documents

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

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35 rows where docket_id = "FDA-1975-N-0017" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1975-N-0017-0085 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Supplement from J. B. Williams Company, Inc. Other Supplement (SUP) 2011-03-17T04:00:00Z 2011 3 2011-03-17T04:00:00Z   2017-12-29T15:49:49Z   0 0 09000064805c2379
FDA-1975-N-0017-0083 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Letter from FDA/Bureau of Drugs to The J. B. Williams Company, Inc. Other Letter(s) 2011-02-28T05:00:00Z 2011 2 2011-02-28T05:00:00Z   2018-01-26T19:16:39Z   0 0 09000064805c23af
FDA-1975-N-0017-0077 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Block Drug Company, Inc. Other Objection(s) 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2018-01-02T18:04:01Z   0 0 09000064805c22f4
FDA-1975-N-0017-0079 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Eli Lilly & Company Other Objection(s) 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2018-01-02T17:52:35Z   0 0 09000064805c22fa
FDA-1975-N-0017-0074 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Center for Science In The Public Interest Other Objection(s) 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2018-01-02T18:11:55Z   0 0 09000064805c22ee
FDA-1975-N-0017-0076 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Pepsico, Inc. Other Objection(s) 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2018-01-02T18:06:26Z   0 0 09000064805c22f2
FDA-1975-N-0017-0081 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Citizen Action, California Citizen Action Group Other Objection(s) 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2018-01-02T17:07:48Z   0 0 09000064805c22fd
FDA-1975-N-0017-0073 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Miles Laboratories, Inc. Other Objection(s) 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2017-12-29T20:37:14Z   0 0 09000064805c22ec
FDA-1975-N-0017-0080 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Request for Hearing from The J. B. Williams Company, Inc. Other Objection(s) 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2018-01-02T17:12:32Z   0 0 09000064805c22fb
FDA-1975-N-0017-0082 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Bristol-Myers Products Other Objection(s) 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2018-01-02T16:58:39Z   0 0 09000064805c22ff
FDA-1975-N-0017-0078 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Correction from Center for Science in the Public Interest Other Correction(s) 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2018-01-02T18:00:52Z   0 0 09000064805c22f6
FDA-1975-N-0017-0075 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Request for Hearing from Feed Good Vitamin Corporation Other Request for Hearing 2011-02-18T05:00:00Z 2011 2 2011-02-18T05:00:00Z   2018-01-02T18:08:21Z   0 0 09000064805c22f0
FDA-1975-N-0017-0061 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Study No. S-2162-B re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis) Supporting & Related Material Background Material 2011-02-17T05:00:00Z 2011 2     2017-12-19T16:04:09Z   0 0 09000064805c22d6
FDA-1975-N-0017-0062 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 On The Purported Carcinogenesis of Methapyrilene re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis) Supporting & Related Material Background Material 2011-02-17T05:00:00Z 2011 2     2018-01-02T14:53:12Z   0 0 09000064805c22d7
FDA-1975-N-0017-0063 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Exhibit C- Letter to FDA DDM June 13, 1977 re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis) Supporting & Related Material Background Material 2011-02-17T05:00:00Z 2011 2     2018-01-02T14:53:48Z   0 0 09000064805c22da
FDA-1975-N-0017-0072 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Schering-Plough Corporation Other Objection(s) 2011-02-17T05:00:00Z 2011 2 2011-02-17T05:00:00Z   2017-12-29T20:41:59Z   0 0 09000064805c22ea
FDA-1975-N-0017-0066 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Consumer Action Other Objection(s) 2011-02-17T05:00:00Z 2011 2 2011-02-17T05:00:00Z   2018-01-02T13:35:35Z   0 0 09000064805c22dd
FDA-1975-N-0017-0059 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis) Other Request for Hearing 2011-02-17T05:00:00Z 2011 2 2011-02-17T05:00:00Z   2018-01-02T13:41:02Z   0 0 09000064805c22d4
FDA-1975-N-0017-0065 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Exhibit E - Report on Studies Supporting the Safety and Efficacy of Dipehnhydramine as a Nighttime Sleep-Aid re: Request for Hearing from Bristol Myers Company Supporting & Related Material Background Material 2011-02-17T05:00:00Z 2011 2     2018-01-29T14:51:17Z   0 0 09000064805c22dc
FDA-1975-N-0017-0070 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Request for Hearing from Block Drug Company, Inc. Other Request for Hearing 2011-02-17T05:00:00Z 2011 2 2011-02-17T05:00:00Z   2018-01-02T12:55:24Z   0 0 09000064805c22e6
FDA-1975-N-0017-0069 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Blair Laboratories, Inc. Other Objection(s) 2011-02-17T05:00:00Z 2011 2 2011-02-17T05:00:00Z   2018-01-02T13:22:38Z   0 0 09000064805c22e3
FDA-1975-N-0017-0064 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Exhibit D - Letter from Health and Welfare Canada to Mrs. N.D. Moore (July 18, 1978) re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis) Supporting & Related Material Background Material 2011-02-17T05:00:00Z 2011 2     2018-01-02T14:53:58Z   0 0 09000064805c22db
FDA-1975-N-0017-0060 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 W-2080 Hypnotic Activity of Diphenhydramine, Methapyrilene, and Placebo re: Request for Hearing from Bristol Myers Company (Weil, Guttman & Davis) Supporting & Related Material Background Material 2011-02-17T05:00:00Z 2011 2     2018-01-02T15:06:38Z   0 0 09000064805c22d5
FDA-1975-N-0017-0071 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Request for Hearing from The Proprietary Association Other Request for Hearing 2011-02-17T05:00:00Z 2011 2 2011-02-17T05:00:00Z   2017-12-29T20:44:40Z   0 0 09000064805c22e8
FDA-1975-N-0017-0067 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Center for Science In The Public Interest Other Objection(s) 2011-02-17T05:00:00Z 2011 2 2011-02-17T05:00:00Z   2018-01-02T13:31:54Z   0 0 09000064805c22de
FDA-1975-N-0017-0068 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Objection from Children's Hospital Medical Center Other Objection(s) 2011-02-17T05:00:00Z 2011 2 2011-02-17T05:00:00Z   2018-01-02T13:27:50Z   0 0 09000064805c22e1
FDA-1975-N-0017-0055 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Proposal To Establish Monographs For OTC Nighttime Sleep-Aid, Daytime Sedative, And Stimulant Products (Part 1) Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-02-07T05:00:00Z 2011 2 2011-02-07T05:00:00Z 1976-03-09T04:59:59Z 2018-01-24T21:03:21Z 75-32774 0 0 09000064805c22a6
FDA-1975-N-0017-0058 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Memorandum of Telephone Conversation between Weil, Guttman & Davis and FDA Other Memorandum 2011-02-07T05:00:00Z 2011 2 2011-02-07T05:00:00Z   2017-11-27T14:03:50Z   0 0 09000064805c22ab
FDA-1975-N-0017-0057 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Proposal To Establish Monographs For OTC Nighttime Sleep-Aid, Daytime Sedative, And Stimulant Products; Correction Notice   2011-02-07T00:00:00Z 2011 2     2023-11-03T14:47:22Z   0 1 09000064805c22a9
FDA-1975-N-0017-0052 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Supplement from McNeil Consumer Healthcare (Response to Request for Information) Other Supplement (SUP) 2010-08-13T04:00:00Z 2010 8 2010-08-13T04:00:00Z   2018-01-30T14:59:35Z   0 0 0900006480b2f0ce
FDA-1975-N-0017-0053 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 New Clinical Data on Acetaminophen/Diphenhydramine Combination Products as a Nighttime Sleep-Aid Drug Product for OTC Use re McNeil Consumer Healthcare - Comment, FDA-1975-N-0017-0051 Supporting & Related Material C-Comment (Supporting and Related Material) 2010-08-13T04:00:00Z 2010 8     2013-04-12T15:56:31Z   0 0 0900006480b2ffbf
FDA-1975-N-0017-0054 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Table of Contents - Study Numbers... Combination of OTC Nighttime Sleep-Aid and OTC Internal Analgesic(s): Data Supporting Category 1 Designation - [McNeil Consumer Healthcare (Response to Request for Information) - Supplement] re FDA-1975-N-0017-0052 re: Supplement from McNeil Consumer Healthcare (Response to Request for Information) Supporting & Related Material Studies and Reports 2010-08-13T04:00:00Z 2010 8     2018-01-05T14:58:01Z   0 0 0900006480b2f0cf
FDA-1975-N-0017-0050 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 See FDA-1975-N-0017-0028 Rule NFR-Notice of Final Rule 2010-04-09T04:00:00Z 2010 4 2010-04-09T04:00:00Z   2011-02-08T14:46:37Z   0 0 0900006480ad3b5e
FDA-1975-N-0017-0049 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 FDA/CDER to Consumer Healthcare Products Association - Response Letter Other LET-Letter 2010-02-17T05:00:00Z 2010 2 2010-02-17T05:00:00Z   2013-08-11T03:06:52Z   0 0 0900006480aa6a63
FDA-1975-N-0017-0047 FDA OTC Nighttime Sleep-Aid, Daytime Sedative, & Stimulant Products-CLOSED FDA-1975-N-0017 Protocol Review from Nonprescription Drug Manufacturers Association Other Protocol Review 2010-01-21T05:00:00Z 2010 1 2010-01-21T05:00:00Z   2018-01-02T18:08:41Z   0 0 09000064805c2428

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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);