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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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