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withdrawn,object_id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-1977-N-0013-0048,FDA,FDA-1977-N-0013,Citizen Petition from GlaxoSmithKline Consumer Healthcare (GSKCH),Other,Citizen Petition,2017-07-17T04:00:00Z,2017,7,2017-07-17T04:00:00Z,,2024-11-12T05:15:25Z,,1,0,09000064813341f7
FDA-1977-N-0013-0047,FDA,FDA-1977-N-0013,McNeil Consumer Healthcare - Letter,Other,Letter(s),2012-01-26T05:00:00Z,2012,1,2012-01-26T05:00:00Z,,2012-01-26T15:07:32Z,,0,0,0900006480fa55cd
FDA-1977-N-0013-0046,FDA,FDA-1977-N-0013,Interim Response to GlaxoSmithKline Consumer Healthcare - Letter,Other,Letter(s),2011-07-21T04:00:00Z,2011,7,2011-07-21T04:00:00Z,,2011-07-21T12:31:43Z,,0,0,0900006480ec80bf
FDA-1977-N-0013-0042,FDA,FDA-1977-N-0013,Citizen Petition from GlaxoSmithKline Consumer Healthcare,Other,Citizen Petition,2011-03-24T04:00:00Z,2011,3,2011-03-24T04:00:00Z,,2019-02-05T12:47:52Z,,0,0,0900006480c0c71c
FDA-1977-N-0013-0044,FDA,FDA-1977-N-0013,"Attachment 2 - Synopsis Report, Study Number A4000685 re: Citizen Petition from GlaxoSmithKline Consumer Healthcare",Supporting & Related Material,Background Material,2011-03-24T04:00:00Z,2011,3,,,2019-02-06T16:43:39Z,,0,0,0900006480c0c908
FDA-1977-N-0013-0045,FDA,FDA-1977-N-0013,Acknowledgment Letter from FDA DDM to GlaxoSmithKline Consumer Healthcare,Other,Acknowledgement Letter/Receipt,2011-03-24T04:00:00Z,2011,3,2011-03-24T04:00:00Z,,2019-02-05T13:13:02Z,,0,0,0900006480c0c93a
FDA-1977-N-0013-0043,FDA,FDA-1977-N-0013,"Attachment 1 - Synopsis Report, Study Number A4000684 re: Citizen Petition from GlaxoSmithKline Consumer Healthcare",Supporting & Related Material,Background Material,2011-03-24T04:00:00Z,2011,3,,,2019-02-05T13:00:37Z,,0,0,0900006480c0c905
FDA-1977-N-0013-0041,FDA,FDA-1977-N-0013,"Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment",Rule,Final Rule,2009-11-25T05:00:00Z,2009,11,2009-11-25T05:00:00Z,,2019-02-22T12:55:02Z,E9-28296,0,0,0900006480a5e8d7
FDA-1977-N-0013-0039,FDA,FDA-1977-N-0013,"Letter from CHPA to Michael S. Furness of Nonprescription Regulation Development, ONP, CDER/FDA",Other,Letter(s),2009-08-27T04:00:00Z,2009,8,2009-08-27T04:00:00Z,,2019-02-22T13:00:14Z,,0,0,0900006480a1487c
FDA-1977-N-0013-0040,FDA,FDA-1977-N-0013,"Letter from CHPA to Ms. Arlene Solbeck, CDER/FDA",Other,Letter(s),2009-08-27T04:00:00Z,2009,8,2009-08-27T04:00:00Z,,2019-02-22T13:01:02Z,,0,0,0900006480a14f53
FDA-1977-N-0013-0037,FDA,FDA-1977-N-0013,"Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Corrections",Rule,Correction,2009-06-30T04:00:00Z,2009,6,2009-06-30T04:00:00Z,,2019-02-21T21:46:48Z,E9-15403,0,0,09000064809e636f
FDA-1977-N-0013-0038,FDA,FDA-1977-N-0013,"List of References re: Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Corrections",Other,List (LST),2009-06-30T04:00:00Z,2009,6,2009-06-30T04:00:00Z,,2019-02-21T21:50:59Z,,0,0,09000064809e699e
FDA-1977-N-0013-0021,FDA,FDA-1977-N-0013,Reference 3 - Comment No. EMC1 re: Background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-06T12:47:24Z,,0,0,0900006480828e3e
FDA-1977-N-0013-0018,FDA,FDA-1977-N-0013,"Public Administrative File - Organ-Specific Warnings: Internal Analgesic Antipyretic, and Antihreumatic Drug Products for Over-the Counter Human Use; Final Monograph - Memorandum",Supporting & Related Material,BKG-Background Material,2009-04-29T04:00:00Z,2009,4,,,2009-04-29T20:19:30Z,,0,0,09000064808215d4
FDA-1977-N-0013-0019,FDA,FDA-1977-N-0013,Reference 1 - Comment No. C7. re: Background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-06T12:41:34Z,,0,0,0900006480828df1
FDA-1977-N-0013-0026,FDA,FDA-1977-N-0013,Reference 8 - Comment No. EC2 re: Background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T16:16:09Z,,0,0,0900006480828f68
FDA-1977-N-0013-0033,FDA,FDA-1977-N-0013,"Reference 22 - Green, J. L. et al., ""Hepatic Function in Alcoholic Throughout 5 Days of Maximal Therapeutic Dosing of Acetaminophen (APAP),"" Clinical Toxicology. 43:683, 2005. re: Background Material from FDA",Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T16:48:10Z,,0,0,0900006480829070
FDA-1977-N-0013-0030,FDA,FDA-1977-N-0013,Reference 12 - Comment No. C8 re: Background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T16:34:51Z,,0,0,0900006480828faa
FDA-1977-N-0013-0027,FDA,FDA-1977-N-0013,Reference 9 - Comment No. EREG1 re: background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-06T12:56:30Z,,0,0,0900006480828f78
FDA-1977-N-0013-0031,FDA,FDA-1977-N-0013,"Reference 56 - Eastern Research Group, Inc. ""Cost Benefit Analysis of Proposed FDA Rule on Over-the-Counter Internal Analgesic, Antipyretic, and Antirheumatic Drug Products; Required Warnings,"" Final Report, October 6, 2004, with Addendum, July 30, 2007. re: Background Material from FDA",Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-06T13:53:22Z,,0,0,0900006480829222
FDA-1977-N-0013-0034,FDA,FDA-1977-N-0013,"Reference 23 -Dargere, S. et al., ""Lack of Toxicity of Acetaminophen in Patients with Chronic Hepatitis C: A Randomized Controlled Trial,"" Gastroenterology. 118:A947, 2000 re: Background Material from FDA",Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-06T13:05:17Z,,0,0,090000648082907d
FDA-1977-N-0013-0022,FDA,FDA-1977-N-0013,Reference 4 - Comment No. EREG4 re: Background Material,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T15:41:42Z,,0,0,0900006480828e48
FDA-1977-N-0013-0020,FDA,FDA-1977-N-0013,Reference 2 - Comment No. C3. re: Background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T15:21:45Z,,0,0,0900006480828e2b
FDA-1977-N-0013-0028,FDA,FDA-1977-N-0013,Reference 10 - Comment No. C5 re: Background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T16:24:22Z,,0,0,0900006480828f8b
FDA-1977-N-0013-0035,FDA,FDA-1977-N-0013,"Reference 24 - ""Action Plan for Liver Disease Research. A Report of the Liver Disease Subcommittee of the Digestive Diseases Interagency Coordinating Committee,"" NIH Publication No. 04-5491, 2004. re: Background Material from FDA",Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-06T13:08:26Z,,0,0,0900006480829082
FDA-1977-N-0013-0025,FDA,FDA-1977-N-0013,Reference 7 - Comment No. EC1 re : Background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T16:14:04Z,,0,0,0900006480828eff
FDA-1977-N-0013-0029,FDA,FDA-1977-N-0013,Reference 11 - Comment No. EC4 re: Background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T16:33:06Z,,0,0,0900006480828f97
FDA-1977-N-0013-0017,FDA,FDA-1977-N-0013,"Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph",Rule,Final Rule,2009-04-29T04:00:00Z,2009,4,2009-04-29T04:00:00Z,,2019-03-20T19:57:29Z,E9-9684,0,0,090000648096ef53
FDA-1977-N-0013-0023,FDA,FDA-1977-N-0013,Reference 5 - Comment No. C6 re: Background Material from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T16:04:41Z,,0,0,0900006480828e54
FDA-1977-N-0013-0036,FDA,FDA-1977-N-0013,Reference 49 - Comment No. C1 re: Background Material  from FDA,Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-05T17:45:03Z,,0,0,09000064808291cf
FDA-1977-N-0013-0032,FDA,FDA-1977-N-0013,"Reference 56 - Eastern Research Group, Inc. ""Cost Benefit Analysis of Proposed FDA Rule on Overthe-Counter Internal Analgesic, Antipyretic, and Antirheumatic Drug Products; Required Warnings,"" Final Report, October 6, 2004, with Addendum, July 30, 2007. re: Background Material from FDA (Part 2 of Reference 56)",Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-06T14:05:23Z,,0,0,0900006480829234
FDA-1977-N-0013-0024,FDA,FDA-1977-N-0013,"Reference 6 - Letter from Charles Ganley, FDA, to NSAID NDA Holders, July 2005 re: Background Material from FDA",Supporting & Related Material,Background Material,2009-04-29T04:00:00Z,2009,4,,,2019-02-06T12:51:03Z,,0,0,0900006480828ea3
FDA-1977-N-0013-0011,FDA,FDA-1977-N-0013,Submission Table of Contents re: Comment from McNeil Consumer Healthcare,Supporting & Related Material,Background Material,2008-11-07T05:00:00Z,2008,11,,,2019-03-20T14:08:38Z,,0,0,09000064805d80b1
FDA-1977-N-0013-0010,FDA,FDA-1977-N-0013,Background Material - BKG1 - References,Supporting & Related Material,BKG-Background Material,2008-11-07T05:00:00Z,2008,11,,,2008-11-07T20:29:50Z,,0,0,09000064805d7f4a
FDA-1977-N-0013-0001,FDA,FDA-1977-N-0013,"Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2006-12-19T05:00:00Z,2006,12,2006-12-19T05:00:00Z,2007-06-20T03:59:59Z,2019-03-23T23:59:29Z,E6-21855,0,0,09000064805d7f3f