{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-1976-N-0519\" sorted by posted_date descending", "rows": [["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", null, "2017-08-14T11:56:34Z", null, 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", null, "2017-08-14T11:52:58Z", null, 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, null, null, "2016-03-08T16:49:34Z", null, 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, null, null, "2016-03-08T16:58:48Z", null, 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, null, null, "2016-03-08T16:48:51Z", null, 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, null, null, "2016-03-08T16:55:22Z", null, 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, null, null, "2016-03-08T16:51:10Z", null, 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, null, null, "2016-03-08T16:56:51Z", null, 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, null, null, "2016-03-08T16:52:20Z", null, 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, null, null, "2016-03-08T17:01:34Z", null, 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, null, null, "2016-03-08T16:59:47Z", null, 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, null, null, "2016-03-08T16:46:57Z", null, 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, null, null, "2016-03-08T16:50:10Z", null, 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, null, null, "2016-03-03T19:44:40Z", null, 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, null, null, "2016-03-03T19:37:53Z", null, 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, null, null, "2016-03-03T19:39:43Z", null, 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, null, null, "2016-03-03T19:54:17Z", null, 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, null, null, "2016-03-04T15:49:01Z", null, 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, null, null, "2016-03-04T15:47:33Z", null, 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, null, null, "2016-03-04T15:53:47Z", null, 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, null, null, "2016-03-04T15:55:48Z", null, 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, null, null, "2016-03-04T15:51:28Z", null, 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", null, "2016-03-03T16:52:17Z", null, 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, null, null, "2018-02-14T16:53:17Z", null, 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, null, null, "2018-02-14T16:34:09Z", null, 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, null, null, "2016-03-24T14:35:16Z", null, 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", null, "2016-03-03T16:19:55Z", null, 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, null, null, "2018-02-14T16:49:25Z", null, 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, null, null, "2016-03-24T14:37:45Z", null, 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, null, null, "2016-03-24T15:00:56Z", null, 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, null, null, "2018-02-14T16:37:00Z", null, 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, null, null, "2016-03-04T16:22:32Z", null, 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, null, null, "2016-03-02T20:53:07Z", null, 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, null, null, "2016-03-02T19:20:42Z", null, 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, null, null, "2016-03-02T19:13:27Z", null, 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, null, null, "2016-03-02T19:18:42Z", null, 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, null, null, "2016-03-04T16:08:08Z", null, 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", null, "2016-03-11T19:00:46Z", null, 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", null, "2016-03-11T16:08:34Z", null, 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", null, "2016-03-11T21:32:55Z", null, 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", null, "2016-03-01T18:50:23Z", null, 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", null, "2016-03-02T20:35:38Z", null, 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", null, "2016-03-02T20:03:11Z", null, 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", null, "2016-03-11T16:08:58Z", null, 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", null, "2016-03-11T21:37:42Z", null, 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", null, "2016-03-11T16:09:26Z", null, 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", null, "2016-03-11T16:14:52Z", null, 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", null, "2016-03-11T15:55:50Z", null, 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", null, "2016-03-11T16:18:40Z", null, 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", null, "2016-03-02T16:20:11Z", null, 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", null, "2016-03-11T16:13:32Z", null, 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", null, "2016-03-11T16:12:30Z", null, 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", null, "2016-03-01T21:26:21Z", null, 0, 0, "090000648053bcbe"], ["FDA-1976-N-0519-0057", "FDA", "FDA-1976-N-0519", "Letter from FDA/CDER to Halsey Drug Co. 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