869caf7c | |||
| FDA-2022-N-2390-0477 | FDA | None FDA-2022-N-2390 | Exhibit 156 - Shrivastava (2014) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:43:52Z | 0 | 0 | 09000064869cb24f | |||
| FDA-2022-N-2390-0481 | FDA | None FDA-2022-N-2390 | Exhibit 160 - Soape (2013) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:44:13Z | 0 | 0 | 09000064869cb6fd | |||
| FDA-2022-N-2390-0427 | FDA | None FDA-2022-N-2390 | Exhibit 106 - Kramer (2012) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:17:28Z | 0 | 0 | 09000064869c1a5c | |||
| FDA-2022-N-2390-0441 | FDA | None FDA-2022-N-2390 | Exhibit 120 - Marsh-Richard (2009) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:15:49Z | 0 | 0 | 09000064869c9f5e | |||
| FDA-2022-N-2390-0459 | FDA | None FDA-2022-N-2390 | Exhibit 138 - Ramagoapalan (2014) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:20:33Z | 0 | 0 | 09000064869ca905 | |||
| FDA-2022-N-2390-0482 | FDA | None FDA-2022-N-2390 | Exhibit 161 - Song (2017) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:44:23Z | 0 | 0 | 09000064869cb6fe | |||
| FDA-2022-N-2390-0426 | FDA | None FDA-2022-N-2390 | Exhibit 105 - Kolla (2011) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:17:13Z | 0 | 0 | 09000064869c1a5a | |||
| FDA-2022-N-2390-0437 | FDA | None FDA-2022-N-2390 | Exhibit 116 - Mahoney (2010) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:16:14Z | 0 | 0 | 09000064869c96ae | |||
| FDA-2022-N-2390-0446 | FDA | None FDA-2022-N-2390 | Exhibit 125 - Miley (2016) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:15:12Z | 0 | 0 | 09000064869ca77a | |||
| FDA-2022-N-2390-0428 | FDA | None FDA-2022-N-2390 | Exhibit 107 - Krystal (2016) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:17:33Z | 0 | 0 | 09000064869c8418 | |||
| FDA-2022-N-2390-0407 | FDA | None FDA-2022-N-2390 | Exhibit 86 - Evans (2007) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:12:36Z | 0 | 0 | 09000064869bd356 | |||
| FDA-2022-N-2390-0323 | FDA | None FDA-2022-N-2390 | Exhibit 1 - sNDA Cover Letter | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:45:08Z | 0 | 0 | 09000064869b5abf | |||
| FDA-2022-N-2390-0322 | FDA | None FDA-2022-N-2390 | Index to Appendices | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:45:02Z | 0 | 0 | 09000064869b5abe | |||
| FDA-2022-N-2390-0409 | FDA | None FDA-2022-N-2390 | Exhibit 88 - Flynn-Evans (2016) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:12:59Z | 0 | 0 | 09000064869bd359 | |||
| FDA-2022-N-2390-0364 | FDA | None FDA-2022-N-2390 | Exhibit 42 - Request for Hearing (July 1, 2022) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:00:42Z | 0 | 0 | 09000064869bcc9f | |||
| FDA-2022-N-2390-0414 | FDA | None FDA-2022-N-2390 | Exhibit 93 - Hauty (1965) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:13:31Z | 0 | 0 | 09000064869bd375 | |||
| FDA-2022-N-2390-0395 | FDA | None FDA-2022-N-2390 | Exhibit 74 - Coren Percept Motor Skills (1996) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:10:50Z | 0 | 0 | 09000064869bdbb4 | |||
| FDA-2022-N-2390-0379 | FDA | None FDA-2022-N-2390 | Exhibit 58 - Banerjee (2009) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:05:26Z | 0 | 0 | 09000064869bc066 | |||
| FDA-2022-N-2390-0375 | FDA | None FDA-2022-N-2390 | Exhibit 53 - Arendt (2009) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:04:57Z | 0 | 0 | 09000064869bcdd0 | |||
| FDA-2022-N-2390-0387 | FDA | None FDA-2022-N-2390 | Exhibit 66 - Campbell (2017) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:06:37Z | 0 | 0 | 09000064869bd53e | |||
| FDA-2022-N-2390-0390 | FDA | None FDA-2022-N-2390 | Exhibit 69 - Cho (2001) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:05:58Z | 0 | 0 | 09000064869bdb27 | |||
| FDA-2022-N-2390-0408 | FDA | None FDA-2022-N-2390 | Exhibit 87 - Evans (2010) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:12:41Z | 0 | 0 | 09000064869bd358 | |||
| FDA-2022-N-2390-0416 | FDA | None FDA-2022-N-2390 | Exhibit 95 - Herxheimer (2003) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:13:40Z | 0 | 0 | 09000064869bd378 | |||
| FDA-2022-N-2390-0389 | FDA | None FDA-2022-N-2390 | Exhibit 68 - Chai (2019) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:06:54Z | 0 | 0 | 09000064869bdb25 | |||
| FDA-2022-N-2390-0393 | FDA | None FDA-2022-N-2390 | Exhibit 72 - Claustrat (1992) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:10:40Z | 0 | 0 | 09000064869bdbb2 | |||
| FDA-2022-N-2390-0422 | FDA | None FDA-2022-N-2390 | Exhibit 101 - Katz (2001) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:14:26Z | 0 | 0 | 09000064869c1a56 | |||
| FDA-2022-N-2390-0432 | FDA | None FDA-2022-N-2390 | Exhibit 111 - Laverde-Lopez (2022) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:16:43Z | 0 | 0 | 09000064869c8420 | |||
| FDA-2022-N-2390-0451 | FDA | None FDA-2022-N-2390 | Exhibit 130 - O Donnell (2009) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:19:42Z | 0 | 0 | 09000064869ca781 | |||
| FDA-2022-N-2390-0455 | FDA | None FDA-2022-N-2390 | Exhibit 134 - Poisson (2019) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:20:08Z | 0 | 0 | 09000064869ca840 | |||
| FDA-2022-N-2390-0346 | FDA | None FDA-2022-N-2390 | Exhibit 24 - Type B EOP2 Meeting Minutes (June 26, 2009) | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T17:48:28Z | 0 | 0 | 09000064869bcada | |||
| FDA-2022-N-2390-0462 | FDA | None FDA-2022-N-2390 | Exhibit 141 - Rest. 2d Contracts § 17 | Supporting & Related Material | Background Material | 2022-12-12T05:00:00Z | 2022 | 12 | 2025-04-04T18:20:53Z | 0 | 0 | 09000064869cacde |
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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;