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withdrawn,object_id FDA-1981-N-0114-0030,FDA,FDA-1981-N-0114,"Letter to Morgan, Lewis & Bockius, LLP from FDA CDER",Other,Letter(s),2020-11-02T05:00:00Z,2020,11,2020-11-02T05:00:00Z,,2020-11-02T18:17:24Z,,0,0,0900006484946740 FDA-1981-N-0114-0016,FDA,FDA-1981-N-0114,List of References - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule],Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:17:32Z,,0,0,0900006480ab41ce FDA-1981-N-0114-0017,FDA,FDA-1981-N-0114,"Reference 3 - ""Comment No. C4, 1981N-114A"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:18:11Z,,0,0,0900006480ab4260 FDA-1981-N-0114-0020,FDA,FDA-1981-N-0114,"Reference 11 - ""Comment No. LET19, 1981N-0114"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:19:59Z,,0,0,0900006480ab46ef FDA-1981-N-0114-0004,FDA,FDA-1981-N-0114,"Nonprescription Drug Manufacturers Association (NDMA) to FDA/CDER, October 7, 1991 - Letter",Other,LET-Letter,2010-03-04T05:00:00Z,2010,3,2010-03-04T05:00:00Z,,2010-03-04T23:56:07Z,,0,0,09000064805b0534 FDA-1981-N-0114-0006,FDA,FDA-1981-N-0114,FDA/CDER to Nonprescription Drug Manufacturers Association (NDMA) - Letter,Other,LET-Letter,2010-03-04T05:00:00Z,2010,3,2010-03-04T05:00:00Z,,2010-03-04T23:56:11Z,,0,0,09000064805b053b FDA-1981-N-0114-0005,FDA,FDA-1981-N-0114,"FDA/CDER and the National Consumers League (NCL), October 9, 1981 - Memorandum of Telephone Conversation",Other,MT-Memorandum of Telephone Conversation,2010-03-04T05:00:00Z,2010,3,2010-03-04T05:00:00Z,,2010-03-04T23:56:09Z,,0,0,09000064805b0535 FDA-1981-N-0114-0003,FDA,FDA-1981-N-0114,Topical Acne Drug Products For Over-The-Counter Human Use; Amendment of Tenative Final Monograph; Reopening of Comment Period,Notice,NPR-Notice of Proposed Rule-Making,2010-03-04T05:00:00Z,2010,3,2010-03-04T05:00:00Z,1991-11-08T04:59:59Z,2010-03-04T23:56:06Z,,0,0,09000064805b0536 FDA-1981-N-0114-0021,FDA,FDA-1981-N-0114,"Reference 12 - ""Comment No. LET20, 1981N-0114"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:20:47Z,,0,0,0900006480ab46f0 FDA-1981-N-0114-0029,FDA,FDA-1981-N-0114,"Reference 22 - ""FDA Labeling Cost Model, Final Report"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:25:20Z,,0,0,0900006480ab4875 FDA-1981-N-0114-0007,FDA,FDA-1981-N-0114,"FDA/CDER and Nonprescription Drug Manufacturers Association (NDMA) Meeting, July 27, 1992 re Benzoyl Peroxide-Ultra Violet Light Testing Protocol - Memorandum of Meeting",Other,MM-Memorandum of Meeting,2010-03-04T05:00:00Z,2010,3,2010-03-04T05:00:00Z,,2010-03-04T23:56:12Z,,0,0,09000064805b053c FDA-1981-N-0114-0027,FDA,FDA-1981-N-0114,"Reference 18 - ""Comment No. C1, Target Health Inc., 1992N-0311"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:24:12Z,,0,0,0900006480ab4870 FDA-1981-N-0114-0018,FDA,FDA-1981-N-0114,"Reference 5 - ""International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:18:45Z,,0,0,0900006480ab42df FDA-1981-N-0114-0023,FDA,FDA-1981-N-0114,"Reference 14 - ""Comment No. LET22, 1981N-0114"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:22:06Z,,0,0,0900006480ab486c FDA-1981-N-0114-0028,FDA,FDA-1981-N-0114,"Reference 21 - ""Comment No. C2, Wholesale Druggists' Association, 1992N-0311"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:24:49Z,,0,0,0900006480ab4874 FDA-1981-N-0114-0022,FDA,FDA-1981-N-0114,"Reference 13 - ""Comment No. LET21, 1981N-0114"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:21:19Z,,0,0,0900006480ab46f1 FDA-1981-N-0114-0002,FDA,FDA-1981-N-0114,Topical Acne Drug Products For Over-The-Counter Human Use; Amendment of Tenative Final Monograph,Proposed Rule,NPR-Notice of Proposed Rule-Making,2010-03-04T05:00:00Z,2010,3,2010-03-04T05:00:00Z,1991-10-08T03:59:59Z,2010-03-04T23:56:04Z,,0,0,09000064805b052f FDA-1981-N-0114-0008,FDA,FDA-1981-N-0114,"FDA/CDER to Dockets Management Branch, August 7, 1991 - Public Administrative File for Over-The-Counter Topical Acne Drug Product Proposed Rulemaking, Docket No. 81N-0114A - Memorandum",Other,M-Memorandum,2010-03-04T05:00:00Z,2010,3,2010-03-04T05:00:00Z,,2013-07-27T23:09:56Z,,0,0,0900006480aae9d1 FDA-1981-N-0114-0024,FDA,FDA-1981-N-0114,"Reference 15 - ""Comment No. RPT4, 1981N-0114"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:22:36Z,,0,0,0900006480ab486d FDA-1981-N-0114-0026,FDA,FDA-1981-N-0114,"Reference 17 - ""Comment No. C4, NDMA, 1992N-0311"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:23:37Z,,0,0,0900006480ab486f FDA-1981-N-0114-0001,FDA,FDA-1981-N-0114,Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule,Rule,NFR-Notice of Final Rule,2010-03-04T05:00:00Z,2010,3,,,2011-06-11T16:25:43Z,2010-04424,0,0,0900006480ab4db0 FDA-1981-N-0114-0019,FDA,FDA-1981-N-0114,"Reference 10 - ""Comment No. RPT3, 1981N-0114"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:19:21Z,,0,0,0900006480ab46ee FDA-1981-N-0114-0025,FDA,FDA-1981-N-0114,"Reference 16 - ""Comment No. C3, American Academy of Dermatology, 1992N-0311"" - [Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use; Final Rule]",Supporting & Related Material,BKG-Background Material,2010-03-04T05:00:00Z,2010,3,,,2010-03-08T06:23:12Z,,0,0,0900006480ab486e