美国 FDA Index of Human OTC Drug Federal Register (FR) Publications 2000~2011

Index of Human OTC Drug Federal Register (FR) Publications 2000 through 2011 Volumes 65 through 76 Division of Nonprescription Regulation Development Center for Drug Evaluation and Research Food and Drug Administration Federal Register in 2000 (Volume 65) Date FR Page Document Title Jan. 3 7 OTC Human Drugs; Labeling Requirements; Final Rule; Technical Amendment June 6 36319 Sunscreen Drug Products for OTC Human Use; Final Monograph; Extension of Effective Date; Reopening of Administrative Record; Final Rule June 20 38191 OTC Human Drugs; Labeling Requirements; Partial Extension of Compliance Dates; Final Rule June 21 38426 Ophthalmic Drug Products for OTC Human Use; Amendment of Final Monograph; Final Rule Aug. 1 46864 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Human Use; Amendment of Final Monograph for OTC Antitussive Drug Products Aug. 10 48902 Topical Otic Drug Products for OTC Human Use; Products for Drying Water- Clogged Ears; Amendment of Monograph; Lift of Partial Stay of Effective Date Aug. 25 51780 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Human Use; Reopening of the Administrative Record for Antihistamine Drug Products Aug. 29 52302 Topical Antifungal Drug Products for OTC Human Use; Amendment of Final Monograph Aug. 30 52775 Nonprescription Drugs Advisory Committee; Notice of Meeting (PPA) Aug. 30 52775 Joint Meeting of the Nonprescription Drugs Advisory Committee and the Gastrointestinal Drugs Advisory Committee; Notice of Meeting (Prilosec) Dec. 19 79371 Draft Guidance for Industry on Labeling OTC Human Drug Products -- Submitting Requests for Exemptions and Deferrals; Availability Dec. 19 79371 Guidance for Industry on Labeling OTC Human Drug Products Using a Column Format; Availability Dec. 27 81739 Correction of 21 CFR 310.545 to add paragraph (d)(2) Federal Register in 2001 (Volume 66) Date FR Page Document Title Feb. 22 11174 Draft Guidance for Industry on Labeling Over-the-Counter Human Drug Products; Updating Labeling in ANDA's; Availability May 29 29059 Topical Antifungal Drug Products for OTC Human Use: Proposed Amendment of Final Monograph June 22 33544 Request for Interest in Participating in the Selection of the Nonvoting Members of Industry Interests on Public Advisory Committees; Nonprescription Drugs Advisory Committee Aug. 14 42665 Phenylpropanolamine; Proposal to Withdraw Approval of New Drug Applications and Abbreviated New Drug Applications; Opportunity for a Hearing Sept. 27 49276 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Partial Final Rule for Combination Drug Products Containing a Bronchodilator Sept. 27 49388 Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for OTC Drug Product Labeling Oct. 15 52418 Anticaries Drug Products for Over-the-Counter Human Use; Use of Intraoral Appliance Models for compliance with Biological Testing Requirements; Request for Information and Comments Oct. 19 53088 Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Drug Products for Over- the-Counter Human Use; Partial Final Rule for Combination Drug Products Containing a Bronchodilator. Correction Dec. 31 67485 Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Partial Stay; Final Rule Federal Register in 2002 (Volume 67) Date FR Page Document Title Jan. 23 3060 Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded. Feb. 8 5942 Topical Antifungal Drug Products for Over-the-Counter Use; Amendment of Final Monograph Feb. 26 8818 Agency Information Collection Activities; Submission for OMB Review; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling Mar. 15 11571 Topical Antifungal Drug Products for Over-the-Counter Human Use; Amendment for Final Monograph; Correction Mar. 15 11704 Anticaries Drug Products for Over-the-Counter Human Use; Use of Interaoral Appliance Models for Compliance with Biological Testing Requirements; Request for Information and Comments; Reopening of Comment Period Apr. 15 16304 Over-the-Counter Drugs; Labeling Requirements; Partial Delay of Compliance Dates May 9 31123 Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients May 9 31125 Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients May 10 31739 Pediculicide Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph May 15 34720 Agency Information Collection Activities; Announcement of OMB Approval; Format and Content Requirements for Over-the-Counter (OTC) Drug Product Labeling Jun. 20 41821 Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment Aug. 21 54139 Internal analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the- Counter Human Use; Proposed Amendment of the Tentative Final Monograph, and Related Labeling Oct. 4 62218 Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use; Proposed Rule Oct. 18 64402 Guidance for Industry on Labeling Over-the-Counter Human Use; Proposed Rule Federal Register in 2002 (Volume 67) (continued) Date FR Page Document Title Dec. 6 72555 Labeling of Diphenhydramine-Containing Drug Products for Over-the-Counter Human Use Dec. 23 78158 Cold, Cough, Allergy, Bronchodilator, and Antisthmatic Drug Products for OTC Human Use; Final Monograph for Combination Drug Products Federal Register in 2003 (Volume 68) Date FR Page Document Title Jan. 16 2254 Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling Feb. 3 5299 Mercury Compounds in Drugs and Food, List Feb. 19 7919 Ophthalmic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment Feb. 19 7951 Over-the-Counter Ophthalmic Drug Products for Emergency First Aid Use; Proposed Amendment of Final Monograph for Over-the-Counter Ophthalmic Drug Products Apr. 14 17881 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use, Final Monograph for Combination Drug Products; Correction Apr. 17 18861 Labeling for Oral and Rectal Over-the-Counter Drug Products Containing Aspirin and Nonaspirin Salicylates; Reye’s Syndrome Warning Apr. 17 18869 Antidiarrheal Drug Products for Over-the-Counter Human Use; Final Monograph Apr. 17 18915 Antidiarrheal Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph May 7 24347 Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use May 29 32003 Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Health- care Antiseptic Drug Products; Reopening of Administrative Record May 29 32232 Oral HealthCare Drug Products for Over-the-Counter Human Use; Antiginigvitis/Antiplaque Drug Products; Establishment of Monograph Jun. 3 32981 Ophthalmic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment Jun. 3 33164 Guidance for Industry on Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate – Labeling Enforcement Policy; Availability Jun. 4 33362 Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph Jun. 4 33429 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the- Counter Human Use; propose Amendment of the Tentative Final Monograph Federal Register in 2003 (Volume 68) (continued) Date FR Page Document Title Jun. 9 34273 Antiperspirant Drug Products for Over-the-Counter Human Use; Final Monograph Jun. 13 35290 Skin Protectant Drug Products for Over-the-Counter Human Use; Astringent Drug Products, Final Monograph; Direct Final Rule Jun. 13 35346 Skin Protectant Drug Products for Over-the-Counter Human Use; Astringent Drug Products, Final Monograph; Proposed Rule Jun. 26 37963 Antidirheal Drug Products for Over-the-Counter Human Use; Final Monograph; Correction Jul. 11 41386 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients Jul. 17 42324 External Analgesic Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record and Amendment of Tentative Final Monograph Aug. 1 45257 Mercury Compounds in Drugs and Food; List Aug. 5 46133 Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph Aug. 25 50991 Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph; Extension of Comment Period; Correction Aug. 26 51167 Anorectal Drug Products for Over-the-Counter Human Use (Final Rule) Oct. 6 57642 Oral Healthcare Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Products; Establishment of a Monograph; Extension of Comment Period; Correction Oct. 9 58273 Skin Protectant Drug Products for Over-the-Counter Human Use; Astringent Drug Products; Final Monograph; Direct Final Rule; Confirmation of Effective date Oct. 22 60302 Laxative Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record Dec. 9 68509 Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph; Technical; Amendment Dec. 31 75414 Pediculicide Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph Dec. 31 75585 Over-the-Counter Drug Products; Safety Efficacy Review Federal Register in 2004 (Volume 68) Date FR Page Document Title Jan. 22 3005 Skin Protectant Drug Products for Over-the-Counter Human Use; Astringent Drug Products; Final Monograph, Direct Final Rule; and Confirmation of Effective Date; Corrections Feb. 10 6309 Draft Guidance for Industry on Time and Extent Applications; Availability Feb. 18 7652 Over-the-Counter Drug Products; Safety and efficacy Review, Additional Dandruff Control Ingredient Mar. 24 13717 Drug Labeling; Sodium Labeling for Over-the-Counter Drugs; Technical amendment; Termination of Delay of effective Date; Compliance Dates Mar. 24 13725 Drug labeling; orally Ingested Over-the-Counter Drug Products Containing Calcium. Magnesium. And Potassium Mar. 24 13765 Drug Labeling; Sodium Labeling for Over-the-counter Drugs May 12 26301 Antidiarheal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph May 19 28932 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient; Extension of Comment Period Ju.l 6 40640 Over-the-Counter Drug Products; Safety and Efficacy Review; Review Additional Antigingivitis/ Antiplaque Ingredient Aug. 2 46119 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph for Over-the-Counter Nasal Decongestant Drug Products Aug. 19 51362 Skin Protectant Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment Aug. 23 51852 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Antidiarheal Ingredient Sept. 3 53801 Over-the-Counter Human Drugs; Labeling Requirements; Delay of Implementation Date Oct. 15 61148 Antiperspirant Drug Products for Over-the-Counter Human Use; Final Monograph; Partial Stay; Reopening of the Administrative Record Nov. 2 69278 Drug Labeling; Sodium Labeling for Over-the-Counter Drugs Dec. 9 71420 Draft Compliance Guidance for Small Business Entities of Labeling Over-the- Counter Human Drug Products; Availability Federal Register in 2005 (Volume 70) Date FR Page Document Title Jan. 4 362 Agency Information Collection Activities; Proposed Collection; Comment request; Format and Content Requirements for Over-the-Counter Drug Products Labeling Jan. 5 741 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 Jan. 13 2415 Draft Guidance for Industry on Labeling Over-the-Counter Human Drug products; Questions and answers; Availability Mar. 29 15864 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request. Format and Content for Over-the- Counter Drug Products Labeling Mar. 29 15864 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content for Over-the- Counter Drug Product Labeling Jul. 11 39776 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Over-the-Counter Human Drugs; Labeling Requirements Jul. 13 40232 Cold, Cough. Allergy. Bronchodilator. And Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph for Combination Drug Products Jul. 13 40237 Cold, Cough. Allergy. Bronchodilator. And Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Monograph for Over- the-Counter Bronchodilator Drug Products Oct. 11 58974 Cold, Cough. Allergy. Bronchodilator. And Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for Over-the-Counter Bronchodilator Drug Product Dec. 5 72447 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Acne Ingredient Dec. 5 72448 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient Dec. 5 72449 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients Federal Register in 2005 (Volume 70)(continued) Date FR Page Document Title Dec. 9 73178 Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Proposed Amendment to the Monograph Dec. 22 75988 Phenylpropanolamine – Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monographs Federal Register in 2006 (Volume 71) Date FR Page Document Title Jan. 13 2309 Phenylpropanolamine – Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monographs; Correction Jun. 22 35917 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient Jul. 26 42405 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients Aug. 1 43358 Cold, Cough, Allergy Bronchodilator, and Antiasthmatic Drug Products for Over- the-Counter Human Use; Amendment of Monograph for OTC Nasal Decongestant Drug Products Aug. 29 51146 Skin Bleaching Drug Products for Over-the-Counter Human Use; Proposed Rule Dec. 12 74474 Over-the-Counter Human Drugs; Labeling Requirements; Proposed Rule Dec. 26 77314 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the- Counter Human Use; Proposed Amendment of the Tentative Final Monograph Federal Register in 2007 (Volume 72) Date FR Page Document Title Feb. 22 7941 Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use; Request for Information and Comments Mar. 6 9849 Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-th-Counter Human Use; amendment to the Monograph Mar. 19 12730 Cold, Cough allergy. Bronchodilator, and Antiasthmatic Drug Products for Over- the-Counter, Technical Amendment Mar. 29 14669 Laxative Drug Products for Over-the-Counter Human Use; Psyllium Ingredients in Granular Dosage Forms Mar. 30 15043 New drugs Exempted From Prescription – Dispensing Requirements; Technical Amendment Aug. 27 49070 Sunscreen Drug Products for Over-the Counter Human Use; Proposed Amendment of Final Monograph Nov. 28 67264 Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph; Extension of Comment Period Nov. 30 67639 Cold, Cough allergy. Bronchodilator, and Antiasthmatic Drug Products for Over- the-Counter Human Use, Final rule for Over-the-Counter Antitussive Drug Products; Technical Amendment Dec. 19 71769 Over-the-Counter Vaginal Contraceptive and spermicide Drug Products Containing Nonoxynol 8; Require Labeling Federal Register in 2008 (Volume 73) Date FR Page Document Title Jan. 3 402 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Feb. 1 6014 Skin Protectant Drug Products for Over-the-Counter Human Use; Reduced Labeling; Technical Amendment Jun. 19 34895 Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients Aug. 4 45227 Draft Guidance for industry on Labeling OTC Skin Protectant Drug Products; Availability Aug. 25 50033 Over the Counter Cough and Cold Medications for Pediatric Use; Notice of Public Hearing Sept. 2 51309 Over the Counter Cough and Cold Medication for Pediatric Use; Notice of Public Hearing; Correction Sept. 12 53029 Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety and Effectiveness Data Oct. 28 63886 Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products Dec. 11 75436 Guidance for Industry on Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers; Availability Dec. 12 75625 Withdrawal of Certain Proposed Rules and Other Proposed Actions Federal Register in 2009 (Volume 74) Date FR Page Document Title Jan. 5 303 Guidance for Industry on Labeling Over-the-Counter Human Drug Products - Questions and Answers; Availability Mar. 6 9759 Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products for Over-the-Counter Human Use; Technical Amendment Apr. 7 15741 Sodium Shale Oil Sulfonate Eligibility for Inclusion in Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products for Human Use; Request for Safety and Effectiveness Data Apr. 29 19385 Final Monograph: Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use May 1 20322 Draft Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability Jun. 30 31177 Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Corrections Jul. 14 34023 Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application Aug. 20 42080 Educating the Public About Removal of Essential-Use Designation for Epinephrine; Public Workshop; Request for Comments Sept. 1 45222 Guidance for Industry on Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers; Availability Oct. 27 55245 Saccharomyces boulardii Eligibility for Consideration To Be Added to the Over- the-Counter Drug Monograph for Antidiarrheal Drug Products; Request for Safety and Effectiveness Data; Withdrawal Nov. 5 57319 Draft Guidance for Industry on Dosage Delivery Devices for Over-the-Counter Liquid Drug Products; Availability Nov. 25 61512 Organ-Specific Warnings; Internal Analgesic, Antipyretic, and An