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withdrawn,object_id FDA-1976-N-0031-0259,FDA,FDA-1976-N-0031,Transcript from NDAC-PADAC 16 NOV 1995,Other,Transcript(s),2018-10-30T04:00:00Z,2018,10,2018-10-30T04:00:00Z,,2018-10-30T11:33:50Z,,0,0,0900006483867e81 FDA-1976-N-0031-0260,FDA,FDA-1976-N-0031,Minutes from NDAC-PAC 18-19 OCT 2007,Other,Minutes,2018-10-30T04:00:00Z,2018,10,2018-10-30T04:00:00Z,,2018-10-30T11:34:54Z,,0,0,0900006483867e82 FDA-1976-N-0031-0223,FDA,FDA-1976-N-0031,Letter from Florida Pharmacy Association,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:02:34Z,,0,0,090000648051bb7c FDA-1976-N-0031-0211,FDA,FDA-1976-N-0031,"Exhibit 5 re Letter from Warner-Lambert Company - Allergy & Asthma Clinic, P.C. to Warner-Chilcott dated February 15, 1977",Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:44:32Z,,0,0,090000648051bb68 FDA-1976-N-0031-0226,FDA,FDA-1976-N-0031,Amendment from Vick's Division of Research and Development re Supplement 11 from Vick's Division of Research and Development on 06/07/1979,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:03:31Z,,0,0,090000648051bb80 FDA-1976-N-0031-0246,FDA,FDA-1976-N-0031,Supporting material re Amendment from Smith Kline & French Laboratories (REDACTED),Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T19:24:31Z,,0,0,09000064822aefbf FDA-1976-N-0031-0130,FDA,FDA-1976-N-0031,"Final Order, Opinion of the Commission, and Initial Decision by Federal Trade Commission in the Matter of Warner-Lambert Company",Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T17:42:25Z,,0,0,090000648228ec92 FDA-1976-N-0031-0256,FDA,FDA-1976-N-0031,"Acknowledgment Letter from FDA/CDER to Clifford, Glass, McTwain & Tinney",Other,Acknowledgement Letter/Receipt,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T20:05:30Z,,0,0,0900006481ce5694 FDA-1976-N-0031-0238,FDA,FDA-1976-N-0031,Letter from FDA/HFD-513 to Pfizer Pharmaceuticals,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:20:55Z,,0,0,090000648051bb8e FDA-1976-N-0031-0131,FDA,FDA-1976-N-0031,Official Transcript of Proceedings Before the Federal Trade Commission (1 of 2),Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T17:42:34Z,,0,0,090000648228ec93 FDA-1976-N-0031-0227,FDA,FDA-1976-N-0031,Answer from FDA re Amendment from Vick's Division of Research and Development re Supplement 11 from Vick's Division of Research and Development on 06/07/1979,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:03:40Z,,0,0,09000064822abbb2 FDA-1976-N-0031-0178,FDA,FDA-1976-N-0031,Section III: Description of the D.A.T.A. System,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T18:17:52Z,,0,0,090000648229b47c FDA-1976-N-0031-0215,FDA,FDA-1976-N-0031,Letter from Vick Divisions Research and Development (Richardson-Merrell Inc.),Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:52:34Z,,0,0,090000648051bb71 FDA-1976-N-0031-0146,FDA,FDA-1976-N-0031,Request for Extension Comment from The Proprietary Association,Other,Request for Extension,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T17:52:05Z,,0,0,090000648051bb1e FDA-1976-N-0031-0220,FDA,FDA-1976-N-0031,Letter from Vick Divisions Research and Development (Richardson-Merrell Inc.),Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:59:29Z,,0,0,090000648051bb76 FDA-1976-N-0031-0206,FDA,FDA-1976-N-0031,"Supplement from Smith Kline Corporation (Vol. 1 of 6) re Data Supporting the Efficacy of Chlorpheniramine Maleate in Providing Symptomatic Relief of the ''Common Cold""",Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:35:27Z,,0,0,090000648051bb59 FDA-1976-N-0031-0062,FDA,FDA-1976-N-0031,Memorandum of Telephone Conversation from FDA/CDER,Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T14:58:19Z,,0,0,090000648051babe FDA-1976-N-0031-0171,FDA,FDA-1976-N-0031,Letter from Fisons Corporation to FDA/CDER,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:16:05Z,,0,0,090000648051bb3a FDA-1976-N-0031-0244,FDA,FDA-1976-N-0031,"Memorandum of Meeting Between FDA/CDER, Burroughs-Wellcome Co., Dow Chemical Co. and Schering Corp.",Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:24:06Z,,0,0,090000648051bb98 FDA-1976-N-0031-0194,FDA,FDA-1976-N-0031,Answer from FDA/CDER to American Pharmaceutical Association,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:28:02Z,,0,0,090000648051bbc8 FDA-1976-N-0031-0170,FDA,FDA-1976-N-0031,Correction of Comment from The Proprietary Association,Other,Correction(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:15:53Z,,0,0,090000648051bb39 FDA-1976-N-0031-0207,FDA,FDA-1976-N-0031,Supplement from Smith Kline & French Laboratories,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:36:09Z,,0,0,090000648051bb5a FDA-1976-N-0031-0159,FDA,FDA-1976-N-0031,"Correction from Miles Laboratories, Inc",Other,Correction(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T17:55:45Z,,0,0,090000648051bb2b FDA-1976-N-0031-0091,FDA,FDA-1976-N-0031,Notice of Decision on Diphenhydramine As An Antitussive,Notice,General Notice,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T15:19:55Z,,0,0,0900006481cfac60 FDA-1976-N-0031-0147,FDA,FDA-1976-N-0031,Answer from FDA/CDER re Request for Extension Comment from The Proprietary Association,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2017-11-29T07:09:41Z,,0,0,090000648227cf04 FDA-1976-N-0031-0109,FDA,FDA-1976-N-0031,"Table of Contents re Comment from Vick Divisions Research, Vick Chemical Company",Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T15:48:36Z,,0,0,0900006482278091 FDA-1976-N-0031-0113,FDA,FDA-1976-N-0031,"List of Attachments re Comment from Vick Divisions Research, Vick Chemical Company",Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T16:31:40Z,,0,0,0900006482278751 FDA-1976-N-0031-0175,FDA,FDA-1976-N-0031,"Supporting material re Supplement from Graduate Research Laboratories, Inc. - Table of Contents",Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T18:17:35Z,,0,0,090000648229b479 FDA-1976-N-0031-0177,FDA,FDA-1976-N-0031,Section II: Automated Antitussive Instruments -- A Literature Review,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T18:17:47Z,,0,0,090000648229b47b FDA-1976-N-0031-0225,FDA,FDA-1976-N-0031,Letter from Warner-Lambert Company to FDA,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:03:00Z,,0,0,090000648051bb7e FDA-1976-N-0031-0232,FDA,FDA-1976-N-0031,Answer from FDA/CDER to Warner-Lambert Company,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:05:31Z,,0,0,0900006480f1773d FDA-1976-N-0031-0140,FDA,FDA-1976-N-0031,"Request for Extension from Graduate Research Laboratories, Inc.",Other,Request for Extension,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T17:50:01Z,,0,0,090000648051bb18 FDA-1976-N-0031-0166,FDA,FDA-1976-N-0031,Over-The Counter-Drugs: Notice of Decision on Theophylline as a Single Ingredient,Notice,General Notice,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:05:24Z,,0,0,090000648051bb35 FDA-1976-N-0031-0210,FDA,FDA-1976-N-0031,Letter from Warner-Lambert Company,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:44:15Z,,0,0,090000648051bb69 FDA-1976-N-0031-0224,FDA,FDA-1976-N-0031,Memorandum of Telephone Conversation Between FDA/CDER and Warner Lambert,Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:02:47Z,,0,0,090000648051bb7d FDA-1976-N-0031-0242,FDA,FDA-1976-N-0031,Letter from National Pharmaceutical Mfg. Co. to FDA/CDER,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:23:36Z,,0,0,090000648051bb95 FDA-1976-N-0031-0169,FDA,FDA-1976-N-0031,Answer re Request for Extension from Graduate Research Laboratories Inc.,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:15:43Z,,0,0,09000064822948e4 FDA-1976-N-0031-0222,FDA,FDA-1976-N-0031,Letter from Bristol-Myers Products (A Division of Bristol-Myers Company) to FDA,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:02:19Z,,0,0,090000648051bb7a FDA-1976-N-0031-0254,FDA,FDA-1976-N-0031,Letter from FDA/CDER to The Dow Chemical Company,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:32:56Z,,0,0,090000648051bba4 FDA-1976-N-0031-0205,FDA,FDA-1976-N-0031,Supplement from Schering Corporation,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:34:22Z,,0,0,090000648051bb58 FDA-1976-N-0031-0213,FDA,FDA-1976-N-0031,Supplement from Vick's Division of Research and Development,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:51:58Z,,0,0,090000648051bb6f FDA-1976-N-0031-0245,FDA,FDA-1976-N-0031,Amendment from Smith Kline & French Laboratories,Other,Amendment,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:24:19Z,,0,0,090000648051bb99 FDA-1976-N-0031-0255,FDA,FDA-1976-N-0031,Letter from FDA/CDER to Schering-Plough Corporation,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:33:07Z,,0,0,090000648051bba5 FDA-1976-N-0031-0176,FDA,FDA-1976-N-0031,Section I: Overview,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T18:17:41Z,,0,0,090000648229b47a FDA-1976-N-0031-0221,FDA,FDA-1976-N-0031,Letter from Vick Divisions Research and Development (Richardson-Merrell Inc.),Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:59:53Z,,0,0,090000648051bb77 FDA-1976-N-0031-0064,FDA,FDA-1976-N-0031,Request for Extension from Richardson-Merrell Inc.,Other,Request for Extension,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T14:58:49Z,,0,0,090000648051bac0 FDA-1976-N-0031-0029,FDA,FDA-1976-N-0031,"Memorandum of Telephone Conversation Between Tenny P. Neprud, Compliance Regulations Policy Staff, ACC and Harold F. O' Keefe, Arthur A. Checchi, Inc.",Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T13:16:21Z,,0,0,090000648051ba67 FDA-1976-N-0031-0195,FDA,FDA-1976-N-0031,"Over-The-Counter Drugs Proposed Monograph for OTC Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products; Amendment",Notice,General Notice,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,1977-12-28T04:59:59Z,2016-10-14T18:28:17Z,,0,0,090000648051bb4e FDA-1976-N-0031-0132,FDA,FDA-1976-N-0031,Official Transcript of Proceedings Before the Federal Trade Commission (2 of 2),Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T17:42:41Z,,0,0,090000648228ec94 FDA-1976-N-0031-0097,FDA,FDA-1976-N-0031,"Supporting material re Comment from Joint Council of Socio-Economics of Allergy - Position Statement on Over-The-Counter Sales of Antihistamine and Decongestant Drugs, by Joint Council of Socio-Economics of Allergy Committee to the FDA",Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T15:21:09Z,,0,0,090000648227f4e4 FDA-1976-N-0031-0107,FDA,FDA-1976-N-0031,Tab 1: Cold Symptoms Grouped as to Responsiveness to Three Categories of Pharmacological Activity,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T15:33:23Z,,0,0,090000648227fb1f FDA-1976-N-0031-0106,FDA,FDA-1976-N-0031,Exhibit 1: Supporting material re Comment from Dorsey Laboratories,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T15:33:17Z,,0,0,090000648227fb1e FDA-1976-N-0031-0257,FDA,FDA-1976-N-0031,Correction from Vick Divisions Research and Development,Other,Correction(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T20:06:16Z,,0,0,0900006481ce2563 FDA-1976-N-0031-0219,FDA,FDA-1976-N-0031,Supplement from Vick Divisions Research and Development,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:58:51Z,,0,0,09000064822a38b6 FDA-1976-N-0031-0204,FDA,FDA-1976-N-0031,Answer from FDA/CDER re Comment from Bristol-Myers Products,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:32:55Z,,0,0,090000648228fb80 FDA-1976-N-0031-0189,FDA,FDA-1976-N-0031,Supporting material re Reply Comment from Merrell-National Laboratories - 2/9/77 letter to Dr. Parks,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T18:23:13Z,,0,0,090000648229351b FDA-1976-N-0031-0037,FDA,FDA-1976-N-0031,"Memorandum of Meeting between FDA/CDER and representatives of Parke, Davis and Company",Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T13:39:05Z,,0,0,090000648051ba9f FDA-1976-N-0031-0202,FDA,FDA-1976-N-0031,Petition for Reconsideration from Parke-Davis & Company,Other,Petition for Reconsideration,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:30:14Z,,0,0,090000648051bb56 FDA-1976-N-0031-0126,FDA,FDA-1976-N-0031,Supplement from Ohio Society of Allergy and Immunology,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T17:37:38Z,,0,0,090000648051bb0d FDA-1976-N-0031-0193,FDA,FDA-1976-N-0031,Answer from FDA/CDER to Freida Rasmussen,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:27:50Z,,0,0,090000648051bbc9 FDA-1976-N-0031-0110,FDA,FDA-1976-N-0031,"Comment from Vick Divisions Research, Vick Chemical Company (Vol. 2 of 8)",Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T16:08:43Z,,0,0,0900006481cdcc41 FDA-1976-N-0031-0253,FDA,FDA-1976-N-0031,Letter from FDA/CDER to Burroughs Wellcome Company,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:32:45Z,,0,0,090000648051bba3 FDA-1976-N-0031-0168,FDA,FDA-1976-N-0031,Request for Extension from Graduate Research Laboratories Inc.,Other,Request for Extension,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:15:36Z,,0,0,090000648051bb38 FDA-1976-N-0031-0076,FDA,FDA-1976-N-0031,Tab 2: Composition,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T15:10:47Z,,0,0,090000648051bad3 FDA-1976-N-0031-0239,FDA,FDA-1976-N-0031,Memorandum from FDA/HFD-510 to FDA/HFA-305,Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:22:20Z,,0,0,090000648051bbc0 FDA-1976-N-0031-0237,FDA,FDA-1976-N-0031,Memorandum from FDA/HFD-510 to FDA/HFA-305,Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:07:28Z,,0,0,090000648051bb8d FDA-1976-N-0031-0077,FDA,FDA-1976-N-0031,Tab 6: Summary,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T15:11:08Z,,0,0,090000648051bace FDA-1976-N-0031-0111,FDA,FDA-1976-N-0031,"Background Material re Comment from Vick Divisions Research, Vick Chemical Company (Vol. 6 of 8)",Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T16:23:44Z,,0,0,0900006481cdd5b0 FDA-1976-N-0031-0179,FDA,FDA-1976-N-0031,Section IV: Validation of the D.A.T.A. System,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T18:17:59Z,,0,0,090000648229b47d FDA-1976-N-0031-0235,FDA,FDA-1976-N-0031,Supporting material re Comment from Bristol-Myers - Investigator Letters,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T19:07:04Z,,0,0,09000064822adc34 FDA-1976-N-0031-0214,FDA,FDA-1976-N-0031,Answer from FDA re Supplement from Vick's Division of Research and Development,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:52:11Z,,0,0,09000064822a0d57 FDA-1976-N-0031-0218,FDA,FDA-1976-N-0031,Supplement from Vick Divisions Research and Development,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:54:04Z,,0,0,0900006481cdeec9 FDA-1976-N-0031-0251,FDA,FDA-1976-N-0031,"Petition Approval from FDA/CDER to Marion Laboratories, Inc.",Other,Approval,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:26:03Z,,0,0,090000648051bba1 FDA-1976-N-0031-0230,FDA,FDA-1976-N-0031,Supplement from A. H. Robins Company,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:04:22Z,,0,0,090000648051bb85 FDA-1976-N-0031-0243,FDA,FDA-1976-N-0031,Petition for Stay of Action from Dow Chemical U. S. A.,Other,Petition for Reconsideration,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:23:50Z,,0,0,090000648051bb97 FDA-1976-N-0031-0174,FDA,FDA-1976-N-0031,"Supplement from Graduate Research Laboratories, Inc.",Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:17:16Z,,0,0,090000648051bb3f FDA-1976-N-0031-0252,FDA,FDA-1976-N-0031,Petition Approval from FDA/CDER to Johnson and Johnson,Other,Approval,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:29:57Z,,0,0,090000648051bba2 FDA-1976-N-0031-0197,FDA,FDA-1976-N-0031,Supplement from Massachusetts College of Pharmacy,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:28:48Z,,0,0,090000648051bb50 FDA-1976-N-0031-0063,FDA,FDA-1976-N-0031,Request for Extension from The Proprietary Association,Other,Request for Extension,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T14:58:39Z,,0,0,090000648051babf FDA-1976-N-0031-0112,FDA,FDA-1976-N-0031,"Background Material re Comment from Vick Divisions Research, Vick Chemical Company (Vol. 8 of 8)",Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T16:30:42Z,,0,0,0900006482278096 FDA-1976-N-0031-0241,FDA,FDA-1976-N-0031,"Petition for Stay of Action from Marion Laboratories, Inc.",Other,Petition for Reconsideration,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:23:05Z,,0,0,090000648051bb93 FDA-1976-N-0031-0229,FDA,FDA-1976-N-0031,Answer from FDA re Supplement from A. H. Robins Company,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:04:00Z,,0,0,09000064822ac9da FDA-1976-N-0031-0075,FDA,FDA-1976-N-0031,Tab 1a: Current Labels/Labeling,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T15:10:32Z,,0,0,090000648051bad5 FDA-1976-N-0031-0190,FDA,FDA-1976-N-0031,Supporting material re Reply Comment from Merrell-National Laboratories - Doxylamine Succinate Bibliography,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T18:23:25Z,,0,0,090000648229351d FDA-1976-N-0031-0217,FDA,FDA-1976-N-0031,Memorandum of Telephone Conversation Between FDA/CDER and Warner-Lambert Company,Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T18:53:31Z,,0,0,090000648051bb73 FDA-1976-N-0031-0240,FDA,FDA-1976-N-0031,Petition for Reconsideration from Johnson and Johnson,Other,Petition for Reconsideration,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:22:52Z,,0,0,090000648051bb91 FDA-1976-N-0031-0228,FDA,FDA-1976-N-0031,Supplement from A. H. Robins Company,Other,Supplement (SUP),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:03:52Z,,0,0,090000648051bb81 FDA-1976-N-0031-0163,FDA,FDA-1976-N-0031,Letter from Louisiana State University Medical Center to FDA/CDER,Other,Letter(s),2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T17:58:44Z,,0,0,090000648051bb32 FDA-1976-N-0031-0030,FDA,FDA-1976-N-0031,"Reference from U. S. Department of Health , Education and Welfare",Supporting & Related Material,Reference (internal unless indicated),2016-10-14T04:00:00Z,2016,10,,,2016-10-14T13:16:40Z,,0,0,090000648051ba9c FDA-1976-N-0031-0114,FDA,FDA-1976-N-0031,Answer from FDA/CDER (formerly Bureau of Drugs) to Vick Divisions Research and Development,Other,Answer,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T16:34:39Z,,0,0,0900006480a77ae8 FDA-1976-N-0031-0248,FDA,FDA-1976-N-0031,Memorandum of Telephone Conversation Between FDA/CDER and Johnson & Johnson,Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T19:25:12Z,,0,0,090000648051bb9d FDA-1976-N-0031-0061,FDA,FDA-1976-N-0031,Memorandum of Telephone Conversation from FDA/CDER,Other,Memorandum,2016-10-14T04:00:00Z,2016,10,2016-10-14T04:00:00Z,,2016-10-14T14:56:37Z,,0,0,090000648051babd FDA-1976-N-0031-0258,FDA,FDA-1976-N-0031,Background material re Administrative File for the Statement of The Advisory Review Panel on OTC Miscellaneous External Drug Products Concerning OTC Drugs Containing Campher,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T20:09:14Z,,0,0,09000064822ae4cd FDA-1976-N-0031-0236,FDA,FDA-1976-N-0031,Supporting material re Comment from Bristol-Myers - Statistical Report,Supporting & Related Material,Background Material,2016-10-14T04:00:00Z,2016,10,,,2016-10-14T19:07:11Z,,0,0,09000064822adc35 FDA-1976-N-0031-0027,FDA,FDA-1976-N-0031,"Notice of Proposed Rule re Over-The-Counter Drugs; Establishment of a Monograph for OTC Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products (Page 324 -423)
",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-09-26T04:00:00Z,2016,9,2016-09-26T04:00:00Z,1976-12-09T04:59:59Z,2016-09-26T18:16:23Z,,0,0,0900006481e508da FDA-1976-N-0031-0028,FDA,FDA-1976-N-0031,"Notice of Proposed Rule re Over-The-Counter Drugs; Establishment of a Monograph for OTC Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Products (Part 926-940)
",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-09-26T04:00:00Z,2016,9,2016-09-26T04:00:00Z,1976-12-09T04:59:59Z,2016-09-26T18:26:14Z,,0,0,0900006481e4f035 FDA-1976-N-0031-0023,FDA,FDA-1976-N-0031,Memorandum of Telephone Conversation between FDA/CDER and Schering Laboratories Medical Research,Other,Memorandum,2012-03-14T04:00:00Z,2012,3,2012-03-14T04:00:00Z,,2015-10-13T17:48:27Z,,0,0,090000648051bb5b FDA-1976-N-0031-0025,FDA,FDA-1976-N-0031,Supplement from Richardson-Merrell Inc. (Vick Divisions Research and Development),Other,Supplement (SUP),2012-03-14T04:00:00Z,2012,3,2012-03-14T04:00:00Z,,2016-10-06T14:59:23Z,,0,0,090000648051bb6e FDA-1976-N-0031-0024,FDA,FDA-1976-N-0031,"Notice on Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products For Over-The-Counter (OTC) Human Use; Decision On Dosage Of Pseudoephedrine Preparations",Notice,General Notice,2012-03-14T04:00:00Z,2012,3,2012-03-14T04:00:00Z,,2016-01-21T15:28:44Z,,0,0,090000648051bb90 FDA-1976-N-0031-0026,FDA,FDA-1976-N-0031,Memorandum of Telephone Conversation between FDA/CDER and Vick Devisions Research & Development,Other,Memorandum,2012-03-14T04:00:00Z,2012,3,2012-03-14T04:00:00Z,,2016-10-05T14:42:39Z,,0,0,090000648051bb89