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withdrawn,object_id FDA-2020-E-2363-0001,FDA,FDA-2020-E-2363,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:46:23Z,,0,0,09000064849d6369 FDA-2020-E-2364-0002,FDA,FDA-2020-E-2364,"Patent Term Extension Application for NURTEC ODT® Patent No 8,314,117",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:56:21Z,,0,0,09000064849d636f FDA-2020-E-2361-0002,FDA,FDA-2020-E-2361,"Patent Term Extension Application for ENSPRYNG® Patent No 8,562,991",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:33:58Z,,0,0,09000064849d615c FDA-2020-E-2365-0002,FDA,FDA-2020-E-2365,"Patent Term Extension Application for NURTEC ODT® Patent No 8,759,372",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T15:04:43Z,,0,0,09000064849d63e4 FDA-2020-E-2364-0001,FDA,FDA-2020-E-2364,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:55:22Z,,0,0,09000064849d636e FDA-2020-E-2363-0002,FDA,FDA-2020-E-2363,"Patent Term Extension Application for ENSPRYNG® Patent No 10,662,245",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:47:19Z,,0,0,09000064849d636a FDA-2020-P-1769-0011,FDA,FDA-2020-P-1769,Response letter to Siri & Glimstad LLP from FDA CBER,Other,Response(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T18:19:46Z,,0,0,09000064849d6b35 FDA-2020-E-2365-0001,FDA,FDA-2020-E-2365,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T15:03:44Z,,0,0,09000064849d63e3 FDA-2020-E-2362-0001,FDA,FDA-2020-E-2362,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:39:30Z,,0,0,09000064849d615f FDA-2020-E-2362-0002,FDA,FDA-2020-E-2362,"Patent Term Extension Application for ENSPRYNG® Patent No 10,022,319",Other,Application,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:40:22Z,,0,0,09000064849d6366 FDA-2020-E-2361-0001,FDA,FDA-2020-E-2361,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:33:04Z,,0,0,09000064849d615b FDA-2020-V-2292-0003,FDA,FDA-2020-V-2292,Variance Approval Letter from FDA CDRH to Irani Silva,Other,Approval for Variance (VRA),2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T16:11:07Z,,0,0,09000064849d63ea FDA-2016-N-0124-0411,FDA,FDA-2016-N-0124,"Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability",Other,Guidance,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2024-11-12T23:26:51Z,,1,0,09000064849d6159 APHIS-2020-0077-0050,APHIS,APHIS-2020-0077,"Finding of No Significant Impact and Decision for the Environmental Assessment: Predator Damage and Conflict Management in Wyoming, December 2020",Other,Decision,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T14:35:17Z,,0,0,09000064849d1019 APHIS-2020-0077-0049,APHIS,APHIS-2020-0077,"Final Environmental Assessment: Predator Damage and Conflict Management in Wyoming, December 2020",Other,Environmental assessment,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T14:35:08Z,,0,0,09000064849d1018 APHIS-2020-0127-0001,APHIS,APHIS-2020-0127,"Draft Environmental Assessment: Managing Damage and Threats of Damaged Caused by Birds in Oklahoma, December 2020",Other,Environmental assessment,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,2021-02-16T04:59:59Z,2021-02-16T02:00:46Z,,0,0,09000064849d263d FDA-2015-P-0703-0003,FDA,FDA-2015-P-0703,Citizen Petition Response to Sarah Salem-Robinson,Other,Response(s),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T16:53:12Z,,0,0,09000064849d2636 FDA-2020-V-2282-0003,FDA,FDA-2020-V-2282,Variance Approval Letter from FDA CDRH to MicaTronics LLC,Other,Approval for Variance (VRA),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T16:33:49Z,,0,0,09000064849d20ba FDA-2018-P-2073-0005,FDA,FDA-2018-P-2073,Citizen Petition Response to LMS Direct Research Foundation,Other,Response(s),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T17:00:45Z,,0,0,09000064849d22af FDA-2020-P-2360-0001,FDA,FDA-2020-P-2360,Citizen Petition from Pet Schooled The Educated Community,Other,Citizen Petition,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2024-11-12T23:26:46Z,,1,0,09000064849d0890 FDA-2020-P-2357-0001,FDA,FDA-2020-P-2357,"Citizen Petition from Keller and Heckman LLP on behalf of Nexira, Alland & Robert and Importers Service Corporation",Other,Citizen Petition,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2021-12-17T13:56:39Z,,0,0,09000064849ce2e5 FDA-2020-P-2357-0002,FDA,FDA-2020-P-2357,"Acknowledgment Letter from FDA DMS to Keller and Heckman LLP n behalf of Nexira, Alland & Robert, and Importers Service Corporation",Other,Acknowledgement Letter/Receipt,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T13:41:28Z,,0,0,09000064849ce2e6 FDA-2020-P-2360-0002,FDA,FDA-2020-P-2360,Acknowledgment Letter from FDA DMS to Pet Schooled,Other,Acknowledgement Letter/Receipt,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2024-11-12T23:26:29Z,,1,0,09000064849d20b5 FDA-2016-P-1398-0004,FDA,FDA-2016-P-1398,Citizen Petition Response to Dr. Hooman Noorchashm,Other,Response(s),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T17:01:11Z,,0,0,09000064849d263b FDA-2018-P-3843-0115,FDA,FDA-2018-P-3843,Citizen Petition Response to Hoomad Noorchashm,Other,Response(s),2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2020-12-30T17:06:07Z,,0,0,09000064849d22b1 FDA-2014-D-1804-0074,FDA,FDA-2014-D-1804,"Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff",Other,Guidance,2020-12-30T05:00:00Z,2020,12,2020-12-30T05:00:00Z,,2024-11-12T23:26:46Z,,1,0,09000064849d088d APHIS-2020-0125-0001,APHIS,APHIS-2020-0125,"Draft Environmental Assessment: Managing Damage and Threats of Damage caused by Birds in the State of North Dakota, December 2020",Other,Environmental assessment,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,2021-02-09T04:59:59Z,2021-02-10T02:00:36Z,,0,0,09000064849cf4c7 EPA-HQ-OPP-2015-0433-0044,EPA,EPA-HQ-OPP-2015-0433,Thiram.Ferbam.Ziram.DRA 15-Day Extension,Other,,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-30T01:42:10Z,,0,0,0900006484990264 EPA-HQ-OPP-2013-0156-0038,EPA,EPA-HQ-OPP-2013-0156,Propylene Oxide PID 30-Day Comment Extension,Other,,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-30T01:35:25Z,,0,0,09000064849a09cc EPA-HQ-OPP-2014-0004-0098,EPA,EPA-HQ-OPP-2014-0004,Comment Period Extension for Thiophanate Methyl and Carbendazim (TM MBC),Other,,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-30T01:39:38Z,,0,0,09000064849a9b41 FDA-2020-V-2356-0001,FDA,FDA-2020-V-2356,Variance Application from La Farm Animal Save,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T16:42:59Z,,0,0,09000064849cd180 FDA-2020-V-2356-0002,FDA,FDA-2020-V-2356,Acknowledgment Letter from FDA DMS to La Farm Animal Save,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T16:46:33Z,,0,0,09000064849cd7a6 FDA-2020-V-2350-0001,FDA,FDA-2020-V-2350,Variance Application from Jurijus Voronovas,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T14:41:00Z,,0,0,09000064849cb3a9 FDA-2020-V-2346-0002,FDA,FDA-2020-V-2346,Acknowledgment Letter from FDA DMS to Jayden Romay Ruiz,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:15:26Z,,0,0,09000064849cbcad FDA-2020-V-2347-0001,FDA,FDA-2020-V-2347,Variance Application from Silverhawk Aviation,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:11:33Z,,0,0,09000064849cbd6b FDA-2020-V-2350-0002,FDA,FDA-2020-V-2350,Acknowledgment Letter from FDA DMS to Jurijus Voronovas,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T14:46:47Z,,0,0,09000064849cbccc FDA-2020-V-2345-0002,FDA,FDA-2020-V-2345,Acknowledgment Letter from FDA DMS to Shane Cassidy,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T15:06:38Z,,0,0,09000064849cb3a5 FDA-2020-V-2347-0002,FDA,FDA-2020-V-2347,Acknowledgement Letter from FDA DMS to Silverhawk Aviation,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:11:47Z,,0,0,09000064849cbd71 FDA-2020-V-2346-0001,FDA,FDA-2020-V-2346,Variance Application from Jayden Romay Ruiz,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:15:10Z,,0,0,09000064849cb9a4 FDA-2020-P-1633-0005,FDA,FDA-2020-P-1633,"Interim Response Letter from FDA CBER to Foley Hoag, LLP (on behalf of the Microbiome Therapeutics Innovation Group)",Other,Letter(s),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T20:33:10Z,,0,0,09000064849d0105 FDA-2020-D-1825-0015,FDA,FDA-2020-D-1825,Investigational COVID-19 Convalescent Plasma Guidance for Industry,Other,Guidance,2020-12-29T05:00:00Z,2020,12,2021-01-04T05:00:00Z,,2024-11-06T23:44:24Z,,1,0,09000064849dc6c4 FDA-2020-V-2344-0002,FDA,FDA-2020-V-2344,Acknowledgment Letter from FDA DMS to Joshua Coonradt,Other,Acknowledgement Letter/Receipt,2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:17:52Z,,0,0,09000064849cb386 FDA-2020-V-2345-0001,FDA,FDA-2020-V-2345,Variance Application from Shane Cassidy,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T15:02:00Z,,0,0,09000064849cb27f FDA-2020-V-2344-0001,FDA,FDA-2020-V-2344,Variance Application from Joshua Coonradt,Other,Application for Variance (VAR),2020-12-29T05:00:00Z,2020,12,2020-12-29T05:00:00Z,,2020-12-29T18:17:30Z,,0,0,09000064849cb2cb EPA-HQ-OPP-2017-0653-0004,EPA,EPA-HQ-OPP-2017-0653,Public Participation for Picarbutrazox,Other,Public Participation,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,2021-01-14T04:59:59Z,2021-01-20T02:01:42Z,,0,0,09000064849cb9aa EPA-HQ-OAR-2019-0307-0088,EPA,EPA-HQ-OAR-2019-0307,FDMS Posting Memo-FRM,Other,,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-29T01:33:28Z,,0,0,09000064849cda08 FDA-2020-V-2321-0002,FDA,FDA-2020-V-2321,Acknowledgment Letter from FDA DMS to Zachary Taylor,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T14:40:16Z,,0,0,09000064849bb5e2 FDA-2020-V-2348-0002,FDA,FDA-2020-V-2348,Acknowledgment Letter from FDA DMS to Below the Waves LLC,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:41:48Z,,0,0,09000064849cb2cd FDA-2020-V-2348-0001,FDA,FDA-2020-V-2348,Variance Application from Below the Waves LLC,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:40:51Z,,0,0,09000064849cb2c9 FDA-2020-V-2352-0001,FDA,FDA-2020-V-2352,Variance Application from Gregory Class,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T20:18:43Z,,0,0,09000064849cbe4d FDA-2020-V-2349-0001,FDA,FDA-2020-V-2349,Variance Application from John Nelson,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:42:29Z,,0,0,09000064849cb380 FDA-2020-V-2351-0002,FDA,FDA-2020-V-2351,Acknowledgment Letter from FDA DMS to One Source Media Solutions,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:49:56Z,,0,0,09000064849cbd6f FDA-2020-V-2321-0001,FDA,FDA-2020-V-2321,Variance Application from Zachary Taylor,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T14:39:34Z,,0,0,09000064849bb5df FDA-2020-V-2352-0002,FDA,FDA-2020-V-2352,Acknowledgment Letter from FDA DMS to Gregory Class,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T20:20:57Z,,0,0,09000064849ccac9 FDA-2020-V-2351-0001,FDA,FDA-2020-V-2351,Variance Application from One Source Media Solutions,Other,Application for Variance (VAR),2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:49:04Z,,0,0,09000064849cbd6d FDA-2020-V-2349-0002,FDA,FDA-2020-V-2349,Acknowledgment Letter from FDA DMS to John Nelson,Other,Acknowledgement Letter/Receipt,2020-12-28T05:00:00Z,2020,12,2020-12-28T05:00:00Z,,2020-12-28T21:48:27Z,,0,0,09000064849cb383 EPA-HQ-OPP-2018-0551-0007,EPA,EPA-HQ-OPP-2018-0551,Public Participation of New Active Ingredient Fluindapyr,Other,,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,2021-01-23T04:59:59Z,2021-02-03T02:00:42Z,,0,0,09000064849c4769 FDA-2020-E-2337-0001,FDA,FDA-2020-E-2337,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:31:44Z,,0,0,09000064849c11a1 FDA-2020-E-2337-0002,FDA,FDA-2020-E-2337,"Patent Term Extension Application for ROZLYTREK® Patent No 9,085,565",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:32:55Z,,0,0,09000064849c11a2 FDA-2020-V-2320-0002,FDA,FDA-2020-V-2320,Acknowledgment Letter from FDA DMS to Neil Hotkiewicz,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T12:49:14Z,,0,0,09000064849bb5dc FDA-2020-P-2008-0006,FDA,FDA-2020-P-2008,Interim Response Letter from FDA CDRH to Philips Respironics,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T14:06:37Z,,0,0,09000064849c1209 FDA-2020-V-2342-0002,FDA,FDA-2020-V-2342,Acknowledgment Letter from FDA DMS to Chris Cook,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T20:25:34Z,,0,0,09000064849c2508 FDA-2020-V-2341-0001,FDA,FDA-2020-V-2341,Variance Application from FiveAM Theater,Other,Application for Variance (VAR),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T19:21:30Z,,0,0,09000064849c2113 FDA-2020-V-2188-0003,FDA,FDA-2020-V-2188,Variance Approval Letter from FDA CDRH to SONY Corporation,Other,Approval for Variance (VRA),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T14:57:35Z,,0,0,09000064849c120d FDA-2020-E-2334-0002,FDA,FDA-2020-E-2334,"Patent Term Extension Application for ROZLYTREK® Patent No 8,673,893",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:10:17Z,,0,0,09000064849c0c38 FDA-2020-E-2338-0001,FDA,FDA-2020-E-2338,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:38:21Z,,0,0,09000064849c11a5 FDA-2020-V-2342-0001,FDA,FDA-2020-V-2342,Variance Application from Chris Cook,Other,Application for Variance (VAR),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T20:24:51Z,,0,0,09000064849c211b FDA-2020-E-2334-0001,FDA,FDA-2020-E-2334,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:09:00Z,,0,0,09000064849c0c37 FDA-2020-V-2320-0001,FDA,FDA-2020-V-2320,Variance Application from Neil Hotkiewicz,Other,Application for Variance (VAR),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T12:46:17Z,,0,0,09000064849b9020 FDA-2020-E-2333-0001,FDA,FDA-2020-E-2333,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:01:31Z,,0,0,09000064849c0a4b FDA-2020-V-2343-0002,FDA,FDA-2020-V-2343,Acknowledgment Letter from FDA DMS to Ben Black,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T19:24:59Z,,0,0,09000064849c142f FDA-2020-D-1136-0044,FDA,FDA-2020-D-1136,Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry,Other,Guidance,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,2023-05-12T03:59:59Z,2023-05-08T19:02:22Z,,0,0,09000064849bcedf FDA-2020-E-2335-0001,FDA,FDA-2020-E-2335,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:15:28Z,,0,0,09000064849c1160 FDA-2020-E-2336-0001,FDA,FDA-2020-E-2336,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:22:21Z,,0,0,09000064849c1164 FDA-2020-P-2010-0007,FDA,FDA-2020-P-2010,Interim Response Letter from FDA CDRH to Philips Respironics,Other,Letter(s),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T14:01:45Z,,0,0,09000064849c1206 FDA-2020-P-2322-0002,FDA,FDA-2020-P-2322,Acknowledgment Letter from FDA DMS to Covington & Burling LLP on behalf of Pharmaceutical Research and Manufacturers of America,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:43:35Z,,0,0,09000064849bae17 FDA-2020-E-2336-0002,FDA,FDA-2020-E-2336,"Patent Term Extension Application for ROZLYTREK® Patent No 9,029,356",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:25:27Z,,0,0,09000064849c1165 FDA-2020-E-2338-0002,FDA,FDA-2020-E-2338,"Patent Term Extension Application for ROZLYTREK® Patent No 9,085,565",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:39:55Z,,0,0,09000064849c11a6 FDA-2020-V-2205-0004,FDA,FDA-2020-V-2205,"Variance Approval Letter from FDA CDRH to MultiMedia Consulting Services, Inc",Other,Approval for Variance (VRA),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T21:09:03Z,,0,0,09000064849c5891 FDA-2020-E-2333-0002,FDA,FDA-2020-E-2333,"Patent Term Extension Application for ROZLYTREK® Patent No 8,299,057",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:02:47Z,,0,0,09000064849c0a4c FDA-2020-E-2335-0002,FDA,FDA-2020-E-2335,"Patent Term Extension Application for ROZLYTREK® Patent No 9,029,356",Other,Application,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T13:16:33Z,,0,0,09000064849c1161 FDA-2017-D-4303-0002,FDA,FDA-2017-D-4303,Guidance for Industry REMS.eSub,Other,Guidance,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2024-11-12T23:27:37Z,,1,0,09000064849c3775 FDA-2020-V-2343-0001,FDA,FDA-2020-V-2343,Variance Application from Ben Black,Other,Application for Variance (VAR),2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T19:23:13Z,,0,0,09000064849c142c FDA-2020-V-2341-0002,FDA,FDA-2020-V-2341,Acknowledgment Letter from FDA DMS to FiveAM Theater,Other,Acknowledgement Letter/Receipt,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2020-12-23T19:22:09Z,,0,0,09000064849c2114 FDA-2020-P-2322-0001,FDA,FDA-2020-P-2322,Citizen Petition from Covington & Burling LLP on behalf of Pharmaceutical Research and Manufacturers of America,Other,Citizen Petition,2020-12-23T05:00:00Z,2020,12,2020-12-23T05:00:00Z,,2024-11-12T23:26:39Z,,1,0,09000064849bae16 EPA-HQ-OAR-2019-0307-0084,EPA,EPA-HQ-OAR-2019-0307,FDMS posting memo,Other,Memorandum to Open a Docket,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,2021-03-02T04:59:59Z,2020-12-23T01:33:43Z,,0,0,09000064849b9018 FDA-2020-P-2317-0001,FDA,FDA-2020-P-2317,Citizen Petition from Baxter Healthcare Corporation,Other,Citizen Petition,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2024-11-12T23:27:19Z,,1,0,09000064849b07a7 FDA-2020-V-2198-0003,FDA,FDA-2020-V-2198,Variance Approval Letter from CDRH to Old Dominion University,Other,Approval for Variance (VRA),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T14:48:03Z,,0,0,09000064849b7b8d FDA-2020-E-2325-0002,FDA,FDA-2020-E-2325,"Patent Term Extension Application for ROZLYTREK® Patent No 8,299,057",Other,Application,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T21:17:46Z,,0,0,09000064849bd25b FDA-2020-P-2318-0001,FDA,FDA-2020-P-2318,"Suitability Citizen Petition from Lachman Consulting Services, Inc.",Other,Petition(s),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2024-11-12T23:26:39Z,,1,0,09000064849b0718 FDA-2020-P-2318-0002,FDA,FDA-2020-P-2318,"Acknowledgement Letter from FDA DMS to Lachman Consulting Services, Inc.",Other,Acknowledgement Letter/Receipt,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T15:18:53Z,,0,0,09000064849b1603 FDA-2020-P-2317-0002,FDA,FDA-2020-P-2317,Acknowledgment Letter from FDA DMS to Baxter Healthcare Corporation,Other,Acknowledgement Letter/Receipt,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T20:00:11Z,,0,0,09000064849b07aa FDA-2020-E-2326-0001,FDA,FDA-2020-E-2326,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T21:26:26Z,,0,0,09000064849bd2d6 FDA-2020-E-2325-0001,FDA,FDA-2020-E-2325,Letter from U S Patent and Trademark Office,Other,Letter(s),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T21:28:14Z,,0,0,09000064849bd25a FDA-2020-V-2278-0003,FDA,FDA-2020-V-2278,Variance Approval from CDRH to Daniel Speicher,Other,Approval for Variance (VRA),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T14:41:41Z,,0,0,09000064849b779a FDA-2020-E-2326-0002,FDA,FDA-2020-E-2326,"Patent Term Extension Application for ROZLYTREK® Patent No 8,673,893",Other,Application,2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T21:27:34Z,,0,0,09000064849bd2d7 FDA-2020-V-2290-0003,FDA,FDA-2020-V-2290,Variance Approval from CDRH to Greg Davis,Other,Approval for Variance (VRA),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T14:44:32Z,,0,0,09000064849b779d FDA-2020-V-2286-0003,FDA,FDA-2020-V-2286,Variance Approval from CDRH to Justin DeJohn,Other,Approval for Variance (VRA),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T14:37:33Z,,0,0,09000064849b7798 FDA-2020-N-2002-0001,FDA,FDA-2020-N-2002,NOOH Letter from the FDA ORA to Thomas J. Whalen,Other,Letter(s),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T20:46:43Z,,0,0,09000064849bced7 FDA-2020-V-2284-0003,FDA,FDA-2020-V-2284,Variance Approval from CDRH to Jeff Esposito,Other,Approval for Variance (VRA),2020-12-22T05:00:00Z,2020,12,2020-12-22T05:00:00Z,,2020-12-22T14:33:47Z,,0,0,09000064849b76c8