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withdrawn,object_id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-1982-N-0005-0022,FDA,FDA-1982-N-0005,"Tab II: Characteristics of the Solution Distinguishing Alka-Seltzer From Other Forms of Aspirin re Comment from Miles Laboratories, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:28:40Z,,0,0,090000648050d5ed
FDA-1982-N-0005-0026,FDA,FDA-1982-N-0005,Tab VI: Evidence For Aspirin-Insensitive Mechanisms Capable of Effecting Normal Platelet Function,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:29:21Z,,0,0,090000648050d5f5
FDA-1982-N-0005-0038,FDA,FDA-1982-N-0005,Attachment 1: Introduction & Background re Comment from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:11:01Z,,0,0,090000648050d69b
FDA-1982-N-0005-0050,FDA,FDA-1982-N-0005,"Reference 11: Lukacovic M.F., Walters K.J., Dog bioavailability study with Pentagastrin - Pepto-Bismol with simethicone. PBDB # 14. Procter & Gamble. (1992)",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:19:01Z,,0,0,090000648050d6f2
FDA-1982-N-0005-0064,FDA,FDA-1982-N-0005,Appendix F re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:37Z,,0,0,090000648050d714
FDA-1982-N-0005-0053,FDA,FDA-1982-N-0005,Supplement from Procter and Gamble Company,Other,Supplement (SUP),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:20:21Z,,0,0,090000648050d6f8
FDA-1982-N-0005-0077,FDA,FDA-1982-N-0005,"Attachment 4. ""Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post Surgical Dental Pain"" (List of Table of Contents) re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:32:47Z,,0,0,090000648050d725
FDA-1982-N-0005-0085,FDA,FDA-1982-N-0005,"""A Double-Blind, Single Dose Evaluation of the Relative Analgesic Efficacy and Adverse Effect Liability of Effervescent Aspirin, Non-Effervescent Aspirin and Placebo in the Treatment of Postoperative Pain Following Oral Surgery."" (III. Protocol) re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:33:42Z,,0,0,090000648050d741
FDA-1982-N-0005-0106,FDA,FDA-1982-N-0005,"Attachment 1: Yip et al ., Chemical Equilibrium of Alka-Seltzer Solution and the Gas Formation Rate when Mixed with a Simulated Gastric Fluid",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:41:28Z,,0,0,090000648050d78c
FDA-1982-N-0005-0027,FDA,FDA-1982-N-0005,Tab VII: Evidence Against Assessing Any Role For Aspirin-Induced Platelet Dysfunction in Gastrointestinal Bleeding,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:29:31Z,,0,0,090000648050d5f7
FDA-1982-N-0005-0035,FDA,FDA-1982-N-0005,"Background Material re Public Administrative File for the OTC Orally
Administered Products for Relief of Symptoms Associated
with Overindulgence in Food and Drink Rulemaking; Docket
No. 82N-0166",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:40:45Z,,0,0,090000648050d681
FDA-1982-N-0005-0048,FDA,FDA-1982-N-0005,"Attachment 4: Aspirin, Paracetamol, and Haematemesis and Melaena by D. Coggon, M.J.S. Langman, and D. Spiegelhalter re Comment from Miles Laboratories, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:14:53Z,,0,0,090000648050d6d8
FDA-1982-N-0005-0060,FDA,FDA-1982-N-0005,Table of Contents for Appendices re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:20Z,,0,0,090000648050d70d
FDA-1982-N-0005-0065,FDA,FDA-1982-N-0005,Appendix G re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:42Z,,0,0,090000648050d716
FDA-1982-N-0005-0072,FDA,FDA-1982-N-0005,"Attachment 3. Effectiveness Data on the Solution (III) re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:25:23Z,,0,0,090000648050d720
FDA-1982-N-0005-0017,FDA,FDA-1982-N-0005,"""Alcohol Involvement in Traffic Accidents: Recent Estimates from the National Center for Statistics and Analysis"" ( NHTSA Technical Report, DOT HS-806-269, May 1982) re Memorandum from FDA (HFN 510) to Dockets Management Branch (HFA-305)",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:22:56Z,,0,0,090000648206f0eb
FDA-1982-N-0005-0088,FDA,FDA-1982-N-0005,Clinical Protocol : Comparison of Emetrol Versus Placebo in Treating Upset Stomach in Children - 105008-999 -  re Protocol Review from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:34:26Z,,0,0,090000648050d749
FDA-1982-N-0005-0089,FDA,FDA-1982-N-0005,Final Report: Comparison of Emetrol Versus Placebo In Treating Upset Stomach In Children re Protocol Review from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:34:30Z,,0,0,090000648050d74a
FDA-1982-N-0005-0094,FDA,FDA-1982-N-0005,Tab E: Introduction to the Report By Reye’s Syndrome Working Group to the FDA. 1982,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:36:06Z,,0,0,090000648050d767
FDA-1982-N-0005-0118,FDA,FDA-1982-N-0005,"Reference 3: Lukacovic, M.F. and K.J. Watters, ""Dog Bioavailability Study with Pentagastrin - Pepto-Bismol with Simethicone, PBDB#14,"" The Procter & Gamble Co., in C12, 1992.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:44:48Z,,0,0,090000648050d7c9
FDA-1982-N-0005-0114,FDA,FDA-1982-N-0005,Letter from Procter and Gamble Company to FDA/CDER,Other,Letter(s),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:43:58Z,,0,0,090000648050d7c2
FDA-1982-N-0005-0081,FDA,FDA-1982-N-0005,"""Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post Surgical Dental Pain"" (IV. Protocol) re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:33:11Z,,0,0,090000648050d729
FDA-1982-N-0005-0083,FDA,FDA-1982-N-0005,"""A Double-Blind, Single Dose Evaluation of the Relative Analgesic Efficacy and Adverse Effect Liability of Effervescent Aspirin, Non-Effervescent Aspirin and Placebo in the Treatment of Postoperative Pain Following Oral Surgery."" (I. Study Synopsis) re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:33:26Z,,0,0,090000648050d73c
FDA-1982-N-0005-0020,FDA,FDA-1982-N-0005,"Appendix A: Safety of Alka-Seltzer From Gastric Damage or From Gastrointestinal or Other Bleeding re Comment from Miles Laboratories, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:28:20Z,,0,0,090000648050d5e9
FDA-1982-N-0005-0029,FDA,FDA-1982-N-0005,"References re Comment from Miles Laboratories, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:29:53Z,,0,0,090000648050d5fb
FDA-1982-N-0005-0058,FDA,FDA-1982-N-0005,Appendix A re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:09Z,,0,0,090000648050d705
FDA-1982-N-0005-0070,FDA,FDA-1982-N-0005,"Attachment 1:  Ingredients and Their Characteristics (II) re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:25:10Z,,0,0,090000648050d71e
FDA-1982-N-0005-0078,FDA,FDA-1982-N-0005,"""Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post Surgical Dental Pain"" (I. Study Synopsis) re Request for Hearing form Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:32:54Z,,0,0,090000648050d726
FDA-1982-N-0005-0115,FDA,FDA-1982-N-0005,List of References 1-11,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:44:26Z,,0,0,090000648050d7c6
FDA-1982-N-0005-0016,FDA,FDA-1982-N-0005,Memorandum from FDA/HFN-510 to Dockets Management Branch (HFA-305) re Public Administrative File for Decision on Ingredients Intended to Minimize or Prevent Inebriation; Docket No. 82N-0166,Other,Memorandum,2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T18:22:48Z,,0,0,090000648050d5d7
FDA-1982-N-0005-0032,FDA,FDA-1982-N-0005,"Appendix A References Vol. 2 178A: Clinical Experts Reports on The Antacid Properties of Alka-Seltzer from Miles Laboratories, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:37:46Z,,0,0,090000648050d654
FDA-1982-N-0005-0052,FDA,FDA-1982-N-0005,List of References re Comment from Procter & Gamble Company,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:20:01Z,,0,0,09000064822e9e4c
FDA-1982-N-0005-0121,FDA,FDA-1982-N-0005,Legacy Docket Log 1982N-0166,Other,List (LST),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:47:22Z,,0,0,0900006481ced331
FDA-1982-N-0005-0025,FDA,FDA-1982-N-0005,Tab V: Order of Risk of Major Gastrointestinal Bleeding Low With Aspirin and Absent With Alka-Seltzer,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:29:12Z,,0,0,090000648050d5f3
FDA-1982-N-0005-0046,FDA,FDA-1982-N-0005,"Attachment 2: Safety of Alka-Seltzer from Gastric Damage or From Gastrointestinal or Other Bleeding re Comment from Miles Laboratories, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:14:42Z,,0,0,090000648050d6d4
FDA-1982-N-0005-0079,FDA,FDA-1982-N-0005,"""Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post Surgical Dental Pain"" (II. Statistical Report) re Request for Hearing form Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:33:00Z,,0,0,090000648050d727
FDA-1982-N-0005-0084,FDA,FDA-1982-N-0005,"Analgesic Effect of Effervescent Aspirin and Noneffervescent Aspirin in Postoperative Oral Surgery Pain re Request for Hearing form Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:33:35Z,,0,0,090000648050d73e
FDA-1982-N-0005-0092,FDA,FDA-1982-N-0005,Table of Contents re Comment from Procter & Gamble,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:35:24Z,,0,0,090000648050d761
FDA-1982-N-0005-0041,FDA,FDA-1982-N-0005,The Effect of Caffeine on Gastric Acid Production at Doses Recommended in the Treatment of Hangovers from Xavier University College of Louisiana,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:14:02Z,,0,0,090000648050d6c6
FDA-1982-N-0005-0047,FDA,FDA-1982-N-0005,"Attachment 3: Symptom Category re Comment from Miles Laboratories, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:14:47Z,,0,0,090000648050d6d5
FDA-1982-N-0005-0082,FDA,FDA-1982-N-0005,"Attachment 5. ""A Double-Blind, Single Dose Evaluation of the Relative Analgesic Efficacy and Adverse Effect Liability of Effervescent Aspirin, Non-Effervescent Aspirin and Placebo in the Treatment of Postoperative Pain Following Oral Surgery."" re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:33:18Z,,0,0,090000648050d72a
FDA-1982-N-0005-0107,FDA,FDA-1982-N-0005,Attachment 3: Analysis of the History of the Regulation of Alka-Seltzer in the OTC Drug Review,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:41:37Z,,0,0,090000648050d790
FDA-1982-N-0005-0013,FDA,FDA-1982-N-0005,"Supporting material re Comment from Norwich Eaton Pharmacal Company Division Morton -Norwich Products, Inc. - Final Report",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:19:57Z,,0,0,09000064822ea628
FDA-1982-N-0005-0044,FDA,FDA-1982-N-0005,"Comments on the Tentative Final Monograph for Orally Administered Drug Products for Relief of Symptoms Associated with Overindulgence in Food and Drink, and on the Proposed Amendment to the Tentative Final Monograph on Internal Analgesic, Antipyretic, and Antirheumatic Drug Products - Docket Nos. 82N-0166, 77N-0094",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:14:33Z,,0,0,090000648050d6cf
FDA-1982-N-0005-0074,FDA,FDA-1982-N-0005,"Attachment 5. ""Double-Blind, Single Dose Evaluation of the Relavite analgesic Efficacy and Adverse Effect Liability of Effervescent Aspirin, Non-Effervescent Aspirin and Placebo in the Treatment of Postoperative Pain Following Oral Surgery."" re Request for Hearing form Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:25:33Z,,0,0,090000648050d722
FDA-1982-N-0005-0098,FDA,FDA-1982-N-0005,"Tab J: Final Rule Making on Labeling for Oral and Rectal Over-the-
Counter Aspirin and Aspirin-Containing Drug Products. Federal Register June 9, 1988; 52 FR 11 I;21 633-21637.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:36:39Z,,0,0,090000648050d76d
FDA-1982-N-0005-0105,FDA,FDA-1982-N-0005,"Statement re Comment from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:41:23Z,,0,0,090000648050d78a
FDA-1982-N-0005-0117,FDA,FDA-1982-N-0005,"Reference 2: The Procter & Gamble co., "" In-vitro Foam Reducing Capacity Test: Pepto-Bismol With Simethicone,"" in C12.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:44:41Z,,0,0,090000648050d7c8
FDA-1982-N-0005-0103,FDA,FDA-1982-N-0005,Letter from FDA/CDER to Nonprescription Drug Manufacturers Association,Other,Letter(s),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:41:02Z,,0,0,090000648050d787
FDA-1982-N-0005-0024,FDA,FDA-1982-N-0005,Tab IV: Evidence For the Acid-Mediated Mechanism As the Cause of Aspirin-Induced Gastric Damage,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:29:05Z,,0,0,090000648050d5f1
FDA-1982-N-0005-0039,FDA,FDA-1982-N-0005,Attachment 2: Emetrol (Phosphorated Carbohydrate Solution),Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:13:03Z,,0,0,090000648050d69c
FDA-1982-N-0005-0057,FDA,FDA-1982-N-0005,Table of Contents for Appendices re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:05Z,,0,0,090000648050d703
FDA-1982-N-0005-0059,FDA,FDA-1982-N-0005,Appendix B re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:14Z,,0,0,090000648050d707
FDA-1982-N-0005-0014,FDA,FDA-1982-N-0005,"Request for Extension from Miles Laboratories, Inc.",Other,Request for Extension,2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T18:20:34Z,,0,0,090000648050d5d2
FDA-1982-N-0005-0055,FDA,FDA-1982-N-0005,Study Summary re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:20:55Z,,0,0,090000648050d6fe
FDA-1982-N-0005-0062,FDA,FDA-1982-N-0005,Appendix D re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:28Z,,0,0,090000648050d710
FDA-1982-N-0005-0069,FDA,FDA-1982-N-0005,"Introduction re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:24:59Z,,0,0,090000648050d71d
FDA-1982-N-0005-0023,FDA,FDA-1982-N-0005,Tab III: Evidence Demonstrating Absence of Gastric Damage With Alka-Seltzer,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:28:50Z,,0,0,090000648050d5ef
FDA-1982-N-0005-0033,FDA,FDA-1982-N-0005,"Federal Register, FDA, Department of Health and Human Services, Re:  External Analgesic Drug Products for Over-the-Counter Human Use; Tentative Final Monograph",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:37:53Z,,0,0,090000648050d656
FDA-1982-N-0005-0051,FDA,FDA-1982-N-0005,"Reference 12: Lukacovic, M.F., Watters, K.J., Rat gastric lesion study - Pepto-Bismol with simethicone. EtOH Study - ANTR # 53, Procter & Gamble. (1991)",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:19:06Z,,0,0,090000648050d6f4
FDA-1982-N-0005-0056,FDA,FDA-1982-N-0005,Final Report CS# 105005-000 re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:01Z,,0,0,090000648050d701
FDA-1982-N-0005-0113,FDA,FDA-1982-N-0005,List of References re Supplement from The Procter and Gamble Company,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:43:41Z,,0,0,090000648229b419
FDA-1982-N-0005-0095,FDA,FDA-1982-N-0005,Tab G: Review of the PHS Report of the Pilot Study by the Committee on the Reye Syndrome and Medications. National Academy of Sciences Institute of Medicine Report No. 5. December 1985.,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:36:22Z,,0,0,090000648050d76a
FDA-1982-N-0005-0086,FDA,FDA-1982-N-0005,"Protocol Review from Adria Laboratories re OTC Drug Products for Relief of Symptoms Associated with Overindulgence in Food and Drink, Tentative Final Monograph, 56 Fed. Reg. 66742 (December 24, 1991)",Other,Protocol Review,2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:34:06Z,,0,0,090000648050d742
FDA-1982-N-0005-0109,FDA,FDA-1982-N-0005,Letter from Procter and Gamble Company,Other,Letter(s),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:42:02Z,,0,0,090000648050d794
FDA-1982-N-0005-0031,FDA,FDA-1982-N-0005,"Supplement from Miles Laboratories, Inc.",Other,Supplement (SUP),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T18:37:33Z,,0,0,090000648050d652
FDA-1982-N-0005-0075,FDA,FDA-1982-N-0005,"Attachment 6. Excerpt on Alka-Seltzer Submitted to the Advisory Review Panel on Over-The-Counter Miscellaneous Internal Drug Products(VI. The Analgesics Proceeding) re Request for Hearing form Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:25:40Z,,0,0,090000648050d723
FDA-1982-N-0005-0076,FDA,FDA-1982-N-0005,"Attachment 7. Excerpt on Alka-Seltzer Submitted to the Advisory Review Panel on Over-The-Counter Miscellaneous Internal Drug Products(Appendix C Plus - List of References) re Request for Hearing form Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:25:45Z,,0,0,090000648050d724
FDA-1982-N-0005-0111,FDA,FDA-1982-N-0005,Supporting material re Comment from Procter & Gamble Company,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:42:24Z,,0,0,090000648050d79b
FDA-1982-N-0005-0116,FDA,FDA-1982-N-0005,"Reference 1: FDA, ""General Guidelines for OTC Drug Combination Products, September 1978,"" Division of Dockets Management, Docket No. 1978D-0322",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:44:34Z,,0,0,090000648050d7c7
FDA-1982-N-0005-0028,FDA,FDA-1982-N-0005,Tab VIII: Safety of Alka-Seltzer in Self-Medication,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:29:43Z,,0,0,090000648050d5f9
FDA-1982-N-0005-0066,FDA,FDA-1982-N-0005,Appendix H re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:46Z,,0,0,090000648050d718
FDA-1982-N-0005-0087,FDA,FDA-1982-N-0005,Introduction/Background: Emetrol re Protocol Review from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:34:13Z,,0,0,090000648050d745
FDA-1982-N-0005-0093,FDA,FDA-1982-N-0005,"Tab D: Advanced Notice of Proposed Rule Making on Labeling for
Salicylate-Containing Drug Products, Federal Register December 28, 1982; 47 FR 249, 57886-57901",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:36:00Z,,0,0,090000648050d766
FDA-1982-N-0005-0096,FDA,FDA-1982-N-0005,"Tab H:  Review of the PHS Continuing Study by the Committee on the
Reye Syndrome and Medications. National Academy of Sciences Institute of Medicine Report NO. 6 February 1987",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:36:28Z,,0,0,090000648050d76b
FDA-1982-N-0005-0099,FDA,FDA-1982-N-0005,"Tab V: Center for Disease Control: Reye Syndrome Surveillance - United
States 1989. MMWR February 8, 1991",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:37:25Z,,0,0,090000648050d779
FDA-1982-N-0005-0045,FDA,FDA-1982-N-0005,"Attachment 1: Comments on the Advance Notice of Proposed Rulemaking Regarding the Establishment of A Monograph for Orally Administered Drug Products for Relief of Symptoms Associated with Overindulgence in Alcohol and food for Over-the-Counter Human Use re Comment from Miles Laboratories, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:14:38Z,,0,0,090000648050d6d0
FDA-1982-N-0005-0063,FDA,FDA-1982-N-0005,Appendix E re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:33Z,,0,0,090000648050d712
FDA-1982-N-0005-0067,FDA,FDA-1982-N-0005,Appendix I re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:51Z,,0,0,090000648050d719
FDA-1982-N-0005-0071,FDA,FDA-1982-N-0005,"Attachment 2: Appendix B re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:25:15Z,,0,0,090000648050d71f
FDA-1982-N-0005-0073,FDA,FDA-1982-N-0005,"Attachment 4. ""Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post-Surgical Dental Pain"" re Request for Hearing from Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:25:28Z,,0,0,090000648050d721
FDA-1982-N-0005-0108,FDA,FDA-1982-N-0005,Memorandum of Telephone Conversation Between FDA/CDER and The Procter & Gamble Company,Other,Memorandum,2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:41:51Z,,0,0,090000648050d792
FDA-1982-N-0005-0011,FDA,FDA-1982-N-0005,"Memorandum from Chief, Gastrointestinal and Contraceptive Drug Monographs Branch (HFN - 514) To Dockets Management Branch (HFA - 305) re Comment to the Overindulgence Report",Other,Memorandum,2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T18:17:44Z,,0,0,090000648050d5ce
FDA-1982-N-0005-0080,FDA,FDA-1982-N-0005,"Pharmacokinetic Data Analysis on Post Surgical Dental Pain (III. Pharmacokinetic Report) re Request for Hearing form Miles, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:33:08Z,,0,0,090000648050d728
FDA-1982-N-0005-0097,FDA,FDA-1982-N-0005,"Tab I: Analysis of Exposure to Non-Aspirin Salicylates Among Subjects
from the Ohio Department of Health Survey and the Public Health Service Pilot Study on Reye Syndrome. Biometric Research Institute. June 13, 1986",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:36:33Z,,0,0,090000648050d76c
FDA-1982-N-0005-0119,FDA,FDA-1982-N-0005,"Reference 4: Lukacovic, M. F. and K.J. Watters, ""Rat Gastric Lesion Study-Pepto Bismol With Simethicone. EtOH Study-ANTR #53, "" The Procter & Gamble Co., in C12, 1991",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:44:57Z,,0,0,090000648050d7ca
FDA-1982-N-0005-0101,FDA,FDA-1982-N-0005,"Correction from Aspirin Foundation of America, Inc.",Other,Correction(s),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:40:40Z,,0,0,090000648050d783
FDA-1982-N-0005-0054,FDA,FDA-1982-N-0005,Supplement from Adria Laboratories,Other,Supplement (SUP),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:20:47Z,,0,0,090000648050d6fc
FDA-1982-N-0005-0102,FDA,FDA-1982-N-0005,"Letter from FDA/CDER to Cosmetic, Toiletry and Fragrance Association",Other,Letter(s),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:40:52Z,,0,0,090000648050d785
FDA-1982-N-0005-0034,FDA,FDA-1982-N-0005,Advisory Opinion Petition re Comment from PharmaControl Corporation Company,Other,Advisory Opinion Petition,2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T18:38:55Z,,0,0,090000648050d65a
FDA-1982-N-0005-0112,FDA,FDA-1982-N-0005,Supplement from The Procter and Gamble Company,Other,Supplement (SUP),2016-10-13T04:00:00Z,2016,10,2016-10-13T04:00:00Z,,2016-10-13T20:42:41Z,,0,0,090000648050d79f
FDA-1982-N-0005-0021,FDA,FDA-1982-N-0005,"Tab I: Introduction re Comment from Miles Laboratories, Inc.",Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:28:32Z,,0,0,090000648050d5eb
FDA-1982-N-0005-0030,FDA,FDA-1982-N-0005,Tab 215A: No Material Submitted,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T18:35:32Z,,0,0,090000648050d62b
FDA-1982-N-0005-0061,FDA,FDA-1982-N-0005,Appendix C re Supplement from Adria Laboratories,Supporting & Related Material,Background Material,2016-10-13T04:00:00Z,2016,10,,,2016-10-13T20:21:24Z,,0,0,090000648050d70e
FDA-1982-N-0005-0009,FDA,FDA-1982-N-0005,Notice of Proposed Rulemaking re Orally Administered Drug Products for Relief of Symptoms Associated With Overindulgence in Food and Drink for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2005-01-06T05:00:00Z,2005,1,2005-01-05T05:00:00Z,2005-04-16T03:59:59Z,2016-06-17T19:47:10Z,,0,0,090000648050d7c4
FDA-1982-N-0005-0010,FDA,FDA-1982-N-0005,Notice of Proposed Rulemaking re Orally Administered Drug Products for Relief of Symptoms Associated With Overindulgence in Food and Drink for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2005-01-06T05:00:00Z,2005,1,2005-01-05T05:00:00Z,2005-04-16T03:59:59Z,2016-06-17T19:48:27Z,,0,0,090000648050d7c5
FDA-1982-N-0005-0007,FDA,FDA-1982-N-0005,Notice of Final Rule re Lebeling for Oral and Rectal Over-the-Counter Drug Products Containing Aspirin and Nonaspirin Salicylates; Reye's Syndrome Warning,Notice,Notice of Final Rule,2003-04-22T04:00:00Z,2003,4,,,2016-10-13T18:03:59Z,,0,0,090000648050d796