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withdrawn,object_id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-2008-N-0474-0038,FDA,FDA-2008-N-0474,L'Oreal Response Letter from October 2015 Submission,Other,Answer,2016-06-27T04:00:00Z,2016,6,2016-06-27T04:00:00Z,,2016-06-27T18:31:56Z,,0,0,0900006482071493
FDA-2008-N-0474-0037,FDA,FDA-2008-N-0474,"Letter from FDA CDER to L'Oreal USA Products, Inc.",Other,Letter(s),2015-12-14T05:00:00Z,2015,12,2015-12-14T05:00:00Z,,2015-12-14T20:53:46Z,,0,0,0900006481da43dc
FDA-2008-N-0474-0036,FDA,FDA-2008-N-0474,Letter from L'Oreal USA Products Inc. to FDA CDER,Other,Letter(s),2015-10-13T04:00:00Z,2015,10,2015-10-13T04:00:00Z,,2015-10-13T13:22:00Z,,0,0,0900006481cc3e87
FDA-2008-N-0474-0035,FDA,FDA-2008-N-0474,Advice Letter from FDA CDER to L'Oreal USA Products Inc,Other,Letter(s),2015-09-02T04:00:00Z,2015,9,2015-09-02T04:00:00Z,,2015-09-02T15:26:52Z,,0,0,0900006481c50275
FDA-2008-N-0474-0034,FDA,FDA-2008-N-0474,Response to FDA Meeting Minutes May 11. 2015 from L'Oreal USA,Other,Minutes,2015-07-21T04:00:00Z,2015,7,2015-07-21T04:00:00Z,,2015-07-21T15:05:49Z,,0,0,0900006481b954ba
FDA-2008-N-0474-0033,FDA,FDA-2008-N-0474,"Memorandum of Meeting Minutes May 11, 2015 between FDA CDER and L'Oreal USA Products Inc.",Other,Memorandum,2015-06-12T04:00:00Z,2015,6,2015-06-12T04:00:00Z,,2015-06-12T14:51:44Z,,0,0,0900006481b30d22
FDA-2008-N-0474-0029,FDA,FDA-2008-N-0474,"Request for a Meeting from L'Oreal USA Products, Inc to FDA CDER",Other,Request,2015-05-01T04:00:00Z,2015,5,2015-05-01T04:00:00Z,,2015-05-01T14:31:21Z,,0,0,0900006481a6df2d
FDA-2008-N-0474-0032,FDA,FDA-2008-N-0474,Response from FDA CDER to L'Oreal USA Products Inc,Other,Response(s),2015-05-01T04:00:00Z,2015,5,2015-05-01T04:00:00Z,,2015-05-01T16:54:55Z,,0,0,0900006481ac7a72
FDA-2008-N-0474-0024,FDA,FDA-2008-N-0474,"Reference 6 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T16:00:53Z,,0,0,0900006481a113a5
FDA-2008-N-0474-0019,FDA,FDA-2008-N-0474,"Reference 1 - FDA, Guidance for Industry, Photosafety Testing, May 2003",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T15:59:35Z,,0,0,0900006481a113a0
FDA-2008-N-0474-0028,FDA,FDA-2008-N-0474,"Reference 10 - International Conference on Harmonization (ICH) Guideline for Industry, Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T16:01:35Z,,0,0,0900006481a113b5
FDA-2008-N-0474-0022,FDA,FDA-2008-N-0474,"Reference 4 - Schmidt et al, Photoallergic Contact Dermatitis Due to Combined UVB (4-Methylbenzylidene Camphor/Octyl Methoxycinnamate) and UVA (Benzophenone-3/Butyl Methoxydibenzoylmethane) Absorber Sensitization",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T16:00:22Z,,0,0,0900006481a113a3
FDA-2008-N-0474-0018,FDA,FDA-2008-N-0474,"Over-the-Counter Sunscreen Drug Products—Regulatory Status of
Ecamsule",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2015-02-25T05:00:00Z,2015,2,2015-02-25T05:00:00Z,2015-04-14T03:59:59Z,2015-05-02T02:02:23Z,2015-03883,0,0,0900006481a16312
FDA-2008-N-0474-0020,FDA,FDA-2008-N-0474,"Reference 2 - Leonard et al, The New Standard Battery of Photopatch Test in France.",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T16:00:03Z,,0,0,0900006481a113a1
FDA-2008-N-0474-0027,FDA,FDA-2008-N-0474,"Reference 9 - International Conference on Harmonization (ICH)  Harmonized Tripartite Guideline for Industry Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2), 2005",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T16:01:25Z,,0,0,0900006481a113b4
FDA-2008-N-0474-0021,FDA,FDA-2008-N-0474,"Reference 3 - Schauder et al, Contact and Photocontact Sensitivity to Sunscreens. Review of a 15-Year Experience and of the Literature",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T16:00:12Z,,0,0,0900006481a113a2
FDA-2008-N-0474-0023,FDA,FDA-2008-N-0474,"Reference 5 - FDA Guidance for Industry, Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application, February 1987",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T16:00:39Z,,0,0,0900006481a113a4
FDA-2008-N-0474-0026,FDA,FDA-2008-N-0474,"Reference 8 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies (Revision 1), September 2008",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T16:01:16Z,,0,0,0900006481a113a7
FDA-2008-N-0474-0025,FDA,FDA-2008-N-0474,"Reference 7 - International Conference on Harmonization (ICH) Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997",Supporting & Related Material,Background Material,2015-02-25T05:00:00Z,2015,2,,,2015-02-25T16:01:04Z,,0,0,0900006481a113a6
FDA-2008-N-0474-0015,FDA,FDA-2008-N-0474,"Volume 9 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T14:35:33Z,,0,0,0900006481a093e5
FDA-2008-N-0474-0010,FDA,FDA-2008-N-0474,"Volume 4 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T13:43:58Z,,0,0,0900006481a093e0
FDA-2008-N-0474-0016,FDA,FDA-2008-N-0474,"Volume 10 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T14:39:32Z,,0,0,0900006481a09458
FDA-2008-N-0474-0009,FDA,FDA-2008-N-0474,"Volume 3 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T13:43:51Z,,0,0,0900006481a093df
FDA-2008-N-0474-0008,FDA,FDA-2008-N-0474,"Volume 2 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T13:43:42Z,,0,0,0900006481a093de
FDA-2008-N-0474-0013,FDA,FDA-2008-N-0474,"Volume 7 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T14:07:52Z,,0,0,0900006481a093e3
FDA-2008-N-0474-0012,FDA,FDA-2008-N-0474,"Volume 6 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T13:57:17Z,,0,0,0900006481a093e2
FDA-2008-N-0474-0011,FDA,FDA-2008-N-0474,"Volume 5 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T13:49:38Z,,0,0,0900006481a093e1
FDA-2008-N-0474-0017,FDA,FDA-2008-N-0474,"Volume 11 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T15:10:39Z,,0,0,0900006481a09459
FDA-2008-N-0474-0014,FDA,FDA-2008-N-0474,"Volume 8 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T14:15:05Z,,0,0,0900006481a093e4
FDA-2008-N-0474-0007,FDA,FDA-2008-N-0474,"Volume 1 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006",Supporting & Related Material,Background Material,2015-02-19T05:00:00Z,2015,2,,,2015-02-19T13:17:08Z,,0,0,0900006481a093dd
FDA-2008-N-0474-0003,FDA,FDA-2008-N-0474,"Time and Extent Application (TEA) from  L'Oreal USA Products, Inc., and Reference 1 - TEA for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated September 18, 2007, Background Material Book 2",Supporting & Related Material,Background Material,2008-09-15T04:00:00Z,2008,9,,,2015-02-18T19:45:14Z,,0,0,090000648070674b
FDA-2008-N-0474-0002,FDA,FDA-2008-N-0474,"Time and Extent Application (TEA) from L'Oreal USA Products, Inc., and Reference 1 - TEA for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated September 18, 2007, Background Material Book 1",Supporting & Related Material,Background Material,2008-09-15T04:00:00Z,2008,9,,,2015-02-18T19:42:31Z,,0,0,0900006480706718
FDA-2008-N-0474-0005,FDA,FDA-2008-N-0474,"Report/Review of Time and Extent Application (TEA) from FDA CDER for L'Oreal USA Products, Inc., TEA (Terephthalylidene Dicamphor Sufonic Acid) dated September 25, 2007",Supporting & Related Material,Report,2008-09-15T04:00:00Z,2008,9,,,2015-02-18T19:48:57Z,,0,0,09000064807067a2
FDA-2008-N-0474-0004,FDA,FDA-2008-N-0474,"Time and Extent Application (TEA) Amendment from  L'Oreal USA Products, Inc., and Reference 1 - TEA for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated February 5, 2008",Supporting & Related Material,Background Material,2008-09-15T04:00:00Z,2008,9,,,2015-02-18T19:46:06Z,,0,0,0900006480706777
FDA-2008-N-0474-0001,FDA,FDA-2008-N-0474,Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety and Effectiveness Data,Notice,Requests for Information (RFI),2008-09-12T04:00:00Z,2008,9,2008-09-12T04:00:00Z,2008-12-12T04:59:59Z,2015-02-20T03:01:32Z,E8-21291,0,0,09000064807017ef