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withdrawn,object_id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-2005-N-0453-0055,FDA,FDA-2005-N-0453,DSM Nutritional Products June 7 2019 Meeting Minutes,Other,Minutes,2019-08-28T04:00:00Z,2019,8,2019-08-28T04:00:00Z,,2019-08-28T18:40:49Z,,0,0,0900006483ed5517
FDA-2005-N-0453-0054,FDA,FDA-2005-N-0453,Letter from FDA CDER to DSM Nutritional Products LLC,Other,Letter(s),2019-06-05T04:00:00Z,2019,6,2019-06-05T04:00:00Z,,2019-06-05T15:49:14Z,,0,0,0900006483ced582
FDA-2005-N-0453-0053,FDA,FDA-2005-N-0453,Request for Type C Meeting from DSM,Other,Request,2019-05-01T04:00:00Z,2019,5,2019-05-01T04:00:00Z,,2019-05-01T18:52:26Z,,0,0,0900006483c25323
FDA-2005-N-0453-0052,FDA,FDA-2005-N-0453,Request for Non Public Meeting from DSM Nutritional Products,Other,Request,2019-01-29T05:00:00Z,2019,1,2019-01-29T05:00:00Z,,2019-01-29T18:45:00Z,,0,0,0900006483a2238b
FDA-2005-N-0453-0051,FDA,FDA-2005-N-0453,"MEMORANDUM OF MEETING MINUTES - BASF Bemotrizinol and Bisoctrizole October 12, 2017",Other,Memorandum,2017-11-15T05:00:00Z,2017,11,2017-11-15T05:00:00Z,,2017-11-15T17:48:04Z,,0,0,0900006482c7b23a
FDA-2005-N-0453-0050,FDA,FDA-2005-N-0453,"Revision from BASF (Morgan, Lewis & Bockius LLP)",Other,Correction(s),2017-09-29T04:00:00Z,2017,9,2017-09-29T04:00:00Z,,2017-09-29T20:24:09Z,,0,0,0900006482b8cb9f
FDA-2005-N-0453-0049,FDA,FDA-2005-N-0453,Meeting Granted Letter BASF August 28 2017 Meeting Request,Other,Memorandum,2017-09-19T04:00:00Z,2017,9,2017-09-19T04:00:00Z,,2017-09-19T18:12:14Z,,0,0,0900006482b4f4e1
FDA-2005-N-0453-0048,FDA,FDA-2005-N-0453,"Meeting Materials from BASF (Morgan, Lewis & Bockius LLP)",Other,Meeting Exhibits,2017-09-12T04:00:00Z,2017,9,2017-09-12T04:00:00Z,,2017-09-29T20:24:44Z,,0,0,0900006482b2bf58
FDA-2005-N-0453-0047,FDA,FDA-2005-N-0453,"Request for Meeting from BASF (Morgan, Lewis & Bockius LLP)",Other,Request,2017-09-01T04:00:00Z,2017,9,2017-09-01T04:00:00Z,,2017-09-01T18:56:18Z,,0,0,0900006482b03dc4
FDA-2005-N-0453-0045,FDA,FDA-2005-N-0453,"Letter from BASF SE (Morgan, Lewis & Bockius LLP)",Other,Letter(s),2015-10-15T04:00:00Z,2015,10,2015-10-15T04:00:00Z,,2015-10-15T14:41:58Z,,0,0,0900006481ccce50
FDA-2005-N-0453-0046,FDA,FDA-2005-N-0453,"Advice Letter from FDA CDER to Morgan, Lewis & Bockius LLP",Other,Letter(s),2015-10-15T04:00:00Z,2015,10,2015-10-15T04:00:00Z,,2015-10-15T14:42:13Z,,0,0,0900006481ccce52
FDA-2005-N-0453-0042,FDA,FDA-2005-N-0453,"Memorandum of Meeting Minutes between FDA CDER and BASF regarding Octyl Triazone and Bemotrizinol March 19, 2015",Other,Memorandum,2015-06-15T04:00:00Z,2015,6,2015-06-15T04:00:00Z,,2015-06-15T17:13:28Z,,0,0,0900006481b37e78
FDA-2005-N-0453-0043,FDA,FDA-2005-N-0453,"Memorandum of Meeting Minutes between FDA CDER and BASF Corporation regarding bisoctrizole March 20, 2015",Other,Memorandum,2015-06-15T04:00:00Z,2015,6,2015-06-15T04:00:00Z,,2015-06-15T17:13:48Z,,0,0,0900006481b37e79
FDA-2005-N-0453-0041,FDA,FDA-2005-N-0453,"Letter from FDA/CDER to Morgan, Lewis & Bockius, LLP (BASF SE) Granting Meeting Request Regarding GRASE Status of Octyl Triazone and Bemotrizinol",Other,Letter(s),2015-03-09T04:00:00Z,2015,3,2015-03-09T04:00:00Z,,2015-03-09T13:44:40Z,,0,0,0900006481a33de1
FDA-2005-N-0453-0040,FDA,FDA-2005-N-0453,"Letter from FDA/CDER to Morgan, Lewis & Bockius, LLP (BASF SE) Granting Meeting Request Regarding GRASE Status of Bisoctrizole",Other,Letter(s),2015-03-09T04:00:00Z,2015,3,2015-03-09T04:00:00Z,,2015-03-09T13:40:04Z,,0,0,0900006481a33ddd
FDA-2005-N-0453-0036,FDA,FDA-2005-N-0453,"Sunscreen Feedback Letters; Notice of Availability Under the Sunscreen
Innovation Act",Notice,Request for Comments,2015-01-07T05:00:00Z,2015,1,2015-01-07T05:00:00Z,2015-02-24T04:59:59Z,2015-02-24T03:08:50Z,2015-00002,0,0,09000064819a9732
FDA-2005-N-0453-0035,FDA,FDA-2005-N-0453,"Determination and Feedback Letter from FDA/CDER to Ciba Specialty Chemicals Corporation (Ciba) (Morgan, Lewis & Bockius LLP) re Time and Extent Application (TEA) Bemotrizinol for use in Over-the-Counter (OTC) Sunscreen",Other,Letter(s),2014-11-14T05:00:00Z,2014,11,2014-11-14T05:00:00Z,,2014-11-14T20:28:13Z,,0,0,090000648192f333
FDA-2005-N-0453-0034,FDA,FDA-2005-N-0453,"Initial Determination and Feedback Letter from FDA/CDER to Ciba Specialty Chemicals Corporation (Ciba) (Morgan, Lewis & Bockius LLP) re Time and Extent Application (TEA) Bemotrizinol  for use in Over-the-Counter (OTC) Sunscreens",Other,,2014-11-13T00:00:00Z,2014,11,,,2014-11-14T16:27:35Z,,0,1,090000648192d191
FDA-2005-N-0453-0028,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 8 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:28:36Z,,0,0,0900006481902a13
FDA-2005-N-0453-0022,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 2 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:20:46Z,,0,0,09000064819029b7
FDA-2005-N-0453-0025,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 5 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:22:33Z,,0,0,09000064819029bf
FDA-2005-N-0453-0031,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 11 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:30:27Z,,0,0,0900006481902a27
FDA-2005-N-0453-0021,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 1 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:19:48Z,,0,0,090000648190293f
FDA-2005-N-0453-0024,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 4 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:22:05Z,,0,0,09000064819029bb
FDA-2005-N-0453-0027,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 7 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:27:57Z,,0,0,0900006481902a10
FDA-2005-N-0453-0033,FDA,FDA-2005-N-0453,Bemotrizinol Dermal Carcinogenicity Summary re Supplement from Ciba Specialty Chemicals,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:34:50Z,,0,0,0900006481902a2b
FDA-2005-N-0453-0026,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 6 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:27:16Z,,0,0,09000064819029e2
FDA-2005-N-0453-0030,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 10 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:29:54Z,,0,0,0900006481902a25
FDA-2005-N-0453-0023,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 3 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:21:25Z,,0,0,09000064819029b9
FDA-2005-N-0453-0032,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 12 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:31:54Z,,0,0,0900006481902a29
FDA-2005-N-0453-0029,FDA,FDA-2005-N-0453,Tab. III A.12 Lifetime Dermal Carcinogenicity Study in Rats Volume 9 of 12 re Supplement from Ciba Specialty Chemicals Corporation,Supporting & Related Material,Background Material,2014-11-10T05:00:00Z,2014,11,,,2014-11-10T16:29:14Z,,0,0,0900006481902a17
FDA-2005-N-0453-0020,FDA,FDA-2005-N-0453,"Initial Determination and Feedback Letter from FDA/CDER to Ciba Specialty Chemicals Corporation (Ciba) (Morgan, Lewis & Bockius LLP) re Time and Extent Application (TEA) Bisoctrizole for use in Over-the-Counter (OTC) Sunscreens",Other,Letter(s),2014-09-03T04:00:00Z,2014,9,2014-09-03T04:00:00Z,,2014-09-03T21:02:03Z,,0,0,090000648185a6e7
FDA-2005-N-0453-0019,FDA,FDA-2005-N-0453,Ciba Specialty Chemicals Corporation Correspondence with FDA Center for Drug Evaluation & Research - Electronic Letter re FDA-2005-N-0453-0002 and FDA-2005-N-0453-0003,Other,Electronic Letter,2014-09-03T04:00:00Z,2014,9,2014-09-03T04:00:00Z,,2014-09-03T20:44:01Z,,0,0,09000064812be491
FDA-2005-N-0453-0017,FDA,FDA-2005-N-0453,Electronic Correspondence From Ciba to FDA re Confidential Information in Bisoctrizole and Bemotrizinol TEAs FDA-2005-N-0453-0001- Background,Supporting & Related Material,Background Material,2013-05-07T04:00:00Z,2013,5,,,2013-05-07T21:36:09Z,,0,0,09000064804507d4
FDA-2005-N-0453-0018,FDA,FDA-2005-N-0453,Electronic Correspondence From Ciba to FDA re Confidential Information in Bisoctrizole and Bemotrizinol TEAs FDA-2005-N-0453-0001 - Background,Supporting & Related Material,Background Material,2013-05-07T04:00:00Z,2013,5,,,2013-05-07T21:36:43Z,,0,0,09000064804507d9
FDA-2005-N-0453-0016,FDA,FDA-2005-N-0453,Skin Cancer Foundation to the Food and Drug Administration - Letter,Other,Letter(s),2008-08-19T04:00:00Z,2008,8,2008-08-19T04:00:00Z,,2019-07-05T19:37:20Z,,0,0,090000648063d6c7
FDA-2005-N-0453-0004,FDA,FDA-2005-N-0453,Time and Extent Application (TEA) Review for Bemotrizinol [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:00:12Z,,0,0,09000064804507cf
FDA-2005-N-0453-0005,FDA,FDA-2005-N-0453,Time and Extent Application (TEA) Review for Bisoctrizole [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:03:52Z,,0,0,09000064804507d0
FDA-2005-N-0453-0010,FDA,FDA-2005-N-0453,FDA Center for Drug Evaluation and Reseach (OTC) to Ciba Specialty Chemical Corporation Letter dated 10/31/2005 [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,BKG-Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:12:19Z,,0,0,09000064804507d8
FDA-2005-N-0453-0003,FDA,FDA-2005-N-0453,Ciba Specialty Chemicals Corporation - [Bemotrizinol] - Supplement,Other,Supplement (SUP),2008-06-13T04:00:00Z,2008,6,2008-06-13T04:00:00Z,,2013-05-07T21:31:57Z,,0,0,09000064804507e3
FDA-2005-N-0453-0013,FDA,FDA-2005-N-0453,Time and Extend Application Bemotrizinol [Product Labeling] [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:31:03Z,,0,0,09000064804507dc
FDA-2005-N-0453-0012,FDA,FDA-2005-N-0453,Time and Extend Application Bemotrizinol - [Appendices] [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:29:25Z,,0,0,09000064804507db
FDA-2005-N-0453-0009,FDA,FDA-2005-N-0453,Time and Extend Application Bisoctrizole [Product Labeling] [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:10:59Z,,0,0,09000064804507d7
FDA-2005-N-0453-0011,FDA,FDA-2005-N-0453,Time and Extend Application Bemotrizinol - [Prepared to support the Inclusion of Bemotrizinol  into FDA’s Monograph for Sunscreen Drug Products] [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:15:05Z,,0,0,09000064804507da
FDA-2005-N-0453-0007,FDA,FDA-2005-N-0453,Time and Extend Application Bisoctrizole - [Prepared to support the Inclusion of Bisoctrizole into FDA’s Monograph for Sunscreen Drug Products]  [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:06:46Z,,0,0,09000064804507d5
FDA-2005-N-0453-0008,FDA,FDA-2005-N-0453,Time and Extend Application Bisoctrizole - [Appendices] [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:09:09Z,,0,0,09000064804507d6
FDA-2005-N-0453-0002,FDA,FDA-2005-N-0453,Ciba Specialty Chemicals Corporation re Bisoctrizole - Supplement,Other,Supplement (SUP),2008-06-13T04:00:00Z,2008,6,2008-06-13T04:00:00Z,,2013-05-07T21:31:02Z,,0,0,09000064804507e2
FDA-2005-N-0453-0006,FDA,FDA-2005-N-0453,FDA Center for Drug Evaluation and Reseach (OTC) to Ciba Specialty Chemical Corporation Letter dated 10/31/2005 [FDA-2005-N-0453-0001] - Background,Supporting & Related Material,Background Material,2008-06-13T04:00:00Z,2008,6,,,2013-05-02T17:03:01Z,,0,0,09000064804507d3
FDA-2005-N-0453-0001,FDA,FDA-2005-N-0453,Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients,Notice,"NRD-Notice of Requesting Data, Info, & Views",2005-12-02T05:00:00Z,2005,12,2005-12-05T05:00:00Z,2006-03-07T04:59:59Z,2009-12-30T19:54:55Z,,0,0,09000064804507c9