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withdrawn,object_id FDA-1976-N-0027-0208,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 9,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T18:38:37Z,,0,0,090000648051b942 FDA-1976-N-0027-0185,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 1,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T19:00:09Z,,0,0,090000648051b929 FDA-1976-N-0027-0183,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 25,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T20:54:46Z,,0,0,090000648051b925 FDA-1976-N-0027-0182,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 24,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T16:26:41Z,,0,0,090000648051b924 FDA-1976-N-0027-0184,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 5,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T18:48:36Z,,0,0,090000648051b928 FDA-1976-N-0027-0190,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 13,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T21:51:43Z,,0,0,090000648051b930 FDA-1976-N-0027-0198,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 27,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T16:51:03Z,,0,0,090000648051b938 FDA-1976-N-0027-0215,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 17,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T19:39:22Z,,0,0,090000648051b949 FDA-1976-N-0027-0178,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 11,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T18:58:23Z,,0,0,090000648051b920 FDA-1976-N-0027-0181,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 23,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T16:14:32Z,,0,0,090000648051b923 FDA-1976-N-0027-0211,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 13,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T19:12:05Z,,0,0,090000648051b945 FDA-1976-N-0027-0189,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 3,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T15:58:39Z,,0,0,090000648051b92f FDA-1976-N-0027-0177,FDA,FDA-1976-N-0027,Supplemnet from Consumer Healthcare Products Association - Appendix 2: Part 20,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T20:37:30Z,,0,0,090000648051b91f FDA-1976-N-0027-0201,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 2,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T16:09:57Z,,0,0,090000648051b93b FDA-1976-N-0027-0191,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 4,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T22:08:16Z,,0,0,090000648051b931 FDA-1976-N-0027-0204,FDA,FDA-1976-N-0027,Supplement Consumer Healthcare Products Association - Appendix 2: Part 5,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T15:29:15Z,,0,0,090000648051b93e FDA-1976-N-0027-0186,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 2,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T19:11:16Z,,0,0,090000648051b92a FDA-1976-N-0027-0188,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 11,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T15:26:14Z,,0,0,090000648051b92c FDA-1976-N-0027-0187,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 12,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T19:34:24Z,,0,0,090000648051b92b FDA-1976-N-0027-0176,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 19,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T19:54:36Z,,0,0,090000648051b91e FDA-1976-N-0027-0197,FDA,FDA-1976-N-0027,"Supplemnet from Consumer Healthcare Products Association - Appendix 5 - Meta-analysis of Phenylephrine vs. Placebo, Analysis of Change from Baseline Nasal Airflow Resistance and LN of Ratio (Post-baseline NAR/Baseline NAR); Standard Error of Treatment Response and Upper and Lower 95% Confidence Limits on Treatment Response by Time Point and Model",Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T21:45:48Z,,0,0,090000648051b937 FDA-1976-N-0027-0193,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 15,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T21:21:18Z,,0,0,090000648051b933 FDA-1976-N-0027-0216,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 18,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T19:48:29Z,,0,0,090000648051b94a FDA-1976-N-0027-0212,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 14,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T19:15:12Z,,0,0,090000648051b946 FDA-1976-N-0027-0205,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 6,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T16:39:19Z,,0,0,090000648051b93f FDA-1976-N-0027-0203,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 4,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T16:58:11Z,,0,0,090000648051b93d FDA-1976-N-0027-0196,FDA,FDA-1976-N-0027,"Supplement from Consumer Healthcare Products Association - Appendix 4.2 - Meta-analysis of Phenylephrine vs. Placebo, Analysis of Change from Baseline Nasal Airflow Resistance and LN of Ratio (Post-baseline NAR/Baseline NAR) by Study and Time Point",Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T18:19:08Z,,0,0,090000648051b936 FDA-1976-N-0027-0195,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 1 - Technical Notes; SAS Version 8.2 Models,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T20:11:16Z,,0,0,090000648051b935 FDA-1976-N-0027-0214,FDA,FDA-1976-N-0027,Supplemnet from Consumer Healthcare Products Association - Appendix 2: Part 16,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T19:27:36Z,,0,0,090000648051b948 FDA-1976-N-0027-0202,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 3,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T16:54:57Z,,0,0,090000648051b93c FDA-1976-N-0027-0192,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 3: Part 14,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T21:32:11Z,,0,0,090000648051b932 FDA-1976-N-0027-0207,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 8,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T18:43:28Z,,0,0,090000648051b941 FDA-1976-N-0027-0210,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 12,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T19:01:46Z,,0,0,090000648051b944 FDA-1976-N-0027-0179,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 22,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T20:35:58Z,,0,0,090000648051b921 FDA-1976-N-0027-0180,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 21,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-04T20:15:16Z,,0,0,090000648051b922 FDA-1976-N-0027-0194,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 4.1,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T20:01:33Z,,0,0,090000648051b934 FDA-1976-N-0027-0206,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: part 7,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T18:44:48Z,,0,0,090000648051b940 FDA-1976-N-0027-0213,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 15,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T19:19:33Z,,0,0,090000648051b947 FDA-1976-N-0027-0209,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 10,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-12-14T18:42:23Z,,0,0,090000648051b943 FDA-1976-N-0027-0200,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 1,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T16:38:09Z,,0,0,090000648051b93a FDA-1976-N-0027-0174,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,2008-10-20T04:00:00Z,,2015-10-29T20:36:44Z,,0,0,090000648051b926 FDA-1976-N-0027-0199,FDA,FDA-1976-N-0027,Supplement from Consumer Healthcare Products Association - Appendix 2: Part 26,Other,Supplement (SUP),2008-10-20T04:00:00Z,2008,10,,,2015-11-03T17:01:28Z,,0,0,090000648051b939 FDA-1976-N-0027-0168,FDA,FDA-1976-N-0027,"Attachment: DfK PSE/ PE Comparison, 2006 re Comment from Wyeth Consumer Healthcare",Supporting & Related Material,Electronic Comment (EC),2008-10-16T04:00:00Z,2008,10,,,2015-12-18T15:16:09Z,,0,0,090000648051b8de FDA-1976-N-0027-0171,FDA,FDA-1976-N-0027,"Comment from Consumer Healthcare Products Association (CHPA) - Enclosure 3: Letter to Heinz Schneider from Dallas E. Johnson; January 18, 2007",Other,Letter,2008-10-16T04:00:00Z,2008,10,,,2015-12-19T22:58:34Z,,0,0,090000648051b916 FDA-1976-N-0027-0165,FDA,FDA-1976-N-0027,Attachment 2 to Citizen Petition from Wyeth: Side-by-Side Textual Comparison of 2001 NOOH and 2005 NPRM,Supporting & Related Material,Background Material,2008-10-16T04:00:00Z,2008,10,,,2015-12-10T14:10:36Z,,0,0,090000648051b7a1 FDA-1976-N-0027-0167,FDA,FDA-1976-N-0027,Comment from Wyeth Consumer Healthcare Phenylephrine Review,Supporting & Related Material,Electronic Comment (EC),2008-10-16T04:00:00Z,2008,10,,,2015-12-18T14:55:44Z,,0,0,090000648051b8dc FDA-1976-N-0027-0169,FDA,FDA-1976-N-0027,"Letter from Nelson Mullins Riley & Scarborough, LLP",Other,Letter(s),2008-10-16T04:00:00Z,2008,10,2008-10-16T04:00:00Z,,2015-11-25T18:14:51Z,,0,0,090000648051b914 FDA-1976-N-0027-0172,FDA,FDA-1976-N-0027,Memorandum re Phenylephrine meta-analysis,Supporting & Related Material,Background Material,2008-10-16T04:00:00Z,2008,10,,,2015-12-15T15:33:12Z,,0,0,090000648051b919 FDA-1976-N-0027-0159,FDA,FDA-1976-N-0027,Citizen Petition from Wyeth,Other,Citizen Petition,2008-10-16T04:00:00Z,2008,10,2008-10-16T04:00:00Z,,2015-11-25T16:58:12Z,,0,0,090000648051b7a3 FDA-1976-N-0027-0166,FDA,FDA-1976-N-0027,Attachment: Study - CSR AHR G1-A Protocol 01 re Comment from Wyeth Consumer Healthcare,Supporting & Related Material,Electronic Comment (EC),2008-10-16T04:00:00Z,2008,10,,,2015-12-18T14:58:46Z,,0,0,090000648051b8db FDA-1976-N-0027-0173,FDA,FDA-1976-N-0027,Comment from Consumer Healthcare Products Association CHPA Phenylephrine Task Group,Supporting & Related Material,Background Material,2008-10-16T04:00:00Z,2008,10,,,2015-12-09T19:01:38Z,,0,0,090000648051b91a FDA-1976-N-0027-0158,FDA,FDA-1976-N-0027,References 1-15 Background Information to NPR4,Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-15T18:55:56Z,,0,0,090000648051b797 FDA-1976-N-0027-0155,FDA,FDA-1976-N-0027,"Background Information to NPR4 References 1-15 - Reference 2 - Horwitz et al., ""Phenylpropanolamine & Risk of Hemorrhagic Stroke: Final Report of The Hemorrhagic Stroke Project,"" May 10, 2000 in Comment No. C230, Docket No. 1976N-0052N (formerly Docket No. 76N-052N) and Comment No. RPT14, Docket No. 1981N-0022 (formerly Docket No. 81N-0022)",Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-18T16:39:40Z,,0,0,090000648051b78e FDA-1976-N-0027-0149,FDA,FDA-1976-N-0027,"Background Information to NPR4 References 1-15 - Reference 6 - Food and Drug Administration, Public Health Advisory, ""Safety of Phenylpropanolamine,"" November 6, 2000, Comment No. M1 in Docket No. 1976N-0052N (formerly 76N-052N) and Comment No. M7 in Docket No. 1981N-0022 (formerly 81N-0022)",Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-18T16:57:34Z,,0,0,090000648051b787 FDA-1976-N-0027-0124,FDA,FDA-1976-N-0027,Petition for Stay of Action from Leiner Health Products,Other,Petition for Reconsideration,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-09T21:39:26Z,,0,0,090000648051b693 FDA-1976-N-0027-0156,FDA,FDA-1976-N-0027,"Background Information to NPR4 References 1-15 - Reference 1 - Comment No. LET86, Docket No. 1981N-0022 (formerly Docket No. 81N-0022)",Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-15T18:51:26Z,,0,0,090000648051b78f FDA-1976-N-0027-0153,FDA,FDA-1976-N-0027,"Background Information to NPR4 References 1-15 - Reference 4 - Consumer Healthcare Products Association (CHPA), ""Comments on the Hemmorhagic Stroke Project Report,"" May 24, 2000, in Comment No. C231, Docket No. 1976N-0052N (formerly Docket No. 76N-052N) and Comment No. C113, Docket No. 1981N-0022 (formerly Docket No. 81N-0022)",Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-18T16:51:29Z,,0,0,090000648051b78c FDA-1976-N-0027-0138,FDA,FDA-1976-N-0027,Acknowledgement Letter from FDA/DDM to Bayer Consumer Care Division,Other,Acknowledgement Letter/Receipt,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-25T16:36:14Z,,0,0,090000648051b75d FDA-1976-N-0027-0150,FDA,FDA-1976-N-0027,Background Information to NPR4 References 1 15 Reference 7 Office of Management and Budget Guidelines to Standardized Measures of Costs and Benefits and the Format of Accounting Statements M0008 March 22 2000,Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-15T17:15:33Z,,0,0,090000648051b788 FDA-1976-N-0027-0157,FDA,FDA-1976-N-0027,"Background Information to NPR4 References 1-15 - Reference 13 - U.S. Census Bureau, No. 768, Consumer Price Index by Major Group., accessed June 12, 2001. U.S. Bureau of Labor Statistics, accessed July 23, 2004. Updated 1999 data to 2003 (18.56 percent increase in medical care CPI)",Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-15T18:53:43Z,,0,0,090000648051b793 FDA-1976-N-0027-0146,FDA,FDA-1976-N-0027,Memorandum between FDA and Division of Nonprescription Regulation Development Office of Nonprescription Products re Public Administrative File for Over-the-Counter PPA Containing Drug Products; Tentative Final Monograph,Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-18T16:31:51Z,,0,0,090000648051b790 FDA-1976-N-0027-0148,FDA,FDA-1976-N-0027,"Background Information to NPR4 References 1-15 - - Reference 5 - Transcript of Nonprescription Drugs Advisory Committee meeting, October 19, 2000 (Part3)",Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-15T17:07:47Z,,0,0,090000648051b786 FDA-1976-N-0027-0126,FDA,FDA-1976-N-0027,Acknowledgement Letter from FDA/DDM to Proctor & Gamble Company,Other,Acknowledgement Letter/Receipt,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-25T16:08:54Z,,0,0,090000648051b698 FDA-1976-N-0027-0140,FDA,FDA-1976-N-0027,Answer from FDA/HF-26 to Stanford U School of Medicine,Other,Answer,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-12-14T16:51:24Z,,0,0,090000648051b6c9 FDA-1976-N-0027-0129,FDA,FDA-1976-N-0027,Citizen Petition from Public Citizen's Health Research Group,Other,Citizen Petition,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-25T16:13:18Z,,0,0,090000648051b6b4 FDA-1976-N-0027-0134,FDA,FDA-1976-N-0027,Acknowledgement Letter from FDA/DDM to Public Citizen's Health Research Group,Other,Acknowledgement Letter/Receipt,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-09T16:49:59Z,,0,0,090000648051b6b6 FDA-1976-N-0027-0128,FDA,FDA-1976-N-0027,Memorandum of Meeting Between FDA/CDER and Yale PPA Study,Other,Memorandum,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-10T19:19:10Z,,0,0,090000648051b6a6 FDA-1976-N-0027-0135,FDA,FDA-1976-N-0027,Letter from FDA/CDER - HFD-1 to Public Citizen Health Research Group,Other,Letter(s),2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-25T16:17:47Z,,0,0,090000648051b728 FDA-1976-N-0027-0154,FDA,FDA-1976-N-0027,Background Information to NPR4 References 1-15 - Reference 3 - Phenylpropanolamine case reports from 1991 to 2000 on file in Docket Nos. 1976N-0052N (formerly 76N-052N) and 1981N-0022 (formerly 81N-0022),Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-18T16:48:03Z,,0,0,090000648051b78d FDA-1976-N-0027-0151,FDA,FDA-1976-N-0027,"Background Information to NPR4 References 1-15 - Reference 9 - U.S. Security and Exchange Commission, Form 10-K, Voluntary Market Withdrawals, fiscal year ended December 31, 2000, American Home Products Corp., in Docket Nos. 1976N-0052N (formerly Docket No. 1976N-052N) and 1981N-0022",Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-18T17:01:51Z,,0,0,090000648051b78a FDA-1976-N-0027-0139,FDA,FDA-1976-N-0027,Memorandum of Telephone Conversation Between FDA/CDER & Bayer Corporation,Other,Memorandum,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-25T16:53:21Z,,0,0,090000648051b75e FDA-1976-N-0027-0127,FDA,FDA-1976-N-0027,"Letter from FDA/CDER to Walter N. Kernan, M.D.",Other,Letter(s),2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-09T21:30:29Z,,0,0,090000648051b6a2 FDA-1976-N-0027-0136,FDA,FDA-1976-N-0027,"Acknowledgement Letter from FDA/CDER to Neal C. Murphy, D.D.S, M.S.",Other,Acknowledgement Letter/Receipt,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-25T16:21:22Z,,0,0,090000648051b73c FDA-1976-N-0027-0152,FDA,FDA-1976-N-0027,"Background Information to NPR4 References 1-15 - Reference 5 - Transcript of Nonprescription Drugs Advisory Committee meeting, October 19, 2000 (Part1)",Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-15T17:23:49Z,,0,0,090000648051b78b FDA-1976-N-0027-0147,FDA,FDA-1976-N-0027,"Background Information to NPR4 References 1-15 - Reference 5 - Transcript of Nonprescription Drugs Advisory Committee meeting, October 19, 2000 (Part2)",Supporting & Related Material,Background Material,2008-10-15T04:00:00Z,2008,10,,,2015-12-18T16:55:03Z,,0,0,090000648051b785 FDA-1976-N-0027-0137,FDA,FDA-1976-N-0027,Memorandum of Meeting Between FDA/CDER & Bayer Corporation 2/15/2002,Other,Memorandum,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-25T16:28:02Z,,0,0,090000648051b74d FDA-1976-N-0027-0145,FDA,FDA-1976-N-0027,Acknowledgment Letter from FDA/CDER,Other,Acknowledgement Letter/Receipt,2008-10-15T04:00:00Z,2008,10,,,2015-12-30T15:13:54Z,,0,0,090000648051b73d FDA-1976-N-0027-0125,FDA,FDA-1976-N-0027,Petition for Stay of Action from The Proctor and Gamble Company,Other,Petition for Reconsideration,2008-10-15T04:00:00Z,2008,10,2008-10-15T04:00:00Z,,2015-11-10T15:00:00Z,,0,0,090000648051b696 FDA-1976-N-0027-0084,FDA,FDA-1976-N-0027,"Tab 13 A Multisite Evaluation of the Acute Effects of Phenylpropanolamine in Normal Volunteers. Dr. Paul Robertson, September 6, 1983 - CP7 re Citizen Petition from Thompson Medical Company, Inc.",Supporting & Related Material,Background Material,2008-10-14T04:00:00Z,2008,10,,,2015-12-23T16:54:51Z,,0,0,090000648051b5a5 FDA-1976-N-0027-0107,FDA,FDA-1976-N-0027,"Citizen Petition from Thompson Medical Company, Inc. - CP9 re Appendix IV Continued",Supporting & Related Material,Citizen Petition,2008-10-14T04:00:00Z,2008,10,,,2015-12-22T18:37:45Z,,0,0,090000648051b5ea FDA-1976-N-0027-0119,FDA,FDA-1976-N-0027,"Background Material (04NFMA3) - Memo from Acting Director, Division of OTC Drug Products to Dockets Management",Supporting & Related Material,BKG-Background Material,2008-10-14T04:00:00Z,2008,10,,,2008-10-14T21:02:52Z,,0,0,090000648051b68c FDA-1976-N-0027-0082,FDA,FDA-1976-N-0027,"Tab 11 81N-0022, Vol 2, CP 2 re Citizen Petition from Thompson Medical Company, Inc.",Supporting & Related Material,Background Material,2008-10-14T04:00:00Z,2008,10,,,2015-12-23T16:51:08Z,,0,0,090000648051b5a7 FDA-1976-N-0027-0078,FDA,FDA-1976-N-0027,"Tab 18 A Comparison of the Central Nervous System Stimulatory Activity of Various Anorexiants. Timothy J. Maher, Ph.D., February 6, 1984 - CP7 re comment from Thompson Medical Company, Inc.",Supporting & Related Material,Background Material,2008-10-14T04:00:00Z,2008,10,,,2015-12-23T18:44:27Z,,0,0,090000648051b59c FDA-1976-N-0027-0086,FDA,FDA-1976-N-0027,"TAB 2 Citizen Petition from Thompson Medical Company, Inc. re Ephedrine and Norephedrine",Supporting & Related Material,Background Material,2008-10-14T04:00:00Z,2008,10,,,2015-12-23T15:14:53Z,,0,0,090000648051b5ab FDA-1976-N-0027-0122,FDA,FDA-1976-N-0027,"Background Material (04NFMA3) - mo from Director, Division of OTC Drug Products, CDER to Robert J. Wolters, Ph.D., Chemist, Division of Cario-Renal Drug Products",Supporting & Related Material,BKG-Background Material,2008-10-14T04:00:00Z,2008,10,,,2015-11-10T16:32:22Z,,0,0,090000648051b68f FDA-1976-N-0027-0076,FDA,FDA-1976-N-0027,Letter from FDA/CBER - HFN-210 to Menley & James Laboratories,Other,Letter(s),2008-10-14T04:00:00Z,2008,10,2008-10-14T04:00:00Z,,2015-12-30T16:38:27Z,,0,0,090000648051b599 FDA-1976-N-0027-0108,FDA,FDA-1976-N-0027,"Citzen Petition from Thompson Medical Company, Inc. - CP9 - re Appendix I - Analysis of Variance, Means, and Standard Deviations for Blood Pressure and Pulse Variables",Supporting & Related Material,Citizen Petition,2008-10-14T04:00:00Z,2008,10,,,2015-12-22T19:00:30Z,,0,0,090000648051b5eb FDA-1976-N-0027-0093,FDA,FDA-1976-N-0027,Letter from FDA/CDER - HFN-210 to Thompson Medical Company,Other,Letter(s),2008-10-14T04:00:00Z,2008,10,2008-10-14T04:00:00Z,,2015-11-03T19:22:48Z,,0,0,090000648051b5c1 FDA-1976-N-0027-0118,FDA,FDA-1976-N-0027,FDA/CDER,Supporting & Related Material,LET-Letter (Supporting and Related Material),2008-10-14T04:00:00Z,2008,10,,,2008-10-14T21:02:51Z,,0,0,090000648051b687 FDA-1976-N-0027-0114,FDA,FDA-1976-N-0027,"Letter from FDA/CDER - HFD-810 to Caprice-Greystoke, Ltd.",Other,Letter(s),2008-10-14T04:00:00Z,2008,10,2008-10-14T04:00:00Z,,2015-11-02T19:28:13Z,,0,0,090000648051b682 FDA-1976-N-0027-0121,FDA,FDA-1976-N-0027,"Background Material (04NFMA3) - References, Sixth Supplement, USP-NF",Supporting & Related Material,BKG-Background Material,2008-10-14T04:00:00Z,2008,10,,,2008-10-14T21:02:54Z,,0,0,090000648051b68e FDA-1976-N-0027-0083,FDA,FDA-1976-N-0027,"Tab 10 Unidentified Nixon, Hargrave, Devans, & Doyle submission to 81N-0022 dated January 6, 1983 re Citizen Petition from Thompson Medical Company, Inc.",Other,Citizen Petition,2008-10-14T04:00:00Z,2008,10,2008-10-14T04:00:00Z,,2015-12-22T14:45:30Z,,0,0,090000648051b5a8 FDA-1976-N-0027-0090,FDA,FDA-1976-N-0027,Letter from FDA/CDER - HFN-210 to Thompson Medical Company,Other,Letter(s),2008-10-14T04:00:00Z,2008,10,2008-10-14T04:00:00Z,,2015-11-03T20:20:39Z,,0,0,090000648051b5b3 FDA-1976-N-0027-0079,FDA,FDA-1976-N-0027,"Tab 16 Letter from Jonathan O. Cole, M.D. to Dr. Edward Steinberg dated April 9, 1984 - CP7 re Citizen Petition from Thompson Medical Company, Inc.",Supporting & Related Material,Background Material,2008-10-14T04:00:00Z,2008,10,,,2015-12-23T17:00:46Z,,0,0,090000648051b59e FDA-1976-N-0027-0081,FDA,FDA-1976-N-0027,"Tab 12 81N-0022, Vol 5, CP 5 without attachments re Citizen Petition from Thompson Medical Company, Inc.",Supporting & Related Material,Background Material,2008-10-14T04:00:00Z,2008,10,,,2015-12-23T16:52:52Z,,0,0,090000648051b5a6 FDA-1976-N-0027-0115,FDA,FDA-1976-N-0027,"Petition Approval from FDA/Office of the Commissioner to Thompson Medical Company, Inc.",Other,Approval,2008-10-14T04:00:00Z,2008,10,2008-10-14T04:00:00Z,,2015-11-10T20:39:23Z,,0,0,090000648051b68a FDA-1976-N-0027-0120,FDA,FDA-1976-N-0027,"Background Material (04NFMA3) - Electronic mail response by Wolters, Ph.D., to above memo",Supporting & Related Material,BKG-Background Material,2008-10-14T04:00:00Z,2008,10,,,2008-10-14T21:02:53Z,,0,0,090000648051b68d FDA-1976-N-0027-0105,FDA,FDA-1976-N-0027,"Citizen Petition from Thompson Medical Company, Inc. re Appendix III - Supplemental Analysis of Individual Effects-CP9",Supporting & Related Material,Citizen Petition,2008-10-14T04:00:00Z,2008,10,,,2015-12-22T18:40:15Z,,0,0,090000648051b5e8 FDA-1976-N-0027-0080,FDA,FDA-1976-N-0027,Tab 14 Final Report A Multisite Evaluation of the Acute Effects of Phenylpropanolamine in Normal Volunteers George L Blackburn M D Ph D July 24 1984 CP7 re Citizen Petition from Thompson Medical Company Inc,Supporting & Related Material,Background Material,2008-10-14T04:00:00Z,2008,10,,,2015-12-23T16:57:04Z,,0,0,090000648051b5a4 FDA-1976-N-0027-0094,FDA,FDA-1976-N-0027,"Minutes of Meeting February 25, 1985 between FDA/CDER and Industry/Press",Other,Memorandum,2008-10-14T04:00:00Z,2008,10,2008-10-14T04:00:00Z,,2015-11-04T17:34:58Z,,0,0,090000648051b5c4