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

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46 rows where docket_id = "FDA-1981-N-0015" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1981-N-0015-0060 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Supplement from Clinical Clean Inc. re Additional Data to be Considered Over the Counter Drug Products for the Reduction or Prevention of Dental Plaque and Gingivitis Establishment of a Monograph Other Supplement (SUP) 2023-04-04T04:00:00Z 2023 4     2023-04-04T15:34:00Z   0 0 09000064805aed38
FDA-1981-N-0015-0067 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Supplement from WhiteHill Oral Technologies, Inc. re Proposed Antiplaque/Antigingivitis OTC Drug Monograph Other Supplement (SUP) 2023-04-04T04:00:00Z 2023 4 2023-04-04T04:00:00Z   2023-04-04T16:11:24Z   0 0 09000064805aee8c
FDA-1981-N-0015-0056 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Letter to Morgan, Lewis & Bockius, LLP from FDA CDER Other Letter(s) 2020-11-02T05:00:00Z 2020 11 2020-11-02T05:00:00Z   2020-11-02T17:58:16Z   0 0 090000648494673e
FDA-1981-N-0015-0055 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Withdrawal of Time and Extent Applications (TEAs) from Morgan Lewis (BASF) Other Withdrawal 2016-08-29T04:00:00Z 2016 8 2016-08-29T04:00:00Z   2016-08-29T15:04:24Z   0 0 09000064821a8fe9
FDA-1981-N-0015-0054 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Shipping Label from Ciba Speciality Chemicals Corporation Ciba Supporting & Related Material Transmittals 2015-04-27T04:00:00Z 2015 4     2015-04-29T20:15:39Z   0 0 09000064805aee96
FDA-1981-N-0015-0053 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Shipping Label from Ciba Speciality Chemicals Corporation Ciba Supporting & Related Material Transmittals 2015-04-21T04:00:00Z 2015 4     2015-04-29T20:15:02Z   0 0 09000064805aed6b
FDA-1981-N-0015-0042 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Withdrawal from Colgate-Palmolive Company to FDA/CDER Other Withdrawal 2014-11-19T05:00:00Z 2014 11 2014-11-19T05:00:00Z   2015-06-12T13:19:37Z   0 0 0900006481536734
FDA-1981-N-0015-0040 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Citizen Petition from Colgate-Palmolive Company Other Citizen Petition 2012-05-18T04:00:00Z 2012 5 2012-05-18T04:00:00Z   2024-11-12T04:54:26Z   1 0 09000064810071d9
FDA-1981-N-0015-0041 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Acknowledgement Letter from FDA/CDER to Colgate-Palmolive Company Other Acknowledgement Letter/Receipt 2012-05-18T04:00:00Z 2012 5 2012-05-18T04:00:00Z   2015-04-29T16:09:40Z   0 0 0900006481007239
FDA-1981-N-0015-0039 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Letter from Consumer Healthcare Products Association (CHPA) re Oral Health Care Drug Products for OTC Human Use Other Letter(s) 2008-09-29T04:00:00Z 2008 9 2008-09-29T04:00:00Z   2015-04-29T17:41:20Z   0 0 0900006480702320
FDA-1981-N-0015-0038 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Letter from FDA CDER to Consumer Healthcare Products Association re 1981N-0033P Other Letter(s) 2008-08-15T04:00:00Z 2008 8 2008-08-15T04:00:00Z   2015-04-29T17:35:34Z   0 0 09000064806a1695
FDA-1981-N-0015-0036 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Letter from FDA/CDER to the Global Oral Care Procter & Gamble Company Other Letter(s) 2008-08-15T04:00:00Z 2008 8 2008-08-15T04:00:00Z   2015-04-29T17:28:03Z   0 0 09000064806a1584
FDA-1981-N-0015-0037 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Letter from FDA CDER to Combe Incorporated re Stephen Pennisi Other Letter(s) 2008-08-15T04:00:00Z 2008 8 2008-08-15T04:00:00Z   2015-04-29T17:36:29Z   0 0 09000064806a1623
FDA-1981-N-0015-0033 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Comment from HFD-560 to Colgate-Palmolive Company Other Answer 2005-04-18T04:00:00Z 2005 4     2015-04-28T19:47:18Z   0 0 09000064805aef36
FDA-1981-N-0015-0025 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Speciality Chemicals Corporation USA re Material Time and Extent Data Triclosan TEA Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-29T20:49:49Z   0 0 09000064805aeea7
FDA-1981-N-0015-0030 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re UK Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-29T20:32:02Z   0 0 09000064805aeeac
FDA-1981-N-0015-0014 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Appendix 1 Triclosan Safety Studies Submitted to OTC Docket 81 N-033P Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T13:56:00Z   0 0 09000064805aee9c
FDA-1981-N-0015-0016 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Australia Labels Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T14:02:57Z   0 0 09000064805aee9e
FDA-1981-N-0015-0021 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Brazil Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T13:25:43Z   0 0 09000064805aeea3
FDA-1981-N-0015-0031 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Germany Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-29T20:32:31Z   0 0 09000064805aeead
FDA-1981-N-0015-0011 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from FDA/CDER to Ciba Specialty Chemicals Corporation Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-05-11T16:37:37Z   0 0 09000064805aee99
FDA-1981-N-0015-0024 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Italy Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T13:18:52Z   0 0 09000064805aeea6
FDA-1981-N-0015-0012 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from FDA/CDER re Time and Extent Application (TEA) Review for Triclosan Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-05-11T16:38:08Z   0 0 09000064805aee9a
FDA-1981-N-0015-0028 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re France Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-29T20:37:08Z   0 0 09000064805aeeaa
FDA-1981-N-0015-0015 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re APPENDIX 2 Specifications Analytical Methods USP Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T13:58:55Z   0 0 09000064805aee9d
FDA-1981-N-0015-0022 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Canada Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T13:23:37Z   0 0 09000064805aeea4
FDA-1981-N-0015-0019 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Tab 1 Cumulative Volume of Triclosan Use (Kg/Year) in Oral Care Applications (AntigingivitislAntiplaque) By Geographic Region 1992-2003 re Comment from Ciba Specialty Chemicals Corporation USA Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T13:35:28Z   0 0 09000064805aeea1
FDA-1981-N-0015-0027 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re India Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-29T20:39:29Z   0 0 09000064805aeea9
FDA-1981-N-0015-0023 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Chile Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T13:21:05Z   0 0 09000064805aeea5
FDA-1981-N-0015-0026 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Speciality Chemicals Corporation USA re Follow-UD to Time and Extent ADDliCatiOD: Inclusion of Triclosan in OTC Monograph for Antigingivitis/Antiplaque Drug Products Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-29T20:43:31Z   0 0 09000064805aeea8
FDA-1981-N-0015-0017 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Division of OTC Drug Products, HFD-560 re 1981N-033P Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T14:15:22Z   0 0 09000064805aee9f
FDA-1981-N-0015-0010 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Antigingivitis/Antiplaque Ingredient; Notice of Requesting Data Notice NRD-Notice of Requesting Data, Info, & Views 2004-07-06T04:00:00Z 2004 7 2004-07-02T04:00:00Z 2004-10-05T03:59:59Z 2015-06-09T18:37:54Z   0 0 09000064805aee98
FDA-1981-N-0015-0018 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Follow-up to Time and Extent Application Inclusion of Triclosan in OTC Monograph for Antigingivitis/Antiplaque Drug Products (Docket No. 81N-033P) Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T14:10:59Z   0 0 09000064805aeea0
FDA-1981-N-0015-0029 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re China Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-29T20:35:00Z   0 0 09000064805aeeab
FDA-1981-N-0015-0013 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Time and Extent Application Triclosan USP Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T13:51:54Z   0 0 09000064805aee9b
FDA-1981-N-0015-0020 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Africa Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-30T13:29:14Z   0 0 09000064805aeea2
FDA-1981-N-0015-0032 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Background Material from Ciba Specialty Chemicals Corporation USA re Mexico Labels Supporting & Related Material Background Material 2004-07-06T04:00:00Z 2004 7     2015-04-29T20:24:21Z   0 0 09000064805aeeae
FDA-1981-N-0015-0009 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Notice of Correction from FDA CDER re Oral Health Care Drug Products for Over the Counter Human Use Antigingivitis Antiplaque Drug Products Establishment of a Monograph Extension of Comment Period Correction Notice Correction 2003-10-09T04:00:00Z 2003 10 2003-08-25T04:00:00Z 2003-11-26T04:59:59Z 2015-05-27T16:52:38Z   0 0 09000064805aed36
FDA-1981-N-0015-0008 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Notice of extension from FDA CDER re Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph; Extension of Comment Period Notice Notice of Extension 2003-08-27T04:00:00Z 2003 8 2003-08-25T04:00:00Z 2003-11-26T04:59:59Z 2015-05-27T16:46:12Z   0 0 09000064805aed33
FDA-1981-N-0015-0005 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Advance Notice of Proposed Rule from FDA/CDER re Oral Health Care Drug Products for Over-the-Counter Human Use Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2003-06-03T04:00:00Z 2003 6 2003-05-29T04:00:00Z 2003-08-28T03:59:59Z 2015-05-27T15:40:23Z   0 0 09000064805aed28
FDA-1981-N-0015-0006 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Advance Notice of Proposed Rule from FDA/CDER re Oral Health Care Drug Products for Over-the-Counter Human Use Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2003-06-03T04:00:00Z 2003 6 2003-05-29T04:00:00Z 2003-08-28T03:59:59Z 2015-05-27T15:42:27Z   0 0 09000064805aed29
FDA-1981-N-0015-0007 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Advance Notice of Proposed Rulemaking FDA/CDER re Oral Health Care Drug Products for Over-the-Counter Human Use; Antigingivitis/Antiplaque Drug Products; Establishment of a Monograph Proposed Rule Advance Notice of Proposed Rulemaking (ANPRM) 2003-06-03T04:00:00Z 2003 6 2003-05-29T04:00:00Z 2003-08-28T03:59:59Z 2015-06-09T18:29:40Z   0 0 09000064805aed2a
FDA-1981-N-0015-0001 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Over-the-Counter Dental and Oral Health Care Drug Products for Antiplaque Use; Safety and Efficacy Review; Request for Data and Information Notice Requests for Information (RFI) 1995-05-02T04:00:00Z 1995 5 1995-05-02T04:00:00Z 1991-03-19T04:59:59Z 2023-03-31T12:55:51Z   0 0 09000064805aecdc
FDA-1981-N-0015-0004 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Notice of Extension from FDA/CDER re over the couter dental and oral health care drug products for antiplaque use safty and efficacy review extension of submission period Notice Notice of Extension 1995-05-02T04:00:00Z 1995 5 1995-05-02T04:00:00Z 1991-06-18T03:59:59Z 2015-06-09T18:22:26Z   0 0 09000064805aecfa
FDA-1981-N-0015-0003 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Notice of Extension from FDA CDER re Over the counter dental and oral health care drug products for antiplaque use safty and efficacy review extension of submission period Notice Notice of Extension 1995-05-02T04:00:00Z 1995 5 1995-05-02T04:00:00Z 1991-06-18T03:59:59Z 2015-05-27T16:23:27Z   0 0 09000064805aecf9
FDA-1981-N-0015-0002 FDA Antigingivitis & Antiplaque-Related Claims FDA-1981-N-0015 Over-the-Counter Dental and Oral Health Care Drug Products for Antiplaque Use; Safety and Efficacy Review; Request for Data and Information Notice Requests for Information (RFI) 1995-05-02T04:00:00Z 1995 5 1995-05-02T04:00:00Z 1991-03-19T04:59:59Z 2023-03-31T12:56:48Z   0 0 09000064805aece2

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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);