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withdrawn,object_id FDA-2019-E-5389-0007,FDA,FDA-2019-E-5389,Letter from FDA CDER to U.S. Patent and Trademark Office,Other,Letter(s),2022-08-29T04:00:00Z,2022,8,2022-08-29T04:00:00Z,,2022-08-29T16:09:12Z,,0,0,0900006485286663 FDA-2019-E-5389-0006,FDA,FDA-2019-E-5389,Determination of Regulatory Review Period for Purposes of Patent Extension; SUNOSI,Notice,Determinations,2021-11-19T05:00:00Z,2021,11,2021-11-19T05:00:00Z,2022-05-19T03:59:59Z,2021-11-19T16:16:11Z,2021-25297,0,0,0900006484e65e47 FDA-2019-E-5389-0005,FDA,FDA-2019-E-5389,Patent Term Extension Approval letter from FDA CDER,Other,Approval,2021-11-05T04:00:00Z,2021,11,2021-11-05T04:00:00Z,,2021-11-05T15:31:14Z,,0,0,0900006484e24dd2 FDA-2019-E-5389-0004,FDA,FDA-2019-E-5389,Letter from U.S. Patent and Trademark Office to FDA CDER,Other,Letter(s),2021-07-26T04:00:00Z,2021,7,2021-07-26T04:00:00Z,,2021-07-26T16:57:25Z,,0,0,0900006484c0f022 FDA-2019-E-5389-0003,FDA,FDA-2019-E-5389,Letter to U.S. Patent and Trademark Office from FDA CDER,Other,Letter(s),2020-01-07T05:00:00Z,2020,1,2020-01-07T05:00:00Z,,2020-01-07T19:43:23Z,,0,0,0900006484279746 FDA-2019-E-5389-0001,FDA,FDA-2019-E-5389,Letter from U S Patent and Trademark Office,Other,Letter(s),2019-11-14T05:00:00Z,2019,11,2019-11-14T05:00:00Z,,2019-11-14T15:41:43Z,,0,0,0900006484154e5f FDA-2019-E-5389-0002,FDA,FDA-2019-E-5389,Patent Term Extension Application from Jazz Pharmaceuticals Inc,Other,Application,2019-11-14T05:00:00Z,2019,11,2019-11-14T05:00:00Z,,2019-11-14T15:44:57Z,,0,0,0900006484154e60