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

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182 rows where agency_id = "FDA" and docket_id = "FDA-1976-N-0027" sorted by posted_date descending

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  • FDA · 182 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0027-0221 FDA OTC Nasal Decongestants FDA-1976-N-0027 Tab 64 Minutes Hemorrhagic Stroke Project Scientific Advisory Group Meeting re Comment from Novartis Consumer Health, Inc. Supporting & Related Material Background Material 2015-12-14T05:00:00Z 2015 12     2015-12-14T17:23:37Z   0 0 090000648051b831
FDA-1976-N-0027-0220 FDA OTC Nasal Decongestants FDA-1976-N-0027 Letter from FDA/CDER to Wyeth Consumer Healthcare (Arnold & Porter LLP) Other Letter(s) 2011-07-20T04:00:00Z 2011 7 2011-07-20T04:00:00Z   2015-12-15T18:29:24Z   0 0 0900006480ec7077
FDA-1976-N-0027-0219 FDA OTC Nasal Decongestants FDA-1976-N-0027 Acknowledgement Letter from FDA/CDER to McNeil Consumer Healthcare Other Acknowledgement Letter/Receipt 2009-08-13T04:00:00Z 2009 8 2009-08-13T04:00:00Z   2015-11-04T14:25:46Z   0 0 090000648051b954
FDA-1976-N-0027-0218 FDA OTC Nasal Decongestants FDA-1976-N-0027 Citizen Petition from McNeil Consumer Healthcare Other Citizen Petition 2009-08-13T04:00:00Z 2009 8 2009-08-13T04:00:00Z   2016-12-19T16:12:44Z   0 0 090000648051b953
FDA-1976-N-0027-0208 FDA OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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 OTC Nasal Decongestants 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

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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);