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34 rows where docket_id = "FDA-2009-P-0597" sorted by posted_date descending
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document_type 2
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- 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;