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

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30 rows where docket_id = "FDA-2010-N-0381" sorted by posted_date descending

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posted_year 3

document_type 3

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-N-0381-0057 FDA None FDA-2010-N-0381 Nostrum Pharmaceuticals, LLC - Letter Other Letter(s) 2012-09-23T04:00:00Z 2012 9 2012-09-23T04:00:00Z   2012-09-23T16:07:18Z   0 0 0900006480fdb963
FDA-2010-N-0381-0051 FDA None FDA-2010-N-0381 Meetings: Generic Drug User Fee; Correction Notice General Notice 2011-12-21T05:00:00Z 2011 12 2011-12-21T05:00:00Z   2011-12-21T22:13:01Z 2011-32562 0 0 0900006480f870d0
FDA-2010-N-0381-0048 FDA None FDA-2010-N-0381 Generic Drug User Fee; Public Meeting Notice Meeting 2011-12-08T05:00:00Z 2011 12 2011-12-08T05:00:00Z 2012-01-07T04:59:59Z 2011-12-08T14:13:25Z 2011-31630 0 0 0900006480f7df83
FDA-2010-N-0381-0046 FDA None FDA-2010-N-0381 Generic Drug User Fee; Request for Comments Notice Meeting 2011-07-22T04:00:00Z 2011 7 2011-07-22T04:00:00Z 2011-09-27T03:59:59Z 2011-07-22T15:06:10Z 2011-18591 0 0 0900006480ec9599
FDA-2010-N-0381-0042 FDA None FDA-2010-N-0381 Generic Drug User Fee; Extension of Comment Period Notice NEC-Notice of Extension 2011-06-08T04:00:00Z 2011 6 2011-06-08T04:00:00Z 2011-08-02T03:59:59Z 2011-06-08T16:37:43Z 2011-14120 0 0 0900006480e40148
FDA-2010-N-0381-0041 FDA None FDA-2010-N-0381 Generic Drug User Fee; Public Meeting; Request for Comments Notice N-Notice 2011-04-29T04:00:00Z 2011 4 2011-04-29T04:00:00Z 2011-06-11T03:59:59Z 2011-04-29T14:05:42Z 2011-10382 0 0 0900006480c3bf40
FDA-2010-N-0381-0038 FDA None FDA-2010-N-0381 Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period Notice NEC-Notice of Extension 2011-03-15T04:00:00Z 2011 3 2011-03-15T04:00:00Z 2011-07-01T03:59:59Z 2011-03-18T19:48:31Z 2011-05917 0 0 0900006480c07f7e
FDA-2010-N-0381-0035 FDA None FDA-2010-N-0381 Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period Notice N-Notice 2011-01-24T05:00:00Z 2011 1 2011-01-24T05:00:00Z 2011-02-24T04:59:59Z 2011-02-18T18:59:02Z 2011-01274 0 0 0900006480bd126e
FDA-2010-N-0381-0031 FDA None FDA-2010-N-0381 Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period Notice NEC-Notice of Extension 2010-11-04T04:00:00Z 2010 11 2010-11-04T04:00:00Z 2010-12-07T04:59:59Z 2010-11-22T19:01:39Z 2010-27824 0 0 0900006480b80cae
FDA-2010-N-0381-0029 FDA None FDA-2010-N-0381 See FDA-2010-N-0381-0032 Supporting & Related Material   2010-11-03T00:00:00Z 2010 11     2012-03-24T19:34:22Z   0 1 0900006480b70f32
FDA-2010-N-0381-0030 FDA None FDA-2010-N-0381 See FDA-2010-N-0381-0032 Supporting & Related Material   2010-11-03T00:00:00Z 2010 11     2012-03-24T19:34:29Z   0 1 0900006480b71758
FDA-2010-N-0381-0007 FDA None FDA-2010-N-0381 Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER), Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:04Z   0 0 0900006480b6a6d4
FDA-2010-N-0381-0009 FDA None FDA-2010-N-0381 Brian J. Hasselbalch, Team Leader, Division of Manufacturing and Product Quality, Office of Compliance, CDER, Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:05Z   0 0 0900006480b6a6d6
FDA-2010-N-0381-0011 FDA None FDA-2010-N-0381 Jonah Houts, Alliance for Affordable Medicine, Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:05Z   0 0 0900006480b6a6d8
FDA-2010-N-0381-0013 FDA None FDA-2010-N-0381 Ahaviah Diane Glaser, American Association of Retired Persons (AARP), Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:05Z   0 0 0900006480b6a6da
FDA-2010-N-0381-0015 FDA None FDA-2010-N-0381 William Vaughan, Consumers Union, Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-08-11T01:37:28Z   0 0 0900006480b6a731
FDA-2010-N-0381-0005 FDA None FDA-2010-N-0381 Generic Drug User Fee Act (GDUFA) Attendee Meeting List, September 17, 2010 - List Other LST-List 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:04Z   0 0 0900006480b6a6d2
FDA-2010-N-0381-0018 FDA None FDA-2010-N-0381 K.L. Spear M.D., Spear Pharmaceuticals, Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:06Z   0 0 0900006480b6a736
FDA-2010-N-0381-0016 FDA None FDA-2010-N-0381 Paul Brown, National Research Center(NRC) for Women and Families, Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:05Z   0 0 0900006480b6a732
FDA-2010-N-0381-0019 FDA None FDA-2010-N-0381 Richard J. Stec, Jr., Generic Drug User Fee Coalition Members (Apotex Corp.,Hospira Inc.,Perrigo Company, and Teva Pharmaceuticals USA), Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:05Z   0 0 0900006480b6a734
FDA-2010-N-0381-0021 FDA None FDA-2010-N-0381 Generic Drug User Fee; Public Meeting, September 17, 2010 - Transcript Other TR-Transcript 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:06Z   0 0 0900006480b6a737
FDA-2010-N-0381-0017 FDA None FDA-2010-N-0381 Gordon Johnston, Generic Pharmaceutical Association (GPhA), Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:05Z   0 0 0900006480b6a733
FDA-2010-N-0381-0014 FDA None FDA-2010-N-0381 Kasey Thompson, American Society of Health-Systems Pharmacy (ASHP), Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-08-11T03:11:10Z   0 0 0900006480b6a6db
FDA-2010-N-0381-0006 FDA None FDA-2010-N-0381 Margaret Hamburg, M.D., Commissioner of Food and Drugs, Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:04Z   0 0 0900006480b6a6d3
FDA-2010-N-0381-0008 FDA None FDA-2010-N-0381 Helen N. Winkle, Director, Office of Pharmaceutical Science, CDER, Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-08-11T03:11:09Z   0 0 0900006480b6a6d5
FDA-2010-N-0381-0020 FDA None FDA-2010-N-0381 Mylan Pharmaceuticals (Heather Bresch), Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:06Z   0 0 0900006480b6a735
FDA-2010-N-0381-0012 FDA None FDA-2010-N-0381 Judy Cahill, Academy of Managed Care Pharmacy, Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:05Z   0 0 0900006480b6a6d9
FDA-2010-N-0381-0010 FDA None FDA-2010-N-0381 Peter C. Beckerman, J.D. Senior Policy Advisor, FDA Office of Policy, Generic Drug User Fee; Public Meeting, September 17, 2010 - Presentation Other TS-Testimony 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:05Z   0 0 0900006480b6a6d7
FDA-2010-N-0381-0004 FDA None FDA-2010-N-0381 Generic Drug User Fee; Public Meeting, September 17, 2010 - Agenda Other LST-List 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:04Z   0 0 0900006480b6a501
FDA-2010-N-0381-0001 FDA None FDA-2010-N-0381 Generic Drug User Fee; Public Meeting; Request for Comments Notice NM-Notice of Meeting 2010-08-09T04:00:00Z 2010 8 2010-08-09T04:00:00Z 2010-10-18T03:59:59Z 2010-10-07T21:10:45Z 2010-19537 0 0 0900006480b2c0f9

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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;