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withdrawn,object_id FDA-2022-N-2390-0360,FDA,FDA-2022-N-2390,"Exhibit 38 - FDA Non-24 Letter (Jan. 27, 2020)",Supporting & Related Material,Background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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,FDA-2022-N-2390,Exhibit 141 - Rest. 2d Contracts ยง 17,Supporting & Related Material,Background Material,2022-12-12T05:00:00Z,2022,12,,,2025-04-04T18:20:53Z,,0,0,09000064869cacde