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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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101 rows where docket_id = "FDA-1976-N-0519" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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 Over-the-Counter (OTC) General Comments & Combinations - OPEN 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);