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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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18 rows where docket_id = "FDA-2007-N-0475" sorted by posted_date descending

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posted_year 6

document_type 2

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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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;