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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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29 rows where docket_id = "FDA-2003-N-0196" and posted_year = 2014 sorted by posted_date descending

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  • 2014 · 29 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-N-0196-0055 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Initial Determination and Feedback Letter from FDA/CDER to L'Oreal USA Products, Inc re Time and Extent Application (TEA) Drometrizole Trisiloxane for use in Over-the-Counter (OTC) Sunscreens Other Letter(s) 2014-08-29T04:00:00Z 2014 8 2014-08-29T04:00:00Z   2014-08-29T21:20:12Z   0 0 09000064818511a4
FDA-2003-N-0196-0054 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Letter from FDA/CDER to BASF AG (Morgan, Lewis & Bockius LLP) Other Letter(s) 2014-06-23T04:00:00Z 2014 6 2014-06-23T04:00:00Z   2014-06-23T18:14:09Z   0 0 090000648175c494
FDA-2003-N-0196-0053 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Supplement from BASF AG (Morgan Lewis & Bockius, LLP) Other Supplement (SUP) 2014-06-11T04:00:00Z 2014 6 2014-06-11T04:00:00Z   2014-06-11T15:51:37Z   0 0 090000648048b765
FDA-2003-N-0196-0051 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Data and Information from BASF AG (Morgan Lewis & Bockius, LLP) Other Submission of Information 2014-06-11T04:00:00Z 2014 6 2014-06-11T04:00:00Z   2014-06-11T15:48:23Z   0 0 090000648173afac
FDA-2003-N-0196-0052 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Supplement from BASF AG (Morgan Lewis & Bockius, LLP) Other Supplement (SUP) 2014-06-11T04:00:00Z 2014 6 2014-06-11T04:00:00Z   2014-06-11T15:49:59Z   0 0 090000648048b660
FDA-2003-N-0196-0048 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Letter from Symrise North America Cosmetic Division Other Letter(s) 2014-06-09T04:00:00Z 2014 6 2014-06-09T04:00:00Z   2014-06-09T21:19:55Z   0 0 090000648048b606
FDA-2003-N-0196-0047 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Letter from Buchanan Ingersoll to the Division of Over-The-Counter Drug Products, July 25, 2003 Other Letter(s) 2014-06-09T04:00:00Z 2014 6 2014-06-09T04:00:00Z   2014-06-09T21:12:37Z   0 0 090000648048b600
FDA-2003-N-0196-0049 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Letter from FDA/CDER to BASF AG (Morgan, Lewis & Bockius LLP) Other Letter(s) 2014-06-09T04:00:00Z 2014 6 2014-06-09T04:00:00Z   2014-06-09T21:29:26Z   0 0 090000648048b61b
FDA-2003-N-0196-0050 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Supplement from BASF AG (Morgan Lewis & Bockius, LLP) Other Supplement (SUP) 2014-06-09T04:00:00Z 2014 6 2014-06-09T04:00:00Z   2014-06-09T22:01:14Z   0 0 090000648048b622
FDA-2003-N-0196-0039 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 8 Test Substance G 4375 Content in Rat Plasma re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:36:48Z   0 0 090000648170431f
FDA-2003-N-0196-0044 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 12 Report re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:52:30Z   0 0 090000648170445e
FDA-2003-N-0196-0040 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 7 Test Item G 4375 Content in Rat Plasma re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:37:09Z   0 0 090000648170431e
FDA-2003-N-0196-0046 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 14 Clinical Evaluation of the Cutaneous Tolerance and Acceptance of a Cosmetic Product Applied Under Normal Conditions of Use in the Sun for Three Weeks by 30 Children re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-07-16T19:26:05Z   0 0 0900006481704460
FDA-2003-N-0196-0045 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 13 Pediatric Use Study Reports re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:57:41Z   0 0 090000648170445f
FDA-2003-N-0196-0035 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 3 Admentment No. 1 to Final Report Dated 21 March 1996 re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:24:32Z   0 0 090000648170431a
FDA-2003-N-0196-0037 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 5 Test to Evaluate PhotoAllergic in the Guinea Pig re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:30:13Z   0 0 090000648170431c
FDA-2003-N-0196-0043 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 11 English Summary of the Report re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:48:46Z   0 0 090000648170445d
FDA-2003-N-0196-0036 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 4 re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:29:41Z   0 0 090000648170431b
FDA-2003-N-0196-0034 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 2 re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:24:53Z   0 0 0900006481704319
FDA-2003-N-0196-0042 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 10 Human Safety Study Reports re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:48:37Z   0 0 090000648170445c
FDA-2003-N-0196-0038 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 6 Determination of G 4375 Content in Rat Plasma re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:30:31Z   0 0 090000648170431d
FDA-2003-N-0196-0033 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 1 Time and Extension Application re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-07-16T19:23:25Z   0 0 0900006481704318
FDA-2003-N-0196-0041 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Volume 9 Test Report CCR Project 532003 re Data and Information from L'Oreal, USA Products, Inc. Supporting & Related Material Data 2014-05-19T04:00:00Z 2014 5     2014-05-19T22:44:43Z   0 0 0900006481704320
FDA-2003-N-0196-0031 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Response Letter from FDA CDER to Symrise, Inc., and Ego Pharmaceuticals Ltd re re Time and Extent Application TEA Other Letter(s) 2014-02-28T05:00:00Z 2014 2 2014-02-28T05:00:00Z   2014-05-14T11:33:42Z   0 0 09000064815e9304
FDA-2003-N-0196-0030 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Request for Extension from BASF AG and BASF Corporation Other Request for Extension 2014-02-14T05:00:00Z 2014 2 2014-02-14T05:00:00Z   2014-02-14T20:44:26Z   0 0 090000648048b5fd
FDA-2003-N-0196-0025 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Amiloxate USP Neo Heliopan E1000 by Symrise Safety Data Book 2 Other References (internal) (REF) 2014-01-07T05:00:00Z 2014 1 2014-01-07T05:00:00Z   2014-01-07T21:40:26Z   0 0 09000064814f1dc2
FDA-2003-N-0196-0027 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Amiloxate USP Neo Heliopan E1000 by Symrise Safety Data Book 4 Other References (internal) (REF) 2014-01-07T05:00:00Z 2014 1 2014-01-07T05:00:00Z   2014-02-28T18:17:37Z   0 0 09000064814f1dc4
FDA-2003-N-0196-0024 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Amiloxate, USP - Neo Heliopan E1000 by Symrise Safety Data Book 1 (EU Commission Approval and Opinion of SCCNFP, Animal safety testing tabs 1-15) Other References (internal) (REF) 2014-01-07T05:00:00Z 2014 1 2014-01-07T05:00:00Z   2014-01-07T21:40:20Z   0 0 09000064814f1dc1
FDA-2003-N-0196-0026 FDA Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Sunscreen Ingredients FDA-2003-N-0196 Amiloxate USP Neo Heliopan E1000 by Symrise Safety Data Book 3 Other References (internal) (REF) 2014-01-07T05:00:00Z 2014 1 2014-01-07T05:00:00Z   2014-01-07T21:40:32Z   0 0 09000064814f1dc3

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);