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5,314 rows where agency_id = "FDA" and posted_year = 2009 sorted by posted_date descending

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document_type 5

posted_year 1

  • 2009 · 5,314 ✖

agency_id 1

  • FDA · 5,314 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0272-0003 FDA FDA-2009-P-0272 FDA/CDER Response to Sanofi-aventis, U.S., LLC - Petition Partial Approval and Denial Other PPAD-Petition Partial Approval and Denial 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2013-07-27T23:02:09Z   0 0 0900006480a68fe7
FDA-1995-S-0036-0109 FDA Public Disclosure Materials for Emergency Research Studies Conducted Under 21 CFR 50.24 FDA-1995-S-0036 Report 38 - Baylor College of Medicine Public Disclosure on IND 100,681 Other RPT-Report 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2013-07-27T23:02:32Z   0 0 0900006480a6b5ec
FDA-2009-P-0598-0001 FDA FDA-2009-P-0598 James Matthew Weber - Citizen Petition Other CP-Citizen Petition 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2012-03-06T19:35:08Z   0 0 0900006480a74a4d
FDA-2004-D-0123-0004 FDA Current Good Manufacturing Practices for Combination Products FDA-2004-D-0123 See FDA-2004-D-0123-0006 Supporting & Related Material Background Material 2009-12-31T05:00:00Z 2009 12     2015-01-21T02:54:57Z   0 0 0900006480a74ac3
FDA-2009-P-0298-0007 FDA FDA-2009-P-0298 FDA/CFSAN Interim Response to OVOS Natural Health, Inc. (Ullman, Shapiro & Ullman, LLP) - Letter Other LET-Letter 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2013-08-11T04:36:59Z   0 0 0900006480a69fe6
FDA-2009-P-0598-0002 FDA FDA-2009-P-0598 Acknowledgement Letter to James Matthew Weber Other ACK-Acknowledgement Letter 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2013-08-11T01:31:47Z   0 0 0900006480a74a4e
FDA-2008-D-0525-0013 FDA FDA-2008-D-0525 New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products: Guidance for Industry Other Guidance 2009-12-31T05:00:00Z 2009 12 2009-12-31T05:00:00Z   2024-11-07T22:12:12Z   1 0 0900006480a77652
FDA-2009-N-0592-0004 FDA FDA-2009-N-0592 Reference 3 - ‘‘National Research Act, Title II (Public Law 93–348, July 12, 1974)" - [Informed Consent Elements] Supporting & Related Material BKG-Background Material 2009-12-30T05:00:00Z 2009 12     2010-03-04T04:00:30Z   0 0 0900006480a733d4
FDA-2008-N-0546-0009 FDA FDA-2008-N-0546 Agency Information Collection Activities; Proposed Collection; Comment Request; Pet Food Early Warning Recall Rational Questionnaire as Part of the MedWatchPlus Notice N-Notice 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z 2010-01-30T04:59:59Z 2009-12-30T17:57:40Z E9-30872 0 0 0900006480a741c2
FDA-2009-N-0664-0131 FDA FDA-2009-N-0664 Medical Device Interoperability; Public Workshop Notice NM-Notice of Meeting 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z   2009-12-30T17:44:57Z E9-30871 0 0 0900006480a740cd
FDA-2009-N-0592-0002 FDA FDA-2009-N-0592 Reference 1 - ‘‘Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, Vol. 2, pp. 181–182. Office, 1949" - [Informed Consent Elements] Supporting & Related Material BKG-Background Material 2009-12-30T05:00:00Z 2009 12     2010-03-04T03:57:45Z   0 0 0900006480a7336d
FDA-2009-N-0664-0130 FDA FDA-2009-N-0664 Advisory Committees; Tentative Schedule of Meetings for 2010 Notice N-Notice 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z   2009-12-30T17:39:27Z E9-30973 0 0 0900006480a74087
FDA-2009-N-0592-0003 FDA FDA-2009-N-0592 Reference 2 - "World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects" - [Informed Consent Elements] Supporting & Related Material BKG-Background Material 2009-12-30T05:00:00Z 2009 12     2010-03-04T03:59:28Z   0 0 0900006480a733cd
FDA-2009-N-0592-0005 FDA FDA-2009-N-0592 Reference 4 - ‘‘National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, ‘‘The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research’’ - [Informed Consent Elements] Supporting & Related Material BKG-Background Material 2009-12-30T05:00:00Z 2009 12     2010-03-04T04:01:40Z   0 0 0900006480a7340b
FDA-2009-N-0664-0132 FDA FDA-2009-N-0664 Second Annual Sentinel Initiative Public Workshop Notice NM-Notice of Meeting 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z   2009-12-30T17:49:10Z E9-30971 0 0 0900006480a740d2
FDA-2009-P-0282-0003 FDA FDA-2009-P-0282 FDA/CDRH to Mr. David S. Smith (Pepper Hamilton, LLP) Other LET-Letter 2009-12-30T05:00:00Z 2009 12 2009-12-30T05:00:00Z   2013-07-27T23:03:28Z   0 0 0900006480a7444f
FDA-2009-D-0461-0015 FDA FDA-2009-D-0461 See FDA-2009-D-0461-0026 Supporting & Related Material   2009-12-30T00:00:00Z 2009 12     2013-07-29T17:10:22Z   0 1 0900006480a70e27
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-N-0592-0001 FDA FDA-2009-N-0592 Informed Consent Elements Proposed Rule NPR-Notice of Proposed Rule-Making 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z 2010-03-02T04:59:59Z 2011-06-11T16:28:10Z E9-30751 0 0 0900006480a7316e
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-N-0393-0012 FDA FDA-2009-N-0393 Reference 6 - "U.S. Food and Drug Administration, Acrylamide in Food" - [Acrylamide in Food; Request for Comments and for Scientific Data and Information] Supporting & Related Material BKG- Background Material (internal references) 2009-12-29T05:00:00Z 2009 12     2009-12-29T19:57:39Z   0 0 0900006480a11c83
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-D-0591-0001 FDA FDA-2009-D-0591 Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions;Availability Notice NAD-Notice of Availability of Data 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z   2009-12-29T14:32:34Z E9-30750 0 0 0900006480a7313d
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-D-0591-0002 FDA FDA-2009-D-0591 Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions Other GDL-Guidance (Supporting and Related Materials) 2009-12-29T05:00:00Z 2009 12 2009-12-29T05:00:00Z   2024-11-07T22:11:11Z   1 0 0900006480a73756
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
FDA-1996-P-0383-0001 FDA ANDA Suitability for Nuprin in a Spoon Dose Sachets-CLOSED FDA-1996-P-0383 Fuisz Technologies Ltd - Citizen Petition Other CP-Citizen Petition 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2009-12-28T20:30:15Z   0 0 0900006480506ffd
FDA-1996-P-0383-0002 FDA ANDA Suitability for Nuprin in a Spoon Dose Sachets-CLOSED FDA-1996-P-0383 Fuisz Technologies Ltd - Letter Other LET-Letter 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2009-12-28T20:30:17Z   0 0 0900006480507008
FDA-2009-D-0600-0001 FDA FDA-2009-D-0600 Draft Guidance for Industry on Tobacco Health Document Submission; Availability Notice Notice of Availability 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z 2010-01-23T04:59:59Z 2016-09-09T14:32:45Z E9-30657 0 0 0900006480a72053
FDA-1984-P-0333-0001 FDA ANDA FOR IBUPROFEN 200 MG CONVENTIONAL CAPSULES-CLOSED FDA-1984-P-0333 Petition Approval from Center for Drugs and Biologics to Sterling Drug Inc Other Approval 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2022-05-17T20:03:37Z   0 0 09000064805a9401
FDA-1996-P-0383-0004 FDA ANDA Suitability for Nuprin in a Spoon Dose Sachets-CLOSED FDA-1996-P-0383 Acknowledgement Letter to Fuisz Technologies LTD Other ACK-Acknowledgement Letter 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2009-12-28T20:30:21Z   0 0 0900006480a72ac2
FDA-1996-P-0383-0003 FDA ANDA Suitability for Nuprin in a Spoon Dose Sachets-CLOSED FDA-1996-P-0383 Fuisz Technologies Ltd. - Withdrawal Other CP-Citizen Petition 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2013-07-27T21:20:27Z   0 0 090000648050700a
FDA-2009-N-0665-0077 FDA FDA-2009-N-0665 New Animal Drugs; Change of Sponsor; Isoflurane Rule Final Rule 2009-12-28T05:00:00Z 2009 12     2013-07-09T18:25:09Z E9-30590 0 0 0900006480a72080
FDA-1984-P-0333-0002 FDA ANDA FOR IBUPROFEN 200 MG CONVENTIONAL CAPSULES-CLOSED FDA-1984-P-0333 Acknowledgement Letter from Dockets Management Branch to Sterling Drug Inc Other Acknowledgement Letter/Receipt 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2022-05-18T15:15:25Z   0 0 0900006480a72b74
FDA-2009-D-0600-0002 FDA FDA-2009-D-0600 Draft Guidance for Industry on Tobacco Health Document Submission - Guidance Other Guidance 2009-12-28T05:00:00Z 2009 12 2009-12-28T05:00:00Z   2024-11-07T22:13:38Z   1 0 0900006480a71ffb
FDA-2009-Q-0301-0014 FDA FDA-2009-Q-0301 Section B - "Summary of Scientific Basis for Petition, (Summary 12.18 Rev.)" - [Nestle Infant Nutrition/Gerber Products Company - Qualified Health Claim Petition] re FDA-2009-Q-0301-0002 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-23T05:00:00Z 2009 12     2009-12-23T06:37:23Z   0 0 0900006480a7006a
FDA-2009-P-0297-0003 FDA FDA-2009-P-0297 AllerQuest LLC to FDA - Withdrawal of Petition Other WDL-Withdrawal 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2013-07-27T23:03:06Z   0 0 0900006480a7087b
FDA-2002-D-0223-0003 FDA Information for the use of Human Blood & Blood Components FDA-2002-D-0223 An Acceptable Circular of Information for the Use of Human Blood and Blood Components - Level 2 Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2024-11-07T22:12:43Z   1 0 0900006480a700ff
FDA-2009-N-0664-0129 FDA FDA-2009-N-0664 Gastrointestinal Drugs Advisory Committee Notice of Meeting Notice NM-Notice of Meeting 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2009-12-23T19:25:45Z E9-30442 0 0 0900006480a704a2
FDA-2009-P-0305-0001 FDA FDA-2009-P-0305 Hygeia II Medical Group Inc. - Citizen Petition Other CP-Citizen Petition 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2020-05-05T14:43:19Z   0 0 09000064809e79c6
FDA-2009-P-0305-0002 FDA FDA-2009-P-0305 Acknowledgement Letter to Hygeia II Medical Group Inc. Other ACK-Acknowledgement Letter 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2009-12-23T15:29:49Z   0 0 09000064809e79c9
FDA-1987-P-0230-0002 FDA IBUPROFEN 200MG SOFT GELATIN CAPSULES ANDA SUITABILILTY-CLOSED FDA-1987-P-0230 FDA/Center for Drugs and Biologics - Petition Approval Other PAV-Petition Approval 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2013-07-27T20:47:57Z   0 0 090000648046d7d3
FDA-2009-P-0305-0003 FDA FDA-2009-P-0305 FDA/Center for Devices and Radiological Health Interim Response to Hygeia II Medical Group Inc. Other LET-Letter 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2013-08-11T01:31:35Z   0 0 0900006480a6b1c4
FDA-1987-P-0230-0003 FDA IBUPROFEN 200MG SOFT GELATIN CAPSULES ANDA SUITABILILTY-CLOSED FDA-1987-P-0230 Acknowledgement Letter to Sidmak Laboratories Inc Other ACK-Acknowledgement Letter 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2009-12-23T17:23:52Z   0 0 0900006480a707a1
FDA-2008-D-0399-0006 FDA FDA-2008-D-0399 International Conference on Harmonisation: Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Annex 5: Disintegration Test General Chapter Notice NAD-Notice of Availability of Data 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2009-12-23T19:06:42Z E9-30441 0 0 0900006480a70631
FDA-2008-D-0399-0007 FDA FDA-2008-D-0399 Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, Annex 5 Disintegration Test General Chapter - Guidance for Industry Other GDL-Guidance (Supporting and Related Materials) 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2024-11-12T04:49:00Z   1 0 0900006480a70857
FDA-1987-P-0230-0001 FDA IBUPROFEN 200MG SOFT GELATIN CAPSULES ANDA SUITABILILTY-CLOSED FDA-1987-P-0230 Sidmak Laboratories, Inc - Citizen Petition Other CP-Citizen Petition 2009-12-23T05:00:00Z 2009 12 2009-12-23T05:00:00Z   2013-07-27T20:47:57Z   0 0 090000648046d7d2
FDA-1975-N-0012-0025 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab E - "Alcavis International, Inc., Letter to FDA, March 18, 2003" - [Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:35:48Z   0 0 0900006480a4d2b1
FDA-1975-N-0012-0033 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab M - "Alcavis International, Inc. (Alston & Bird, LLP) Letter to FDA, October 4, 2006" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:57:54Z   0 0 0900006480a4d4e9
FDA-1975-N-0012-0029 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab I - "Alcavis International, Inc. Letter to FDA, July 1, 2003" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:51:54Z   0 0 0900006480a4d497
FDA-1975-N-0012-0028 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab H - "Alcavis International, Inc. Letter to FDA, June 17, 2003" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:50:56Z   0 0 0900006480a4d459
FDA-1975-N-0012-0027 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab G - "Alcavis International, Inc. Letter to FDA, June 5, 2003" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:50:16Z   0 0 0900006480a4d355
FDA-1975-N-0012-0024 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab D - "Alcavis International, Inc., Letter to FDA, December 20, 2002" - [Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:34:25Z   0 0 0900006480a4d2af
FDA-1975-N-0012-0036 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Index of Select Scientific References Cited - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0018 Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-10-27T17:29:30Z   0 0 0900006480a6f8fa
FDA-1975-N-0012-0034 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab N - "Alcavis International, Inc. (Alston & Bird, LLP) Supplement, February 6, 2009" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T21:00:16Z   0 0 0900006480a4d7b5
FDA-2009-D-0588-0002 FDA FDA-2009-D-0588 Guidance for Industry on the Timeframe for Submission of Tobacco Health Documents - Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-12-22T05:00:00Z 2009 12 2009-12-22T05:00:00Z   2024-11-07T22:11:18Z   1 0 0900006480a6f5bc
FDA-2009-D-0013-0005 FDA FDA-2009-D-0013 International Conference on Harmonisation: Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions - Guidance Other GDL-Guidance (Supporting and Related Materials) 2009-12-22T05:00:00Z 2009 12     2024-11-07T22:13:57Z   1 0 0900006480a6f8f1
FDA-1975-N-0012-0021 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab A - Citizen Petition Filed by Robert G. Pinco, Akin, Gump, Strauss, Hauer & Feld, January 29, 1999 - (Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:31:45Z   0 0 0900006480a4d24e
FDA-1975-N-0012-0023 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab C - "FDA Response to Alcavis International, Inc., November 14, 2002" - [Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:33:42Z   0 0 0900006480a4d2ac
FDA-1975-N-0012-0035 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab O - "FDA/CDER Response to Alcavis International, Inc. - Petition Denial, April 24, 2009" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T21:01:01Z   0 0 0900006480a4d7b6
FDA-1975-N-0012-0022 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab B - "Citizen Petition Filed by Alcavis, International, Inc., Feburary 20, 2002" - [Alcavis, International, Inc., (Buchanan Ingerson and Rooney PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:32:56Z   0 0 0900006480a4d252
FDA-1975-N-0012-0026 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab F - "68 Federal Register 32003 Dated May 29, 2003" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:38:00Z   0 0 0900006480a4d350
FDA-2009-D-0013-0004 FDA FDA-2009-D-0013 International Conference on Harmonisation: Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions Notice NAD-Notice of Availability of Data 2009-12-22T05:00:00Z 2009 12 2009-12-22T05:00:00Z   2009-12-22T16:28:44Z E9-30326 0 0 0900006480a6f728
FDA-1975-N-0012-0031 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab K - "Alcavis International, Inc. Letter to FDA, March 15, 2004" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:55:21Z   0 0 0900006480a4d4e6
FDA-2009-N-0665-0075 FDA FDA-2009-N-0665 Freedom of Information Summary Supplemental New Aminal Drug Application - [NADA 141-172] Supporting & Related Material Freedom of Information Summary 2009-12-22T05:00:00Z 2009 12     2013-07-09T16:17:26Z   0 0 0900006480a6f354
FDA-1975-N-0012-0030 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab J - "Alcavis International, Inc. Letter to FDA, February 10, 2004" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:52:26Z   0 0 0900006480a4d4e4
FDA-1975-N-0012-0032 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Tab L - "Alcavis International, Inc. (Alston & Bird, LLP) Letter to FDA, July 15, 2005" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Supporting & Related Material Background Material 2009-12-22T05:00:00Z 2009 12     2017-11-29T20:56:35Z   0 0 0900006480a4d4e7
FDA-2009-D-0588-0001 FDA FDA-2009-D-0588 Guidance for Industry on the Timeframe for Submission of Tobacco Health Documents; Availability Notice NAD-Notice of Availability of Data 2009-12-21T05:00:00Z 2009 12 2009-12-21T05:00:00Z   2009-12-22T15:59:22Z E9-30297 0 0 0900006480a6ef9e
FDA-2009-N-0665-0076 FDA FDA-2009-N-0665 Implantation or Injectable Dosage Form New Animal Drugs: Polysulfated Glycosaminoglycan Rule Final Rule 2009-12-21T05:00:00Z 2009 12     2013-07-09T15:52:49Z E9-30222 0 0 0900006480a6eff2
FDA-2003-M-0501-0001 FDA Express & Express2 Monorail & Over-the-Wire Coronary Stent FDA-2003-M-0501 Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications Notice N-Notice 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z   2025-04-16T19:38:47Z 03-27119 0 0 09000064804a2b25
FDA-2009-P-0405-0021 FDA FDA-2009-P-0405 Consumers Union and Food Animal Concerns Trust (FACT) [Multiple Names=37,170 Citizens] - Letter Other LET-Letter 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z   2010-01-05T22:42:57Z   0 0 0900006480a6e1f4
FDA-2003-M-0501-0003 FDA Express & Express2 Monorail & Over-the-Wire Coronary Stent FDA-2003-M-0501 DUPLICATE Other AAV-Approval of Application 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z   2025-04-01T19:30:11Z   0 0 09000064804a2b21
FDA-2009-P-0405-0022 FDA FDA-2009-P-0405 Enclosure 1 - "Stop Feeding Chicken Feces to Cows!" - [Consumers Union and Food Animal Concerns Trust (FACT) (Multiple Signatures=13,540) - Comment] re FDA-2009-P-0405-0021 Supporting & Related Material LET-Letter (Supporting and Related Material) 2009-12-18T05:00:00Z 2009 12     2010-01-05T22:48:59Z   0 0 0900006480a6e2fa
FDA-2003-M-0501-0002 FDA Express & Express2 Monorail & Over-the-Wire Coronary Stent FDA-2003-M-0501 Premarket Approval Response Letter from FDA CDRH to Boston Scientific Scimed, Inc. Other Approval 2009-12-18T05:00:00Z 2009 12 2009-12-18T05:00:00Z   2025-04-01T19:34:05Z   0 0 09000064804a2b1f

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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);