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

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38 rows where docket_id = "FDA-1992-N-0049" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1992-N-0049-0034 FDA Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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 Topical Drug Containing Benzoyl Peroxide; Additional Labeling 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

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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);