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withdrawn,object_id FDA-1978-N-0021-0042,FDA,FDA-1978-N-0021,FDA/CDER Maalox Total Relief Memo Meeting minutes and Quarterly Reports 12 9 11,Other,Report,2011-12-27T05:00:00Z,2011,12,2011-12-27T05:00:00Z,,2011-12-27T13:50:45Z,,0,0,0900006480f899cc FDA-1978-N-0021-0040,FDA,FDA-1978-N-0021,"Letter from C.B. Fleet Company, Inc.",Other,Letter(s),2011-02-14T05:00:00Z,2011,2,2011-02-14T05:00:00Z,,2016-09-13T15:20:59Z,,0,0,0900006480bc8d4a FDA-1978-N-0021-0038,FDA,FDA-1978-N-0021,XI. List of References 1 - 43 - [1978-N-0021 formerly Docket 1978N-0036L],Supporting & Related Material,Background Material,2011-02-11T05:00:00Z,2011,2,,,2016-09-26T14:11:16Z,,0,0,0900006480bebd6c FDA-1978-N-0021-0039,FDA,FDA-1978-N-0021,Reference 1 - FDA-2007-P-0345.0031 - [ XI. References 1 - 43 - FDA-1978-N-0021 (formerly Docket 1978N-0036L) - List],Supporting & Related Material,Background Material,2011-02-11T05:00:00Z,2011,2,,,2016-09-26T14:11:29Z,,0,0,0900006480bebdd0 FDA-1978-N-0021-0037,FDA,FDA-1978-N-0021,Notice of Proposed Rulemaking re Professional Labeling for Laxative Drug Products for Over-the-Counter Human Use: Amendment to Tentative Final Monograph,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-02-11T05:00:00Z,2011,2,2011-02-11T05:00:00Z,2011-03-15T03:59:59Z,2016-08-22T20:55:33Z,2011-3091,0,0,0900006480becd42 FDA-1978-N-0021-0034,FDA,FDA-1978-N-0021,Attachment 2 - FDA Alert (12/11/2008) [FDA-1978-N-0021-0032],Supporting & Related Material,LET-Letter (Supporting and Related Material),2010-12-29T05:00:00Z,2010,12,,,2010-12-29T19:21:54Z,,0,0,0900006480bc2184 FDA-1978-N-0021-0035,FDA,FDA-1978-N-0021,Attachment 3 - FDA Alert (5/2006) [FDA-1978-N-0021-0032],Supporting & Related Material,BKG-Background Material,2010-12-29T05:00:00Z,2010,12,,,2010-12-29T19:30:50Z,,0,0,0900006480bc2187 FDA-1978-N-0021-0033,FDA,FDA-1978-N-0021,"Attachment 1 - Letter to Peter S. Reichertz, Esq [FDA-1978-N-0021-0032]",Supporting & Related Material,LET-Letter (Supporting and Related Material),2010-12-29T05:00:00Z,2010,12,,,2010-12-29T19:16:08Z,,0,0,0900006480bc2182 FDA-1978-N-0021-0032,FDA,FDA-1978-N-0021,"Letter from FDA/CDER to Peter S. Reichertz, Esq. and Christopher A. Brown, Esq.",Other,LET-Letter,2010-12-29T05:00:00Z,2010,12,2010-12-29T05:00:00Z,,2016-09-13T15:18:53Z,,0,0,0900006480bc2181 FDA-1978-N-0021-0036,FDA,FDA-1978-N-0021,Attachment 4 - Science Backgrounder: Safethy of Sodium Phosphates Oral Solution [FDA-1978-N-0021-0032],Supporting & Related Material,LET-Letter (Supporting and Related Material),2010-12-29T05:00:00Z,2010,12,,,2010-12-29T19:35:46Z,,0,0,0900006480bc226a FDA-1978-N-0021-0029,FDA,FDA-1978-N-0021,"C. B. Fleet Company, Inc. - Supplement to Citizen Petition of March 23, 1993",Other,Supplement (SUP),2008-12-11T05:00:00Z,2008,12,2008-12-11T05:00:00Z,,2016-09-15T19:25:51Z,,0,0,090000648055d1e8 FDA-1978-N-0021-0031,FDA,FDA-1978-N-0021,"FDA to Peter S. Reichertz, Esq. and Christopher A. Brown, Esq. - Petition Denied",Other,PDN-Petition Denial,2008-12-11T05:00:00Z,2008,12,2008-12-11T05:00:00Z,,2008-12-22T18:06:25Z,,0,0,09000064807d803a FDA-1978-N-0021-0030,FDA,FDA-1978-N-0021,Citizen Petition from C.B. Fleet Company,Other,Citizen Petition,2008-12-11T05:00:00Z,2008,12,2008-12-11T05:00:00Z,,2016-09-22T17:33:54Z,,0,0,090000648055d60d FDA-1978-N-0021-0028,FDA,FDA-1978-N-0021,Transmittal sheet re letter from FDA/CDER to The Purdue Frederick Company,Supporting & Related Material,Transmittals,2006-10-04T04:00:00Z,2006,10,,,2016-08-16T18:04:51Z,,0,0,090000648055d752 FDA-1978-N-0021-0027,FDA,FDA-1978-N-0021,Letter from FDA/CDER to The Purdue Frederick Company,Other,Letter(s),2006-10-04T04:00:00Z,2006,10,,,2016-08-16T18:02:23Z,,0,0,090000648055d750 FDA-1978-N-0021-0024,FDA,FDA-1978-N-0021,Petition approval from FDA/Office of the Commissioner to The Purdue Frederick Company,Other,Approval,2005-01-07T05:00:00Z,2005,1,,,2016-09-21T15:20:42Z,,0,0,090000648055d73d FDA-1978-N-0021-0023,FDA,FDA-1978-N-0021,"Petition approval from FDA/Office of the Commissioner to Sonnenschein, Nath & Rosenthal, LLP",Other,Approval,2004-10-12T04:00:00Z,2004,10,,,2016-09-21T15:20:31Z,,0,0,090000648055d73c FDA-1978-N-0021-0022,FDA,FDA-1978-N-0021,"Acknowledgement Letter from FDA/DDM to Sonnenschein, Nath & Rosenthal, LLP",Other,Acknowledgement Letter/Receipt,2004-05-20T04:00:00Z,2004,5,,,2016-09-21T15:24:25Z,,0,0,090000648055d73a FDA-1978-N-0021-0021,FDA,FDA-1978-N-0021,"Acknowledgement Letter from FDA/DDM to Sonnenschein, Nath & Rosenthal, LLP",Other,Acknowledgement Letter/Receipt,2004-05-20T04:00:00Z,2004,5,,,2016-09-21T15:23:39Z,,0,0,090000648055d738 FDA-1978-N-0021-0020,FDA,FDA-1978-N-0021,Acknowledgement Letter from FDA/DDM to The Purdue Frederick Company,Other,Acknowledgement Letter/Receipt,2004-04-13T04:00:00Z,2004,4,,,2016-09-21T15:48:55Z,,0,0,090000648055d729 FDA-1978-N-0021-0019,FDA,FDA-1978-N-0021,Acknowledgement Letter from FDA/DDM to The Purdue Frederick Company,Other,Acknowledgement Letter/Receipt,2004-04-13T04:00:00Z,2004,4,,,2016-08-10T20:19:03Z,,0,0,090000648055d728 FDA-1978-N-0021-0018,FDA,FDA-1978-N-0021,"Letter from FDA/CDER to Sonnenschein, Nath & Rosenthal",Other,Letter(s),2004-01-06T05:00:00Z,2004,1,,,2016-09-19T20:40:02Z,,0,0,090000648055d6a5 FDA-1978-N-0021-0017,FDA,FDA-1978-N-0021,Acknowledgment letter from FDA/CDER to C.I.B.A. Consumer Pharmaceuticals,Other,Acknowledgement Letter/Receipt,2003-12-10T05:00:00Z,2003,12,,,2016-09-16T13:25:45Z,,0,0,090000648055d699 FDA-1978-N-0021-0015,FDA,FDA-1978-N-0021,"Petition Denial from FDA/Office of the Commissioner to Banner Pharmacaps, Inc.",Other,Denial of Petition,2003-11-19T05:00:00Z,2003,11,,,2016-08-09T18:36:38Z,,0,0,090000648055d687 FDA-1978-N-0021-0016,FDA,FDA-1978-N-0021,"Petition Denial from FDA/Office of the Commissioner to Banner Pharmacaps, Inc.",Other,Denial of Petition,2003-11-19T05:00:00Z,2003,11,,,2016-09-19T20:46:15Z,,0,0,090000648055d696 FDA-1978-N-0021-0014,FDA,FDA-1978-N-0021,Notice of Proposed Rulemaking re Laxative Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2003-10-23T04:00:00Z,2003,10,2003-10-22T04:00:00Z,2004-01-21T04:59:59Z,2016-08-09T20:43:30Z,,0,0,090000648055d669 FDA-1978-N-0021-0013,FDA,FDA-1978-N-0021,Letter from FDA/CDER to The Purdue Frederick Company,Other,Letter(s),2003-10-22T04:00:00Z,2003,10,,,2016-09-21T15:00:19Z,,0,0,090000648055d666 FDA-1978-N-0021-0012,FDA,FDA-1978-N-0021,Petition Denial from FDA/Office of the Commissioner to The Purdue Frederick Company,Other,Denial of Petition,2003-09-17T04:00:00Z,2003,9,,,2016-09-21T15:00:53Z,,0,0,090000648055d662 FDA-1978-N-0021-0010,FDA,FDA-1978-N-0021,"Petition Denial from FDA/Office of the Commissioner to Arnall Golden Gregory, LLP",Other,Denial of Petition,2003-09-10T04:00:00Z,2003,9,,,2016-09-21T15:01:29Z,,0,0,090000648055d648 FDA-1978-N-0021-0011,FDA,FDA-1978-N-0021,Letter from FDA/CDER,Other,Letter(s),2003-09-10T04:00:00Z,2003,9,,,2016-09-21T15:51:39Z,,0,0,090000648055d64b FDA-1978-N-0021-0009,FDA,FDA-1978-N-0021,Petition Denial from FDA/Office of the Commissioner to American Herbal Products Association-International Aloe Science Council,Other,Denial of Petition,2003-07-25T04:00:00Z,2003,7,,,2016-09-21T15:56:34Z,,0,0,090000648055d631 FDA-1978-N-0021-0008,FDA,FDA-1978-N-0021,Final Rule; Status of Certain Additional Over-the-Counter Drug Category II and Ill Active Ingredients,Rule,Final Rule,2002-05-10T04:00:00Z,2002,5,,,2016-08-03T20:09:29Z,,0,0,090000648055d5e4 FDA-1978-N-0021-0007,FDA,FDA-1978-N-0021,Notice of Proposed Rulemaking- Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph,Proposed Rule,Notice of Proposed Rulemaking (NPRM),1998-06-23T04:00:00Z,1998,6,1998-06-23T04:00:00Z,1998-09-18T03:59:59Z,2016-09-22T14:17:32Z,,0,0,090000648055d3ce FDA-1978-N-0021-0004,FDA,FDA-1978-N-0021,Tab B: Supporting & related materials,Supporting & Related Material,Background Material,1994-04-07T04:00:00Z,1994,4,,,2016-09-16T16:55:56Z,,0,0,090000648055d115 FDA-1978-N-0021-0006,FDA,FDA-1978-N-0021,Tab A: Products complaints and published materials,Supporting & Related Material,Background Material,1994-04-07T04:00:00Z,1994,4,,,2016-09-16T16:55:21Z,,0,0,090000648055d11d FDA-1978-N-0021-0005,FDA,FDA-1978-N-0021,Notice of Proposed Rulemaking -Laxative Drug Products For Over-The-Counter Human Use; Proposed Amendment To The Tentative Final Monograph,Proposed Rule,Notice of Proposed Rulemaking (NPRM),1994-04-07T04:00:00Z,1994,4,1994-04-07T04:00:00Z,1994-06-01T03:59:59Z,2016-08-03T19:58:19Z,,0,0,090000648055d119