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97 rows where docket_id = "FDA-1982-N-0005" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1982-N-0005-0022 FDA OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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 OTC Drug Products for Overindulgence of Alcohol 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

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