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withdrawn,object_id FDA-1976-N-0519-0140,FDA,FDA-1976-N-0519,"Petition for Reconsideration from American Council on Regulatory Compliance (the ""ACRC"") to FDA/CDER",Other,Petition for Reconsideration,2017-08-14T04:00:00Z,2017,8,2017-08-14T04:00:00Z,,2017-08-14T11:56:34Z,,0,0,090000648053bd51 FDA-1976-N-0519-0139,FDA,FDA-1976-N-0519,"Petition Approval from FDA/OC to Walt A. Sanders, Esq (Foley & Lardner, LLP)",Other,Approval,2017-08-14T04:00:00Z,2017,8,2017-08-14T04:00:00Z,,2017-08-14T11:52:58Z,,0,0,090000648053bd5f FDA-1976-N-0519-0130,FDA,FDA-1976-N-0519,"Tab 4 - Medical/Dental Report, Vol. 233-245 re Comment from Richardson-Vicks U.S.A",Supporting & Related Material,Background Material,2011-05-25T04:00:00Z,2011,5,,,2016-03-08T16:49:34Z,,0,0,090000648053bcd0 FDA-1976-N-0519-0136,FDA,FDA-1976-N-0519,Tab 11 - Inter-Dapartment Memo Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-25T04:00:00Z,2011,5,,,2016-03-08T16:58:48Z,,0,0,090000648053bcd6 FDA-1976-N-0519-0129,FDA,FDA-1976-N-0519,"Tab 3 - National Colds/Flu Incidence Survey - [Crossley Services, Inc] - re Comment from Richardson-Vicks U.S.A.",Supporting & Related Material,Background Material,2011-05-25T04:00:00Z,2011,5,,,2016-03-08T16:48:51Z,,0,0,090000648053bcd1 FDA-1976-N-0519-0133,FDA,FDA-1976-N-0519,Tab 8 - Bristrol-Myers Products re Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-25T04:00:00Z,2011,5,,,2016-03-08T16:55:22Z,,0,0,090000648053bcd9 FDA-1976-N-0519-0131,FDA,FDA-1976-N-0519,Tab 6 - Vicks Research Center - Medical Department re Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-25T04:00:00Z,2011,5,,,2016-03-08T16:51:10Z,,0,0,090000648053bcdb FDA-1976-N-0519-0137,FDA,FDA-1976-N-0519,Appendix IX re Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-25T04:00:00Z,2011,5,,,2016-03-08T16:56:51Z,,0,0,090000648053bcd5 FDA-1976-N-0519-0132,FDA,FDA-1976-N-0519,Tab 7 - Kaskuba to Ms. Kelly re Comment from Richardson-Vicks U.S.A,Supporting & Related Material,Background Material,2011-05-25T04:00:00Z,2011,5,,,2016-03-08T16:52:20Z,,0,0,090000648053bcda FDA-1976-N-0519-0134,FDA,FDA-1976-N-0519,Tab 9 - Vicks Research Center re Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-25T04:00:00Z,2011,5,,,2016-03-08T17:01:34Z,,0,0,090000648053bcd8 FDA-1976-N-0519-0135,FDA,FDA-1976-N-0519,Tab 10 - A Symptomotology Profile of Colds Sufferers re Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-25T04:00:00Z,2011,5,,,2016-03-08T16:59:47Z,,0,0,090000648053bcd7 FDA-1976-N-0519-0128,FDA,FDA-1976-N-0519,"Tab 1 - Federal Register, Vol 41, NO. 176 - Thursday, September 9, 1976 re Comment from Richardson-Vicks U.S.A.",Supporting & Related Material,Background Material,2011-05-23T04:00:00Z,2011,5,,,2016-03-08T16:46:57Z,,0,0,090000648053bcd3 FDA-1976-N-0519-0127,FDA,FDA-1976-N-0519,Tab 5 - Vicks Divisons Research and Development re Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-23T04:00:00Z,2011,5,,,2016-03-08T16:50:10Z,,0,0,090000648053bcce FDA-1976-N-0519-0121,FDA,FDA-1976-N-0519,Tab 3 - No Material Submittee re Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-04T04:00:00Z,2011,5,,,2016-03-03T19:44:40Z,,0,0,0900006480c3f46c FDA-1976-N-0519-0123,FDA,FDA-1976-N-0519,Tab 4 - CRD #87-25 VapoRub Nasal Decongestant re Comment Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-04T04:00:00Z,2011,5,,,2016-03-03T19:37:53Z,,0,0,0900006480c3f48f FDA-1976-N-0519-0122,FDA,FDA-1976-N-0519,CRD #89-01 Re Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-04T04:00:00Z,2011,5,,,2016-03-03T19:39:43Z,,0,0,0900006480c3f46f FDA-1976-N-0519-0124,FDA,FDA-1976-N-0519,Tab 5 - VapoRub Nasal Decongestant - Table 5 re Comment from Richardson-Vicks U.S.A.,Supporting & Related Material,Background Material,2011-05-04T04:00:00Z,2011,5,,,2016-03-03T19:54:17Z,,0,0,0900006480c3f493 FDA-1976-N-0519-0115,FDA,FDA-1976-N-0519,Appendix IV Sample Case Report Form re Comment from Whitehall Laboratories Division of American Home Products Corporation,Supporting & Related Material,Background Material,2011-04-26T04:00:00Z,2011,4,,,2016-03-04T15:49:01Z,,0,0,0900006480c39569 FDA-1976-N-0519-0114,FDA,FDA-1976-N-0519,Appendix III Protocol re Comment from Whitehall Laboratories Division of American Home Products Corporation,Supporting & Related Material,Background Material,2011-04-26T04:00:00Z,2011,4,,,2016-03-04T15:47:33Z,,0,0,0900006480c39567 FDA-1976-N-0519-0117,FDA,FDA-1976-N-0519,Appendix C Nasal Congestion Evaluation Protocol No. WM-464 re Comment from Whitehall Laboratories Division of American Home Products Corporation,Supporting & Related Material,Background Material,2011-04-26T04:00:00Z,2011,4,,,2016-03-04T15:53:47Z,,0,0,0900006480c3956e FDA-1976-N-0519-0118,FDA,FDA-1976-N-0519,Appendix D Nasal Congestion Evaluation Patient Diary Protocol No. WM-464 re Comment from Whitehall Laboratories Division of American Home Products Corporation,Supporting & Related Material,Background Material,2011-04-26T04:00:00Z,2011,4,,,2016-03-04T15:55:48Z,,0,0,0900006480c396c1 FDA-1976-N-0519-0116,FDA,FDA-1976-N-0519,Appendix V Sample Data Report Page re Comment from Whitehall Laboratories Division of American Home Products Corporation,Supporting & Related Material,Background Material,2011-04-26T04:00:00Z,2011,4,,,2016-03-04T15:51:28Z,,0,0,0900006480c3956b FDA-1976-N-0519-0119,FDA,FDA-1976-N-0519,"Supplement from Hoffmann-La Roche, Inc.",Other,Supplement (SUP),2011-04-26T04:00:00Z,2011,4,2011-04-26T04:00:00Z,,2016-03-03T16:52:17Z,,0,0,090000648053bcc1 FDA-1976-N-0519-0105,FDA,FDA-1976-N-0519,"Tab R - FDA Summary Basis of Approval, ""Medical Officer's Review of Supplemental NDA"", for Approval of NDA Supplement Permitting Phenergan VC to be Sold OTC re Comment Wyeth-Ayerst Laboratories Divison of American Home Products Corporation",Supporting & Related Material,Reply Comment (RC),2011-04-25T04:00:00Z,2011,4,,,2018-02-14T16:53:17Z,,0,0,0900006480c37549 FDA-1976-N-0519-0101,FDA,FDA-1976-N-0519,Index to Appendices re Reply Comment Wyeth-Ayerst Laboratories Divison of American Home Products Corporation,Supporting & Related Material,Reply Comment (RC),2011-04-25T04:00:00Z,2011,4,,,2018-02-14T16:34:09Z,,0,0,0900006480c36cc8 FDA-1976-N-0519-0110,FDA,FDA-1976-N-0519,"Appendix E Narrative case-by-case summaries of 31 Adverse Reaction Reports, cited in Public Citizen's Petition re Reply Comment from Wyeth-Ayerst Laboratories",Supporting & Related Material,Background Material,2011-04-25T04:00:00Z,2011,4,,,2016-03-24T14:35:16Z,,0,0,0900006480c37864 FDA-1976-N-0519-0106,FDA,FDA-1976-N-0519,Report from O'Connor Pharmaceuticals,Other,Report,2011-04-25T04:00:00Z,2011,4,2011-04-25T04:00:00Z,,2016-03-03T16:19:55Z,,0,0,090000648053bcae FDA-1976-N-0519-0104,FDA,FDA-1976-N-0519,"Tab K - Letters by Max J. Michels, M.D., Feb. 14, 1989; William Schwartz, M.D., Feb. 21, 1989; and Jeffrey M. Greene, M.D., Feb. 10, 1989 re Comment from Wyeth-Ayerst Laboratories Divison of American Home Products Corporation",Supporting & Related Material,Reply Comment (RC),2011-04-25T04:00:00Z,2011,4,,,2018-02-14T16:49:25Z,,0,0,0900006480c3750b FDA-1976-N-0519-0111,FDA,FDA-1976-N-0519,"Appendix F Summary of Post-1985 Adverse Drug Reaction Reports, and tabulation of non-15 day Adverse Reaction Reports received since 1985, all oral dosage of promethazine re Reply Comment from Wyeth-Ayerst Laboratories",Supporting & Related Material,Background Material,2011-04-25T04:00:00Z,2011,4,,,2016-03-24T14:37:45Z,,0,0,0900006480c378ad FDA-1976-N-0519-0108,FDA,FDA-1976-N-0519,Reply Comment re Index to Appendices Wyeth-Ayerst Laboratories,Supporting & Related Material,Reply Comment (RC),2011-04-25T04:00:00Z,2011,4,,,2016-03-24T15:00:56Z,,0,0,0900006480c377d5 FDA-1976-N-0519-0102,FDA,FDA-1976-N-0519,"Tab B - Letter from Arnold & Porter, May 15, 1985 re Reply Comment from Wyeth-Ayerst Laboratories Divison of American Home Products Corporation",Supporting & Related Material,Reply Comment (RC),2011-04-25T04:00:00Z,2011,4,,,2018-02-14T16:37:00Z,,0,0,0900006480c36ccc FDA-1976-N-0519-0109,FDA,FDA-1976-N-0519,"Appendix C Letter from Alan R. Spitzer, M.D. To Marc Deitch, M.D. dated April 24, 1989 re Reply Comment from Wyeth-Ayerst Laboratories",Supporting & Related Material,Background Material,2011-04-25T04:00:00Z,2011,4,,,2016-03-04T16:22:32Z,,0,0,0900006480c3785f FDA-1976-N-0519-0098,FDA,FDA-1976-N-0519,Attachment I - Clinical-Biostatistical Report re Comment from Whitehall Laboratories,Supporting & Related Material,Background Material,2011-04-22T04:00:00Z,2011,4,,,2016-03-02T20:53:07Z,,0,0,0900006480c35ae3 FDA-1976-N-0519-0096,FDA,FDA-1976-N-0519,Table of Contents - (3 of 3) - [ Exhbit B - Comment 192],Supporting & Related Material,Background Material,2011-04-21T04:00:00Z,2011,4,,,2016-03-02T19:20:42Z,,0,0,0900006480c34fce FDA-1976-N-0519-0094,FDA,FDA-1976-N-0519,Table of Contents - (2 of 3) - [ Exhbit B - Comment 192],Supporting & Related Material,Background Material,2011-04-06T04:00:00Z,2011,4,,,2016-03-02T19:13:27Z,,0,0,0900006480c1cbf7 FDA-1976-N-0519-0095,FDA,FDA-1976-N-0519,Tedral Review of Clinical Literature - [Table of Contents - (2 of 3) - [ Exhbit B - Comment 192],Supporting & Related Material,Background Material,2011-04-06T04:00:00Z,2011,4,,,2016-03-02T19:18:42Z,,0,0,0900006480c1cc12 FDA-1976-N-0519-0093,FDA,FDA-1976-N-0519,"Comment from Exhibit A - Federal Register/ Vol 53. No. 156/ Friday , August 12, 1988/ Proposed Rule - [ Comment 192]",Supporting & Related Material,Background Material,2011-03-28T04:00:00Z,2011,3,,,2016-03-04T16:08:08Z,,0,0,0900006480c11f83 FDA-1976-N-0519-0074,FDA,FDA-1976-N-0519,Acknowledgment Letter from FDA/DDM to Public Citizen Health Research Group,Other,Acknowledgement Letter/Receipt,2011-03-25T04:00:00Z,2011,3,2011-03-25T04:00:00Z,,2016-03-11T19:00:46Z,,0,0,090000648053bc9b FDA-1976-N-0519-0066,FDA,FDA-1976-N-0519,Letter from FDA/CDER to Public Citizen Health Research Group,Other,Letter(s),2011-03-25T04:00:00Z,2011,3,2011-03-25T04:00:00Z,,2016-03-11T16:08:34Z,,0,0,090000648053bcb0 FDA-1976-N-0519-0081,FDA,FDA-1976-N-0519,"Answer from FDA to The Honorable Albert Gore, Jr. re Comment from United States Senate (C 202)",Other,ANS-Answer,2011-03-25T04:00:00Z,2011,3,2011-03-25T04:00:00Z,,2016-03-11T21:32:55Z,,0,0,0900006480c109b8 FDA-1976-N-0519-0065,FDA,FDA-1976-N-0519,Answer from FDA/CDER to Health Protection Branch re {Letter 88},Other,Answer,2011-03-25T04:00:00Z,2011,3,2011-03-25T04:00:00Z,,2016-03-01T18:50:23Z,,0,0,0900006480c1058a FDA-1976-N-0519-0072,FDA,FDA-1976-N-0519,Citizen Petition from Public Citizen Health Research Group,Other,Citizen Petition,2011-03-25T04:00:00Z,2011,3,2011-03-25T04:00:00Z,,2016-03-02T20:35:38Z,,0,0,090000648053bc9a FDA-1976-N-0519-0082,FDA,FDA-1976-N-0519,"Memorandum of Meeting between FDA/CDER and Richardson-Vicks, Inc.",Other,Memorandum,2011-03-25T04:00:00Z,2011,3,2011-03-25T04:00:00Z,,2016-03-02T20:03:11Z,,0,0,090000648053bca2 FDA-1976-N-0519-0064,FDA,FDA-1976-N-0519,Letter from Health & Welfare Canada/Health Protection,Other,Letter(s),2011-03-25T04:00:00Z,2011,3,2011-03-25T04:00:00Z,,2016-03-11T16:08:58Z,,0,0,090000648053bcb1 FDA-1976-N-0519-0079,FDA,FDA-1976-N-0519,Answer from FDA to The Honorable Albert Gore Jr.,Other,ANS-Answer,2011-03-25T04:00:00Z,2011,3,2011-03-25T04:00:00Z,,2016-03-11T21:37:42Z,,0,0,0900006480c109b6 FDA-1976-N-0519-0061,FDA,FDA-1976-N-0519,Letter from Health and Welfare Canada/Health Protection Branch,Other,Letter(s),2011-03-24T04:00:00Z,2011,3,2011-03-24T04:00:00Z,,2016-03-11T16:09:26Z,,0,0,090000648053bcb4 FDA-1976-N-0519-0045,FDA,FDA-1976-N-0519,"Letter from Richardson-Vicks, Inc.",Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:14:52Z,,0,0,090000648053bce2 FDA-1976-N-0519-0039,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to Richardson-Vicks, Inc.",Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T15:55:50Z,,0,0,090000648053bce7 FDA-1976-N-0519-0033,FDA,FDA-1976-N-0519,Letter from FDA/CDER to Wyeth-Ayerst Laboratories,Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:18:40Z,,0,0,090000648053bcf0 FDA-1976-N-0519-0036,FDA,FDA-1976-N-0519,Request for Extension from Wyeth-Ayerst Laboratories,Other,Request for Extension,2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-02T16:20:11Z,,0,0,090000648053bceb FDA-1976-N-0519-0049,FDA,FDA-1976-N-0519,"Letter from Richardson-Vicks, U. S. A.",Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:13:32Z,,0,0,090000648053bcdd FDA-1976-N-0519-0054,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to Pharmaceutical Basic, Inc.",Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:12:30Z,,0,0,090000648053bcbb FDA-1976-N-0519-0051,FDA,FDA-1976-N-0519,"Correction from Richardson-Vicks, U. S. A.",Other,Correction(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-01T21:26:21Z,,0,0,090000648053bcbe FDA-1976-N-0519-0057,FDA,FDA-1976-N-0519,Letter from FDA/CDER to Halsey Drug Co. Inc.,Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:11:16Z,,0,0,090000648053bcb8 FDA-1976-N-0519-0060,FDA,FDA-1976-N-0519,Letter from FDA/CDER to Public Citizen Health Research Group,Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:10:02Z,,0,0,090000648053bcb5 FDA-1976-N-0519-0056,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to H.R Cenci Laboratories, Inc.",Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:19:47Z,,0,0,090000648053bcb9 FDA-1976-N-0519-0055,FDA,FDA-1976-N-0519,Letter from FDA/CDER to Nonprescription Drug Manufactures Association,Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:20:30Z,,0,0,090000648053bcba FDA-1976-N-0519-0040,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to Vicks Research Services (Richardson-Vicks, Inc)",Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T15:53:43Z,,0,0,090000648053bce6 FDA-1976-N-0519-0046,FDA,FDA-1976-N-0519,"Notice re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Combination Drug Products Containing Promethazine Hydrochloride; Marketing Status",Notice,General Notice,2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-02T21:34:25Z,,0,0,090000648053bce1 FDA-1976-N-0519-0031,FDA,FDA-1976-N-0519,"Notice of Proposed Rule-Making re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use, Reopening Of Record For Receipt Of Comments Regarding The Marketing Status Of Combination Drug Products Containing Promethazine Hydrochloride; Correction",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-02T16:28:24Z,,0,0,090000648053bcee FDA-1976-N-0519-0043,FDA,FDA-1976-N-0519,Answer from FDA/CDER to Clinton Prescriptions & Surgical Supply,Other,Answer,2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-01T21:56:32Z,,0,0,0900006480c0e79c FDA-1976-N-0519-0044,FDA,FDA-1976-N-0519,Memorandum of Telephone Conversation between FDA/CDER and Wyeth-Ayerst,Other,Memorandum,2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-01T21:51:58Z,,0,0,090000648053bce3 FDA-1976-N-0519-0050,FDA,FDA-1976-N-0519,Request for Extension from O'Conner Pharmaceuticals,Other,Request for Extension,2011-03-23T04:00:00Z,2011,3,2005-07-12T04:00:00Z,2005-11-11T04:59:59Z,2016-03-11T15:35:10Z,,0,0,090000648053bcbf FDA-1976-N-0519-0047,FDA,FDA-1976-N-0519,Letter from FDA/CDER to O'Conner Pharmaceuticals,Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:14:15Z,,0,0,090000648053bce0 FDA-1976-N-0519-0041,FDA,FDA-1976-N-0519,Letter from FDA/CDER to Public Citizen Health Research Group,Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T15:51:05Z,,0,0,090000648053bce5 FDA-1976-N-0519-0032,FDA,FDA-1976-N-0519,"Notice of Extension re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use; Reopening Of Record For Receipt Of Comments Regarding The Marketing Status Of Combination Drug Products Containing Promethazine Hydrochloride; Extension Of Comment Period",Proposed Rule,Extension of Comment Period,2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,1990-05-30T03:59:59Z,2016-03-02T18:53:21Z,,0,0,090000648053bcf1 FDA-1976-N-0519-0034,FDA,FDA-1976-N-0519,"Supplement from Richardson-Vicks, U. S. A.",Other,Supplement (SUP),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-31T18:54:53Z,,0,0,090000648053bcef FDA-1976-N-0519-0038,FDA,FDA-1976-N-0519,Memorandum of Telephone Conversation between HFD-210 and HFA-305,Other,Memorandum,2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T15:58:10Z,,0,0,090000648053bce8 FDA-1976-N-0519-0035,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to Richardson-Vicks, Inc.",Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:02:04Z,,0,0,090000648053bced FDA-1976-N-0519-0058,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to Barre-National, Inc.",Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:10:34Z,,0,0,090000648053bcb7 FDA-1976-N-0519-0053,FDA,FDA-1976-N-0519,Letter from FDA/CDER to Wyeth-Ayerst Research,Other,Letter(s),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T16:13:02Z,,0,0,090000648053bcbc FDA-1976-N-0519-0052,FDA,FDA-1976-N-0519,"Appearance Request from Richardson-Vicks, U. S. A.",Other,Appearance Request,2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,,2016-03-11T15:29:45Z,,0,0,090000648053bcbd FDA-1976-N-0519-0037,FDA,FDA-1976-N-0519,"Notice of Proposed Rule-Making re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use, Reopening Of Record For Receipt Of Comments Regarding The Marketing Status Of Combination Drug Products Containing Promethazine Hydrochloride",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-03-23T04:00:00Z,2011,3,2011-03-23T04:00:00Z,1990-01-21T04:59:59Z,2016-03-02T16:15:25Z,,0,0,090000648053bcea FDA-1976-N-0519-0027,FDA,FDA-1976-N-0519,"Letter from Vicks Research Center/Richardson-Vicks, Inc.",Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-01T19:36:09Z,,0,0,090000648053bc89 FDA-1976-N-0519-0022,FDA,FDA-1976-N-0519,"Letter from Vicks Research Center/Richardson-Vicks, Inc.",Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-01T19:56:38Z,,0,0,090000648053bc84 FDA-1976-N-0519-0023,FDA,FDA-1976-N-0519,"Letter from Vicks Research Center/Richardson-Vicks, Inc.",Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-01T19:52:49Z,,0,0,090000648053bc85 FDA-1976-N-0519-0024,FDA,FDA-1976-N-0519,Memorandum of Meeting between FDA/CDER and Vicks Research Center,Other,Memorandum,2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-08T19:31:13Z,,0,0,090000648053bc86 FDA-1976-N-0519-0018,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to Vicks Research Center-Richardson Vicks, Inc.",Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-08T19:28:17Z,,0,0,090000648053bc80 FDA-1976-N-0519-0028,FDA,FDA-1976-N-0519,"Answer from FDA/HFN-510 (Gilbertson) to Richardson-Vicks, Inc.",Other,Answer,2011-03-22T04:00:00Z,2011,3,2011-03-18T04:00:00Z,1988-12-13T04:59:59Z,2016-03-08T19:38:19Z,,0,0,090000648053bc8a FDA-1976-N-0519-0020,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to Vicks Research Center-Richardson Vicks, Inc.",Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-08T19:29:10Z,,0,0,090000648053bc82 FDA-1976-N-0519-0026,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to Richardson-Vicks, Inc.",Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-01T19:41:42Z,,0,0,090000648053bc88 FDA-1976-N-0519-0025,FDA,FDA-1976-N-0519,"Letter from Vicks Research Center - Richardson Vicks, Inc.",Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-08T19:33:27Z,,0,0,090000648053bc87 FDA-1976-N-0519-0019,FDA,FDA-1976-N-0519,Letter from FDA/CDER to Bristol-Myers Company,Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-08T19:28:37Z,,0,0,090000648053bc81 FDA-1976-N-0519-0029,FDA,FDA-1976-N-0519,"Letter from Richardson-Vicks, Inc.",Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-01T19:25:14Z,,0,0,090000648053bc8b FDA-1976-N-0519-0030,FDA,FDA-1976-N-0519,Memorandum of Meeting re FDA/Office of the Commissioner,Other,Memorandum,2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-01T19:19:00Z,,0,0,090000648053bc8c FDA-1976-N-0519-0021,FDA,FDA-1976-N-0519,"Letter from FDA/CDER to Richardson-Vicks, Inc.",Other,Letter(s),2011-03-22T04:00:00Z,2011,3,2011-03-22T04:00:00Z,,2016-03-08T19:29:34Z,,0,0,090000648053bc83 FDA-1976-N-0519-0014,FDA,FDA-1976-N-0519,Environmental Assessment re FDA/Center for Drug Evaluation and Research,Supporting & Related Material,Environmental Assessment,2011-03-18T04:00:00Z,2011,3,,,2016-03-01T18:55:56Z,,0,0,090000648053bc8e FDA-1976-N-0519-0012,FDA,FDA-1976-N-0519,"Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The Counter Human Use; Tentative Final Monograph For Combination Drug Products; Clarification",Notice,General Notice,2011-03-18T04:00:00Z,2011,3,2011-03-18T04:00:00Z,1988-12-13T04:59:59Z,2016-02-23T22:00:30Z,,0,0,090000648053bc90 FDA-1976-N-0519-0013,FDA,FDA-1976-N-0519,"Notice of Proposed Rulemaking re Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The Counter Human Use; Tentative Final Monograph For Combination Drug Products",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-03-18T04:00:00Z,2011,3,2011-03-18T04:00:00Z,1988-12-13T04:59:59Z,2018-12-20T02:02:21Z,,0,0,090000648053bc8f FDA-1976-N-0519-0015,FDA,FDA-1976-N-0519,Finding of No Significant Impact re FDA/Center for Drug Evaulation and Research,Supporting & Related Material,Finding of no Significant Impact,2011-03-18T04:00:00Z,2011,3,,,2016-03-01T18:28:18Z,,0,0,090000648053bc8d FDA-1976-N-0519-0011,FDA,FDA-1976-N-0519,Response Letter from FDA to The Honorable Arlen Specter,Other,Letter(s),2009-10-20T04:00:00Z,2009,10,2009-10-20T04:00:00Z,,2016-03-02T21:24:49Z,,0,0,0900006480a46971 FDA-1976-N-0519-0010,FDA,FDA-1976-N-0519,Letter from The Honorable Arlen Specter (on Behalf of Lehigh Valley Technologies) to FDA,Other,Letter(s),2009-10-20T04:00:00Z,2009,10,2009-10-20T04:00:00Z,,2016-03-07T15:44:17Z,,0,0,0900006480a4696f FDA-1976-N-0519-0009,FDA,FDA-1976-N-0519,Notice of Final Rule re Over-the-Counter (OTC) General Comments & Combinations,Rule,Final Rule,2007-03-19T04:00:00Z,2007,3,2007-03-16T04:00:00Z,,2016-03-07T16:13:51Z,,0,0,090000648053bd5c FDA-1976-N-0519-0008,FDA,FDA-1976-N-0519,"Acknowledgement Letter from FDA/DDM to Foley & Lardner, LLP",Other,Acknowledgement Letter/Receipt,2005-12-09T05:00:00Z,2005,12,,,2016-02-23T21:34:28Z,,0,0,090000648053bd53 FDA-1976-N-0519-0007,FDA,FDA-1976-N-0519,"Acknowledgement Letter from FDA/DDM to Foley & Lardner, LLP",Other,Acknowledgement Letter/Receipt,2005-12-09T05:00:00Z,2005,12,,,2016-03-08T16:10:22Z,,0,0,090000648053bd52 FDA-1976-N-0519-0006,FDA,FDA-1976-N-0519,Memorandum from FDA/ OC to FDA/DDM,Other,Memorandum,2005-11-02T05:00:00Z,2005,11,,,2016-03-08T16:28:44Z,,0,0,090000648053bd3e FDA-1976-N-0519-0005,FDA,FDA-1976-N-0519,Memorandum of Telephone Conversation Between Barnes & Thornburg LLP and FDA/CDER,Other,Memorandum,2005-10-05T04:00:00Z,2005,10,,,2016-02-23T21:15:35Z,,0,0,090000648053bd35 FDA-1976-N-0519-0004,FDA,FDA-1976-N-0519,Memorandum of Telephone Conversation Between Barnes & Thornburg LLP and FDA/CDER,Other,Memorandum,2005-10-05T04:00:00Z,2005,10,,,2016-03-07T19:01:12Z,,0,0,090000648053bd34 FDA-1976-N-0519-0003,FDA,FDA-1976-N-0519,"Notice of Proposed Rulemaking re Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph for Combination Drug Products",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2005-07-15T04:00:00Z,2005,7,2005-07-12T04:00:00Z,2005-11-11T04:59:59Z,2018-12-20T02:03:42Z,,0,0,090000648053bd30 FDA-1976-N-0519-0002,FDA,FDA-1976-N-0519,"Memorandum of Meeting between FDA/CDER and Lil' Drug Store, Inc.",Other,Memorandum,2003-10-21T04:00:00Z,2003,10,,,2016-03-08T19:24:17Z,,0,0,090000648053bd1d