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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, null, null, "2015-12-18T14:58:46Z", null, 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, null, null, "2015-12-09T19:01:38Z", null, 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, null, null, "2015-12-15T18:55:56Z", null, 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, null, null, "2015-12-18T16:39:40Z", null, 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, null, null, "2015-12-18T16:57:34Z", null, 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", null, "2015-11-09T21:39:26Z", null, 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, null, null, "2015-12-15T18:51:26Z", null, 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, null, null, "2015-12-18T16:51:29Z", null, 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", null, "2015-11-25T16:36:14Z", null, 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, null, null, "2015-12-15T17:15:33Z", null, 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. 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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, null, null, "2015-12-15T18:53:43Z", null, 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, null, null, "2015-12-18T16:31:51Z", null, 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, null, null, "2015-12-15T17:07:47Z", null, 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", null, "2015-11-25T16:08:54Z", null, 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", null, "2015-12-14T16:51:24Z", null, 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", null, "2015-11-25T16:13:18Z", null, 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", null, "2015-11-09T16:49:59Z", null, 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", null, "2015-11-10T19:19:10Z", null, 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", null, "2015-11-25T16:17:47Z", null, 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, null, null, "2015-12-18T16:48:03Z", null, 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, null, null, "2015-12-18T17:01:51Z", null, 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", null, "2015-11-25T16:53:21Z", null, 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", null, "2015-11-09T21:30:29Z", null, 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", null, "2015-11-25T16:21:22Z", null, 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, null, null, "2015-12-15T17:23:49Z", null, 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, null, null, "2015-12-18T16:55:03Z", null, 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", null, "2015-11-25T16:28:02Z", null, 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, null, null, "2015-12-30T15:13:54Z", null, 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", null, "2015-11-10T15:00:00Z", null, 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. 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