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withdrawn,object_id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-2007-N-0475-0040,FDA,FDA-2007-N-0475,"Response Letter from Office of the Commissioner Acting Chief Scientist to FDA/CDER and Shire Development, Inc., re Midodrine Amendment August 25, 2014",Other,Letter(s),2014-09-19T04:00:00Z,2014,9,2014-09-19T04:00:00Z,,2014-09-19T12:52:35Z,,0,0,090000648187ddc9
FDA-2007-N-0475-0039,FDA,FDA-2007-N-0475,"Amendment to Joint Agreement from FDA/CDER and Shire Development, Inc. to the FDA Commissioner  re Midodrine Amendment August 25, 2014",Other,Memo,2014-08-26T04:00:00Z,2014,8,2014-08-26T04:00:00Z,,2014-08-26T18:14:47Z,,0,0,0900006481846556
FDA-2007-N-0475-0037,FDA,FDA-2007-N-0475,"FDA/OC Letter  to Parties from the Office of the Commissioner, dated January 23, 2012 - Letter",Other,Letter(s),2012-01-24T05:00:00Z,2012,1,2012-01-24T05:00:00Z,,2012-01-24T14:27:48Z,,0,0,0900006480fa252a
FDA-2007-N-0475-0036,FDA,FDA-2007-N-0475,"FDA/CDRH/OGC to G. Mathews Warren, Senior Regulatory Counsel, Response to December 15, 2011 - Letter",Other,Letter(s),2012-01-13T05:00:00Z,2012,1,2012-01-13T05:00:00Z,,2012-01-13T19:52:43Z,,0,0,0900006480f96196
FDA-2007-N-0475-0035,FDA,FDA-2007-N-0475,"FDA/OC  to Parties, from the Office of the Commissioner,  December 15, 2011 - Letter",Other,Letter(s),2011-12-22T05:00:00Z,2011,12,2011-12-22T05:00:00Z,,2011-12-22T18:45:27Z,,0,0,0900006480f88195
FDA-2007-N-0475-0034,FDA,FDA-2007-N-0475,"FDA/CDER and Shire Development, Inc. to Margaret A. Hamburg, M.D., FDA Commissioner - Propose to Hold in Abeyance CDER's August 16, 2010 Notice of Opportunity for Hearing - Memo",Other,Memo,2011-12-06T05:00:00Z,2011,12,2011-12-06T05:00:00Z,,2011-12-06T14:44:31Z,,0,0,0900006480f7c4c2
FDA-2007-N-0475-0033,FDA,FDA-2007-N-0475,"FDA/Office of the Commissioner Response to the Parties re: Process, October 13, 2011 - Letter",Other,Letter(s),2011-10-13T04:00:00Z,2011,10,2011-10-13T04:00:00Z,,2011-10-13T15:54:07Z,,0,0,0900006480f516a4
FDA-2007-N-0475-0028,FDA,FDA-2007-N-0475,"Attachment 1 - ""Post Hoc Analysis of Studies SPD426-401 and SPD426-404"" - [Shire Pharmaceuticals - Information and Data] re FDA-2007-N-0475-0027",Supporting & Related Material,INFO-Information (Supporting and Related Material),2010-10-04T04:00:00Z,2010,10,,,2010-10-04T23:48:45Z,,0,0,0900006480b64871
FDA-2007-N-0475-0030,FDA,FDA-2007-N-0475,"Attachment 4 - ""Edward Nieshoff, MD - Correspondence"" - [Shire Pharmaceuticals - Comment] re FDA-2007-N-0475-0027",Supporting & Related Material,C-Comment (Supporting and Related Material),2010-10-04T04:00:00Z,2010,10,,,2010-10-04T23:49:10Z,,0,0,0900006480b648eb
FDA-2007-N-0475-0029,FDA,FDA-2007-N-0475,"Attachment 3 - ""Statistical Analysis - Edward Nieshoff, MD - Unpublished Results with Midodrine in Spinal Cord Injury"" - [Shire Pharmaceuticals - Comment] re FDA-2007-N-0475-0027",Supporting & Related Material,C-Comment (Supporting and Related Material),2010-10-04T04:00:00Z,2010,10,,,2010-10-04T23:49:08Z,,0,0,0900006480b648e9
FDA-2007-N-0475-0019,FDA,FDA-2007-N-0475,Proposal to Withdraw Marketing Approval/Notice of Opportunity for Hearing - Letter,Other,LET-Letter,2010-08-16T04:00:00Z,2010,8,2010-09-14T04:00:00Z,,2016-01-30T20:41:02Z,,0,0,0900006480b31b83
FDA-2007-N-0475-0016,FDA,FDA-2007-N-0475,FDA to Midodrine Application Holder - Letter,Other,LET-Letter,2009-08-13T04:00:00Z,2009,8,2009-08-13T04:00:00Z,,2009-08-13T19:55:28Z,,0,0,0900006480a08695
FDA-2007-N-0475-0017,FDA,FDA-2007-N-0475,"FDA to Mylan Pharmaceuticals, Inc. - Letter",Other,LET-Letter,2009-08-13T04:00:00Z,2009,8,2009-08-13T04:00:00Z,,2009-08-13T19:55:29Z,,0,0,0900006480a08fbf
FDA-2007-N-0475-0018,FDA,FDA-2007-N-0475,FDA to Midodrine Application Holder - Letter,Other,LET-Letter,2009-08-13T04:00:00Z,2009,8,2009-08-13T04:00:00Z,,2009-08-13T19:55:31Z,,0,0,0900006480a08fe1
FDA-2007-N-0475-0015,FDA,FDA-2007-N-0475,"Mylan Pharmaceuticals, Inc. (Mylan) - Letter",Other,LET-Letter,2008-12-31T05:00:00Z,2008,12,2008-12-31T05:00:00Z,,2008-12-31T20:26:19Z,,0,0,09000064808094ec
FDA-2007-N-0475-0009,FDA,FDA-2007-N-0475,"FDA/CDER/OGD - ""Response to Midodrine Application Holder""  - Letter",Other,LET-Letter,2008-12-31T05:00:00Z,2008,12,2008-12-31T05:00:00Z,,2010-08-31T15:00:44Z,,0,0,0900006480439408
FDA-2007-N-0475-0008,FDA,FDA-2007-N-0475,"FDA/CDER/OGD - ""Dear Midodrine Application Holder"" - Response Letter",Other,LET-Letter,2008-08-18T04:00:00Z,2008,8,2008-08-18T04:00:00Z,,2013-07-27T22:22:26Z,,0,0,09000064806cb34f
FDA-2007-N-0475-0001,FDA,FDA-2007-N-0475,FDA/CDER/OGD Letter,Other,LET-Letter,2008-07-22T04:00:00Z,2008,7,2008-07-22T04:00:00Z,,2008-07-22T19:38:29Z,,0,0,090000648068d770