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withdrawn,object_id FDA-1992-N-0049-0034,FDA,FDA-1992-N-0049,"Reference 12 - ""Comment No. LET20, 1981N-0114"" - [Classification of Benzoyl Peroxide as Safe and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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:41Z,,0,0,0900006480ab4d30 FDA-1992-N-0049-0031,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:36Z,,0,0,0900006480ab48e8 FDA-1992-N-0049-0033,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:39Z,,0,0,0900006480ab4d2e FDA-1992-N-0049-0035,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:42Z,,0,0,0900006480ab4d32 FDA-1992-N-0049-0042,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:53Z,,0,0,0900006480ab4eaa FDA-1992-N-0049-0039,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:48Z,,0,0,0900006480ab4d3e FDA-1992-N-0049-0036,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:44Z,,0,0,0900006480ab4d3b FDA-1992-N-0049-0032,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:38Z,,0,0,0900006480ab4d2c FDA-1992-N-0049-0040,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:50Z,,0,0,0900006480ab4d3f FDA-1992-N-0049-0029,FDA,FDA-1992-N-0049,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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:33Z,,0,0,0900006480ab488e FDA-1992-N-0049-0037,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:45Z,,0,0,0900006480ab4d3c FDA-1992-N-0049-0030,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:35Z,,0,0,0900006480ab48e5 FDA-1992-N-0049-0041,FDA,FDA-1992-N-0049,"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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:51Z,,0,0,0900006480ab4ea5 FDA-1992-N-0049-0038,FDA,FDA-1992-N-0049,"Reference 16 - ""Comment No. C3, American Academy of Dermatology"" - [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,2010-03-08T05:00:00Z,2010,3,,,2010-03-08T06:40:47Z,,0,0,0900006480ab4d3d FDA-1992-N-0049-0028,FDA,FDA-1992-N-0049,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,2010,3,2010-03-04T05:00:00Z,,2010-03-08T06:09:32Z,,0,0,0900006480ab4f84 FDA-1992-N-0049-0023,FDA,FDA-1992-N-0049,NDMA (Nonprescription Drug Manufacturers Association - Request for Extension of Comment Due Date,Other,EXT-Request for Extension Comment Due Date,2010-02-25T05:00:00Z,2010,2,2010-02-25T05:00:00Z,,2013-07-27T21:29:03Z,,0,0,090000648052bd03 FDA-1992-N-0049-0002,FDA,FDA-1992-N-0049,Topical Drug Products Containing Benzoyl Peroxide; Required Labeling; Extension of Comment Period,Notice,NEC-Notice of Extension,1995-06-07T04:00:00Z,1995,6,1995-06-07T04:00:00Z,1995-07-18T03:59:59Z,2010-02-25T18:34:06Z,,0,0,090000648052bd0a FDA-1992-N-0049-0001,FDA,FDA-1992-N-0049,Topical Drug Products Containing Benzoyl Peroxide; Required Labeling,Proposed Rule,NPR-Notice of Proposed Rule-Making,1995-02-23T05:00:00Z,1995,2,1995-02-23T05:00:00Z,1995-05-19T03:59:59Z,2010-02-25T18:30:48Z,,0,0,090000648052bcf4 FDA-1992-N-0049-0022,FDA,FDA-1992-N-0049,Reference 13 - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling] - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling],Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T21:11:46Z,,0,0,090000648052bd26 FDA-1992-N-0049-0004,FDA,FDA-1992-N-0049,Background Material,Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2008-05-16T23:34:17Z,,0,0,090000648052bd0e FDA-1992-N-0049-0009,FDA,FDA-1992-N-0049,"Reference 2 - ""Kurokawa, et al., Studies on the Promoting and Complete Carcinogenic Activities of Some Oxidizing Chemicals in Skin Carcinogensis"" - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling]",Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T20:47:08Z,,0,0,090000648052bd19 FDA-1992-N-0049-0010,FDA,FDA-1992-N-0049,Reference 3 - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling],Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T21:06:34Z,,0,0,090000648052bd1a FDA-1992-N-0049-0008,FDA,FDA-1992-N-0049,"Reference 1 - ""Slaga, et al., Skin Tumor-Promoting Activity of Benzoyl Peroxide, a Widely Used Free Radical-Generating Compound"" - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling]",Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T20:42:29Z,,0,0,090000648052bd18 FDA-1992-N-0049-0007,FDA,FDA-1992-N-0049,"FDA Memorandum to Dockets Management Branch, February 22, 1995, Public Administrative File for Proposal Rule - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling]",Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T20:36:08Z,,0,0,090000648052bd17 FDA-1992-N-0049-0018,FDA,FDA-1992-N-0049,Background Material,Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2008-05-16T23:34:17Z,,0,0,090000648052bd22 FDA-1992-N-0049-0013,FDA,FDA-1992-N-0049,"Reference 1.2 - ""Correspondence and Memoranda"" - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling]",Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T20:55:48Z,,0,0,090000648052bd1d FDA-1992-N-0049-0017,FDA,FDA-1992-N-0049,Background Material,Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2008-05-16T23:34:17Z,,0,0,090000648052bd21 FDA-1992-N-0049-0005,FDA,FDA-1992-N-0049,"Reference 10 - ""Iversen, Carcinogenesis Studies with Benzoyl- Peroxide"" - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling]",Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T20:13:37Z,,0,0,090000648052bd12 FDA-1992-N-0049-0012,FDA,FDA-1992-N-0049,"Reference 17 - ""Physicians' Desk Reference, 47th Edition"" - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling]",Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T20:53:18Z,,0,0,090000648052bd1c FDA-1992-N-0049-0015,FDA,FDA-1992-N-0049,Background Material,Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2008-05-16T23:34:17Z,,0,0,090000648052bd1f FDA-1992-N-0049-0011,FDA,FDA-1992-N-0049,"Reference 16 - ""Hogan, et al., Studies on the Promoting and Complete Carcinogenic Activities of Some Oxidizing Chemicals in Skin Carcinogensis"" - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling]",Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T20:51:17Z,,0,0,090000648052bd1b FDA-1992-N-0049-0003,FDA,FDA-1992-N-0049,Background Material,Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2008-05-16T23:34:17Z,,0,0,090000648052bd0c FDA-1992-N-0049-0016,FDA,FDA-1992-N-0049,Background Material,Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2008-05-16T23:34:17Z,,0,0,090000648052bd20 FDA-1992-N-0049-0014,FDA,FDA-1992-N-0049,"Reference 7 - ""Comments C31, PR1, & PR2"" - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling]",Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T20:59:44Z,,0,0,090000648052bd1e FDA-1992-N-0049-0020,FDA,FDA-1992-N-0049,Background Material,Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2008-05-16T23:34:17Z,,0,0,090000648052bd24 FDA-1992-N-0049-0021,FDA,FDA-1992-N-0049,Background Material,Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2008-05-16T23:34:17Z,,0,0,090000648052bd25 FDA-1992-N-0049-0019,FDA,FDA-1992-N-0049,Background Material,Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2008-05-16T23:34:17Z,,0,0,090000648052bd23 FDA-1992-N-0049-0006,FDA,FDA-1992-N-0049,"Reference 11 - ""Iversen, Skin Tumorigenesis and Carcinogenesis Studies With7,12-Dimethylbenz[a]anthracene, Ultraviolet Light, Benzoyl Peroxide (Panoxyl gel 5%) and Ointment Gel "" - [Topical Drug Products Containing Benzoyl Peroxide; Required Labeling]",Supporting & Related Material,BKG-Background Material,1995-02-17T05:00:00Z,1995,2,,,2010-02-25T20:24:04Z,,0,0,090000648052bd14