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

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94 rows where docket_id = "FDA-1976-N-0031" and posted_year = 2016 sorted by posted_date descending

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  • 2016 · 94 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0031-0223 FDA OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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 OTC Cold, Cough, Allergy, Bronchodilator & Antiasthmatic 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

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