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34 rows where docket_id = "FDA-2009-P-0597" sorted by posted_date descending

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posted_year 4

  • 2009 31
  • 2010 1
  • 2013 1
  • 2019 1

document_type 2

  • Supporting & Related Material 29
  • Other 5

agency_id 1

  • FDA 34
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-P-0597-0035 FDA None FDA-2009-P-0597 FDA/CDER response to WilmerHale - Petition Partial Denial Other Partial Petition Approval and Denial 2019-01-31T05:00:00Z 2019 1 2019-01-31T05:00:00Z   2019-01-31T13:17:17Z   0 0 0900006483a2b4f4
FDA-2009-P-0597-0033 FDA None FDA-2009-P-0597 GlaxoSmithKline - Supplement Other Supplement (SUP) 2013-09-25T04:00:00Z 2013 9 2013-09-25T04:00:00Z   2013-09-25T17:27:55Z   0 0 09000064813c5bb4
FDA-2009-P-0597-0032 FDA None FDA-2009-P-0597 Interim Response to GlaxoSmithKline (Ropes & Gray LLP) Other LET-Letter 2010-06-09T04:00:00Z 2010 6 2010-06-09T04:00:00Z   2013-08-11T04:40:18Z   0 0 0900006480afef88
FDA-2009-P-0597-0008 FDA None FDA-2009-P-0597 Tab 13/Exhibit 13 - "National Asthma Education and Prevention Program, National Institutes of Health, The NAEPP Expert Panel Report 3, Summary Report 2007: Guidelines for the Diagnosis and Management of Asthma (2007)" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:48Z   0 0 0900006480a6c989
FDA-2009-P-0597-0009 FDA None FDA-2009-P-0597 Tab 15/Exhibit 15 - "American Lung Association, Epidemiology & Statistics Unit, Research Program Services Division, Trends in Asthma Morbidity and Mortality (April 2009)" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:49Z   0 0 0900006480a6c98d
FDA-2009-P-0597-0016 FDA None FDA-2009-P-0597 Tab 29/Exhibit 29 - "Approved Labeling, Prescribing Information, Advair HFA" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:59Z   0 0 0900006480a6caf3
FDA-2009-P-0597-0024 FDA None FDA-2009-P-0597 Tab 57/Exhibit 57 - "PQRI Profile Comparisons Working Group, Minutes of Teleconference on February 16, 2005 " - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:10Z   0 0 0900006480a6cd2b
FDA-2009-P-0597-0026 FDA None FDA-2009-P-0597 Tab 77/Exhibit 77 - "FDA/CDER Response to Hill Dermaceuticals, Inc., March 25, 2009, re Docket NID FDA-2004-P-0215" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material BKG-Background Material 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:13Z   0 0 0900006480a6cdd0
FDA-2009-P-0597-0029 FDA None FDA-2009-P-0597 Tab 81/Exhibit 81 - "What Do Cascade Impaction Measurements Tell Us: In Vitro Aspects, IPAC-RS Conference, November 6-8, 2006" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:19Z   0 0 0900006480a6ce7f
FDA-2009-P-0597-0004 FDA None FDA-2009-P-0597 Tab 7/Exhibit 7 - "Infectious Diseases Society of America to FDA/CDER, November 14, 2007" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:43Z   0 0 0900006480a6c948
FDA-2009-P-0597-0022 FDA None FDA-2009-P-0597 Tab 54/Exhibit 54 - "Thomas, et al., Inhaled Corticosteroids for Asthma: Impact of Practice Level Device Switching on Asthma Controls" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:07Z   0 0 0900006480a6ccd6
FDA-2009-P-0597-0011 FDA None FDA-2009-P-0597 Addendum - "Volume II of III - Table of Exhibits 21-50" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:52Z   0 0 0900006480a6c9a2
FDA-2009-P-0597-0027 FDA None FDA-2009-P-0597 Tab 78/Exhibit 78 - "FDA Response to McGuire Woods LLP, GlaxoSmithKline, Frommer Lawrence & Haug, LLP February 22, 2006" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:15Z   0 0 0900006480a6cdd1
FDA-2009-P-0597-0014 FDA None FDA-2009-P-0597 Tab 27/Exhibit 27 - "Approved Labeling, Prescribing Information, Flovent HFA" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:56Z   0 0 0900006480a6caf0
FDA-2009-P-0597-0017 FDA None FDA-2009-P-0597 Tab 30/Exhibit 30 - "FDA/CDER Response to Alza Corporation, January 28, 2005, re Docket IDs 2004P-0506/CP1, 2004P-0472/CP1,2004P-0540/CP1, and 2004P-340/CP1" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:00Z   0 0 0900006480a6caf4
FDA-2009-P-0597-0019 FDA None FDA-2009-P-0597 Tab 32/Exhibit 32 - "FDA/CDER Response to Wyeth-Ayerst Research, March 1, 1999, re Docket No. 97P-0386/CP1" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material BKG-Background Material 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:03Z   0 0 0900006480a6cb3c
FDA-2009-P-0597-0030 FDA None FDA-2009-P-0597 Tab 84/Exhibit 84 - "Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee and Pediatric Advisory Committee, December 10-11, 2008, Transcript" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:20Z   0 0 0900006480a6cf5e
FDA-2009-P-0597-0031 FDA None FDA-2009-P-0597 Acknowledgement Letter to GlaxoSmithKline Other ACK-Acknowledgement Letter 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z   2013-08-11T03:05:59Z   0 0 0900006480a6dd07
FDA-2009-P-0597-0003 FDA None FDA-2009-P-0597 Tab 1/Exhibit 1 - "FDA/CDER Response to King Pharmaceuticals, July 29, 2009, re Docket IDs FDA-2007-P-0128 and FDA-2009-P-0040" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:41Z   0 0 0900006480a6c930
FDA-2009-P-0597-0005 FDA None FDA-2009-P-0597 Tab 10/Exhibit 10 - "PQRI Meeting Objective and Agenda (February 2005) " - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:44Z   0 0 0900006480a6c985
FDA-2009-P-0597-0007 FDA None FDA-2009-P-0597 Tab 12/Exhibit 12 - "National Vital Statistics, Deaths: Final Data for 2006, Volume 57 Report 14 (2009)" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:47Z   0 0 0900006480a6c988
FDA-2009-P-0597-0010 FDA None FDA-2009-P-0597 Tab 17/Exhibit 17 - "National Institutes of Health, National Heart, Lung, and Blood Institute, Morbidity and Mortality: 2007 Chart Book on Cardiovascular, Lung, and Blood Diseases (2007)" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:51Z   0 0 0900006480a6c99b
FDA-2009-P-0597-0021 FDA None FDA-2009-P-0597 Tab 52/Exhibit 52 - "Approved Labeling, Prescribing and Patient Information, Relenza Diskhaler" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:06Z   0 0 0900006480a6ccd3
FDA-2009-P-0597-0028 FDA None FDA-2009-P-0597 Tab 80/Exhibit 80 - "Clinical Relevance on in Vitro Particle Sizing Data, IPAC-RS Conference, November 6-8, 2006" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:17Z   0 0 0900006480a6ce7a
FDA-2009-P-0597-0006 FDA None FDA-2009-P-0597 Tab 11/Exhibit 11 - "American Lung Association, Epidemiology & Statistics Unit, Research Program Services Division, Trends in Asthma Morbidity and Mortality (2009)" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:45Z   0 0 0900006480a6c986
FDA-2009-P-0597-0020 FDA None FDA-2009-P-0597 Addendum - "Volume III of III - Table of Exhibits 51-94" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:04Z   0 0 0900006480a6ccd0
FDA-2009-P-0597-0025 FDA None FDA-2009-P-0597 Tab 61/Exhibit 61 - "The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays: History, Recommendations and Local Delivery Issues, Presented at OINDP Subcommittee of Advisory Committee for Pharmaceutical Science, July 2001 " - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:11Z   0 0 0900006480a6cd2f
FDA-2009-P-0597-0001 FDA None FDA-2009-P-0597 GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition Other CP-Citizen Petition 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z   2019-01-30T20:17:16Z   0 0 0900006480a6c85b
FDA-2009-P-0597-0002 FDA None FDA-2009-P-0597 Addendum - "Volume I of III - Table of Exhibits 1-20" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:40Z   0 0 0900006480a6c92f
FDA-2009-P-0597-0013 FDA None FDA-2009-P-0597 Tab 26/Exhibit 26 - "Approved Labeling, Prescribing Information, Flovent Diskus" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:55Z   0 0 0900006480a6caee
FDA-2009-P-0597-0015 FDA None FDA-2009-P-0597 Tab 28/Exhibit 28 - "Approved Labeling, Prescribing Information, Advair Diskus" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material BKG-Background Material 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:57Z   0 0 0900006480a6caf1
FDA-2009-P-0597-0018 FDA None FDA-2009-P-0597 Tab 31/Exhibit 31 - "FDA/CDER Response to Warner Chilcott, May 1, 2009, re Docket ID FDA-2008-P-0586" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:01Z   0 0 0900006480a6cb3a
FDA-2009-P-0597-0023 FDA None FDA-2009-P-0597 Tab 56/Exhibit 56 - "FDA/CDER Response to Ropes & Gray (AstraZeneca,LP), November, 18, 2008, re Docket ID FDA-2006-P-0073" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:43:08Z   0 0 0900006480a6cd2a
FDA-2009-P-0597-0012 FDA None FDA-2009-P-0597 Tab 25/Exhibit 25 - "Approved Labeling, Prescribing Information, Servent Diskus" - [GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-29T05:00:00Z 2009 12     2009-12-30T00:42:53Z   0 0 0900006480a6caed

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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;
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