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withdrawn,object_id FDA-1975-N-0017-0085,FDA,FDA-1975-N-0017,"Supplement from J. B. Williams Company, Inc.",Other,Supplement (SUP),2011-03-17T04:00:00Z,2011,3,2011-03-17T04:00:00Z,,2017-12-29T15:49:49Z,,0,0,09000064805c2379 FDA-1975-N-0017-0083,FDA,FDA-1975-N-0017,"Letter from FDA/Bureau of Drugs to The J. B. Williams Company, Inc.",Other,Letter(s),2011-02-28T05:00:00Z,2011,2,2011-02-28T05:00:00Z,,2018-01-26T19:16:39Z,,0,0,09000064805c23af FDA-1975-N-0017-0077,FDA,FDA-1975-N-0017,"Objection from Block Drug Company, Inc.",Other,Objection(s),2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2018-01-02T18:04:01Z,,0,0,09000064805c22f4 FDA-1975-N-0017-0079,FDA,FDA-1975-N-0017,Objection from Eli Lilly & Company,Other,Objection(s),2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2018-01-02T17:52:35Z,,0,0,09000064805c22fa FDA-1975-N-0017-0074,FDA,FDA-1975-N-0017,Objection from Center for Science In The Public Interest,Other,Objection(s),2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2018-01-02T18:11:55Z,,0,0,09000064805c22ee FDA-1975-N-0017-0076,FDA,FDA-1975-N-0017,"Objection from Pepsico, Inc.",Other,Objection(s),2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2018-01-02T18:06:26Z,,0,0,09000064805c22f2 FDA-1975-N-0017-0081,FDA,FDA-1975-N-0017,"Objection from Citizen Action, California Citizen Action Group",Other,Objection(s),2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2018-01-02T17:07:48Z,,0,0,09000064805c22fd FDA-1975-N-0017-0073,FDA,FDA-1975-N-0017,"Objection from Miles Laboratories, Inc.",Other,Objection(s),2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2017-12-29T20:37:14Z,,0,0,09000064805c22ec FDA-1975-N-0017-0080,FDA,FDA-1975-N-0017,"Request for Hearing from The J. B. Williams Company, Inc.",Other,Objection(s),2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2018-01-02T17:12:32Z,,0,0,09000064805c22fb FDA-1975-N-0017-0082,FDA,FDA-1975-N-0017,Objection from Bristol-Myers Products,Other,Objection(s),2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2018-01-02T16:58:39Z,,0,0,09000064805c22ff FDA-1975-N-0017-0078,FDA,FDA-1975-N-0017,Correction from Center for Science in the Public Interest,Other,Correction(s),2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2018-01-02T18:00:52Z,,0,0,09000064805c22f6 FDA-1975-N-0017-0075,FDA,FDA-1975-N-0017,Request for Hearing from Feed Good Vitamin Corporation,Other,Request for Hearing,2011-02-18T05:00:00Z,2011,2,2011-02-18T05:00:00Z,,2018-01-02T18:08:21Z,,0,0,09000064805c22f0 FDA-1975-N-0017-0061,FDA,FDA-1975-N-0017,"Study No. S-2162-B re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis)",Supporting & Related Material,Background Material,2011-02-17T05:00:00Z,2011,2,,,2017-12-19T16:04:09Z,,0,0,09000064805c22d6 FDA-1975-N-0017-0062,FDA,FDA-1975-N-0017,"On The Purported Carcinogenesis of Methapyrilene re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis)",Supporting & Related Material,Background Material,2011-02-17T05:00:00Z,2011,2,,,2018-01-02T14:53:12Z,,0,0,09000064805c22d7 FDA-1975-N-0017-0063,FDA,FDA-1975-N-0017,"Exhibit C- Letter to FDA DDM June 13, 1977 re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis)",Supporting & Related Material,Background Material,2011-02-17T05:00:00Z,2011,2,,,2018-01-02T14:53:48Z,,0,0,09000064805c22da FDA-1975-N-0017-0072,FDA,FDA-1975-N-0017,Objection from Schering-Plough Corporation,Other,Objection(s),2011-02-17T05:00:00Z,2011,2,2011-02-17T05:00:00Z,,2017-12-29T20:41:59Z,,0,0,09000064805c22ea FDA-1975-N-0017-0066,FDA,FDA-1975-N-0017,Objection from Consumer Action,Other,Objection(s),2011-02-17T05:00:00Z,2011,2,2011-02-17T05:00:00Z,,2018-01-02T13:35:35Z,,0,0,09000064805c22dd FDA-1975-N-0017-0059,FDA,FDA-1975-N-0017,"Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis)",Other,Request for Hearing,2011-02-17T05:00:00Z,2011,2,2011-02-17T05:00:00Z,,2018-01-02T13:41:02Z,,0,0,09000064805c22d4 FDA-1975-N-0017-0065,FDA,FDA-1975-N-0017,Exhibit E - Report on Studies Supporting the Safety and Efficacy of Dipehnhydramine as a Nighttime Sleep-Aid re: Request for Hearing from Bristol Myers Company,Supporting & Related Material,Background Material,2011-02-17T05:00:00Z,2011,2,,,2018-01-29T14:51:17Z,,0,0,09000064805c22dc FDA-1975-N-0017-0070,FDA,FDA-1975-N-0017,"Request for Hearing from Block Drug Company, Inc.",Other,Request for Hearing,2011-02-17T05:00:00Z,2011,2,2011-02-17T05:00:00Z,,2018-01-02T12:55:24Z,,0,0,09000064805c22e6 FDA-1975-N-0017-0069,FDA,FDA-1975-N-0017,"Objection from Blair Laboratories, Inc.",Other,Objection(s),2011-02-17T05:00:00Z,2011,2,2011-02-17T05:00:00Z,,2018-01-02T13:22:38Z,,0,0,09000064805c22e3 FDA-1975-N-0017-0064,FDA,FDA-1975-N-0017,"Exhibit D - Letter from Health and Welfare Canada to Mrs. N.D. Moore (July 18, 1978) re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis)",Supporting & Related Material,Background Material,2011-02-17T05:00:00Z,2011,2,,,2018-01-02T14:53:58Z,,0,0,09000064805c22db FDA-1975-N-0017-0060,FDA,FDA-1975-N-0017,"W-2080 Hypnotic Activity of Diphenhydramine, Methapyrilene, and Placebo re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis)",Supporting & Related Material,Background Material,2011-02-17T05:00:00Z,2011,2,,,2018-01-02T15:06:38Z,,0,0,09000064805c22d5 FDA-1975-N-0017-0071,FDA,FDA-1975-N-0017,Request for Hearing from The Proprietary Association,Other,Request for Hearing,2011-02-17T05:00:00Z,2011,2,2011-02-17T05:00:00Z,,2017-12-29T20:44:40Z,,0,0,09000064805c22e8 FDA-1975-N-0017-0067,FDA,FDA-1975-N-0017,Objection from Center for Science In The Public Interest,Other,Objection(s),2011-02-17T05:00:00Z,2011,2,2011-02-17T05:00:00Z,,2018-01-02T13:31:54Z,,0,0,09000064805c22de FDA-1975-N-0017-0068,FDA,FDA-1975-N-0017,Objection from Children's Hospital Medical Center,Other,Objection(s),2011-02-17T05:00:00Z,2011,2,2011-02-17T05:00:00Z,,2018-01-02T13:27:50Z,,0,0,09000064805c22e1 FDA-1975-N-0017-0055,FDA,FDA-1975-N-0017,"Proposal To Establish Monographs For OTC Nighttime Sleep-Aid, Daytime Sedative, And Stimulant Products (Part 1)",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-02-07T05:00:00Z,2011,2,2011-02-07T05:00:00Z,1976-03-09T04:59:59Z,2018-01-24T21:03:21Z,75-32774,0,0,09000064805c22a6 FDA-1975-N-0017-0058,FDA,FDA-1975-N-0017,"Memorandum of Telephone Conversation between Weil, Guttman & Davis and FDA",Other,Memorandum,2011-02-07T05:00:00Z,2011,2,2011-02-07T05:00:00Z,,2017-11-27T14:03:50Z,,0,0,09000064805c22ab FDA-1975-N-0017-0057,FDA,FDA-1975-N-0017,"Proposal To Establish Monographs For OTC Nighttime Sleep-Aid, Daytime Sedative, And Stimulant Products; Correction",Notice,,2011-02-07T00:00:00Z,2011,2,,,2023-11-03T14:47:22Z,,0,1,09000064805c22a9 FDA-1975-N-0017-0052,FDA,FDA-1975-N-0017,Supplement from McNeil Consumer Healthcare (Response to Request for Information),Other,Supplement (SUP),2010-08-13T04:00:00Z,2010,8,2010-08-13T04:00:00Z,,2018-01-30T14:59:35Z,,0,0,0900006480b2f0ce FDA-1975-N-0017-0053,FDA,FDA-1975-N-0017,"New Clinical Data on Acetaminophen/Diphenhydramine Combination Products as a Nighttime Sleep-Aid Drug Product for OTC Use re McNeil Consumer Healthcare - Comment, FDA-1975-N-0017-0051",Supporting & Related Material,C-Comment (Supporting and Related Material),2010-08-13T04:00:00Z,2010,8,,,2013-04-12T15:56:31Z,,0,0,0900006480b2ffbf FDA-1975-N-0017-0054,FDA,FDA-1975-N-0017,Table of Contents - Study Numbers... Combination of OTC Nighttime Sleep-Aid and OTC Internal Analgesic(s): Data Supporting Category 1 Designation - [McNeil Consumer Healthcare (Response to Request for Information) - Supplement] re FDA-1975-N-0017-0052 re: Supplement from McNeil Consumer Healthcare (Response to Request for Information),Supporting & Related Material,Studies and Reports,2010-08-13T04:00:00Z,2010,8,,,2018-01-05T14:58:01Z,,0,0,0900006480b2f0cf FDA-1975-N-0017-0050,FDA,FDA-1975-N-0017,See FDA-1975-N-0017-0028,Rule,NFR-Notice of Final Rule,2010-04-09T04:00:00Z,2010,4,2010-04-09T04:00:00Z,,2011-02-08T14:46:37Z,,0,0,0900006480ad3b5e FDA-1975-N-0017-0049,FDA,FDA-1975-N-0017,FDA/CDER to Consumer Healthcare Products Association - Response Letter,Other,LET-Letter,2010-02-17T05:00:00Z,2010,2,2010-02-17T05:00:00Z,,2013-08-11T03:06:52Z,,0,0,0900006480aa6a63 FDA-1975-N-0017-0047,FDA,FDA-1975-N-0017,Protocol Review from Nonprescription Drug Manufacturers Association,Other,Protocol Review,2010-01-21T05:00:00Z,2010,1,2010-01-21T05:00:00Z,,2018-01-02T18:08:41Z,,0,0,09000064805c2428