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

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

22 rows where agency_id = "FDA" and docket_id = "FDA-1977-N-0018" sorted by posted_date descending

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posted_year 8

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  • FDA · 22 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1977-N-0018-0101 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Citizen Petition Denial Response from FDA to Bayer Healthcare, LLC Other Denial 2014-05-02T04:00:00Z 2014 5 2014-05-02T04:00:00Z   2014-05-02T21:22:30Z   0 0 09000064816def57
FDA-1977-N-0018-0097 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Tab Attachment re: Supplement from Bayer Healthcare, LLC Supporting & Related Material Background Material 2014-05-02T04:00:00Z 2014 5     2019-02-05T16:24:08Z   0 0 09000064805d9b8b
FDA-1977-N-0018-0093 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Supplement from Bayer HealthCare LLC, Consumer Care Division Other Supplement (SUP) 2014-05-02T04:00:00Z 2014 5 2014-05-02T04:00:00Z   2019-02-01T14:49:41Z   0 0 09000064805d99b0
FDA-1977-N-0018-0100 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Memorandum of Meeting Between FDA/CDER and Bayer HealthCare dated April 30, 2014 Other Memorandum 2014-05-02T04:00:00Z 2014 5 2014-05-02T04:00:00Z   2019-01-29T17:24:51Z   0 0 09000064805d99c0
FDA-1977-N-0018-0095 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Supplement from Innovative Science Solutions, LLC Other Supplement (SUP) 2014-05-02T04:00:00Z 2014 5 2014-05-02T04:00:00Z   2019-02-05T17:39:06Z   0 0 09000064805d9b88
FDA-1977-N-0018-0094 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Supplement from Clinical Trial Service Unit & Epidemiological Studies Unit-University of Oxford Other Supplement (SUP) 2014-05-02T04:00:00Z 2014 5     2019-02-05T15:35:43Z   0 0 09000064805d9b80
FDA-1977-N-0018-0092 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Citizen Petition from Bayer Healthcare, LLC Other Citizen Petition 2014-05-02T04:00:00Z 2014 5 2014-05-02T04:00:00Z   2019-02-05T18:40:00Z   0 0 09000064805d9995
FDA-1977-N-0018-0098 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Supplement from University of Alabama at Birmingham (UAB) Other Supplement (SUP) 2014-05-02T04:00:00Z 2014 5 2014-05-02T04:00:00Z   2019-02-05T16:28:32Z   0 0 09000064805d9b8d
FDA-1977-N-0018-0096 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Supplement from Bayer Healthcare, LLC Other Supplement (SUP) 2014-05-02T04:00:00Z 2014 5 2014-05-02T04:00:00Z   2019-02-05T16:23:38Z   0 0 09000064805d9b8a
FDA-1977-N-0018-0091 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Drug Products for the Treatment and/or Prevention of Nocturnal Leg Muscle Cramps for Over-the-Counter Human Use; Final Rule Notice Notice of Final Rule 2012-12-19T05:00:00Z 2012 12 2012-12-19T05:00:00Z   2018-12-26T13:27:13Z 94-20449 0 0 09000064805d9854
FDA-1977-N-0018-0090 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Letter from Akin, Gump, Strauss, Hauer & Feld, L.L.P on behalf of PharmaControl Corporation (Pharmaceuticals Formulations Incorporated) to FDA CDER Other Letter(s) 2012-12-19T05:00:00Z 2012 12     2019-02-27T21:39:51Z   0 0 09000064805d9842
FDA-1977-N-0018-0084 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Joint Meeting of The Nonprecription Drug Advisory Committee and the Cardiovascular and Renal Drugs Advisory Committee - Transcript Other Transcript(s) 2011-02-16T05:00:00Z 2011 2 2011-02-16T05:00:00Z   2012-12-07T15:17:56Z   0 0 0900006480bf023e
FDA-1977-N-0018-0079 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Acknowledgment Letter from FDA/DDM to Dr. Brian Kaplan Other Acknowledgement Letter/Receipt 2007-05-29T04:00:00Z 2007 5     2019-02-05T17:23:36Z   0 0 09000064805d9b9a
FDA-1977-N-0018-0078 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Letter from FDA/CDER to Innovative Science Solutions, LLC Other Letter(s) 2005-05-17T04:00:00Z 2005 5     2019-02-05T16:10:31Z   0 0 09000064805d9b86
FDA-1977-N-0018-0062 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Answer from FDA to Letter from Mallard Inc. Other Answer 2004-08-10T04:00:00Z 2004 8     2018-12-21T14:13:12Z   0 0 09000064805d99c7
FDA-1977-N-0018-0056 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 FDA/CDER Other M-Memorandum 2004-04-28T04:00:00Z 2004 4     2010-04-08T15:52:21Z   0 0 09000064805d99bf
FDA-1977-N-0018-0055 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Memorandum between FDA and Bayer Health Care LLC Other Memorandum 2004-04-28T04:00:00Z 2004 4     2019-01-29T17:22:10Z   0 0 09000064805d99be
FDA-1977-N-0018-0054 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Memorandum of Meeting Between FDA/CDER and Bayer HealthCare dated November 19, 2003 Other Memorandum 2003-12-09T05:00:00Z 2003 12     2019-02-04T17:13:11Z   0 0 09000064805d99ab
FDA-1977-N-0018-0053 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Memorandum between Representatives of FDA and Bayer HealthCare, LLC Other Memorandum 2003-11-12T05:00:00Z 2003 11     2019-02-04T17:15:11Z   0 0 09000064805d99aa
FDA-1977-N-0018-0052 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Internal Memorandum from Charles J Ganley (HFD-560) to FDA/DDM (HFA-305) August 8 2003 Other Memorandum 2003-08-22T04:00:00Z 2003 8     2019-02-01T14:33:27Z   0 0 09000064805d99a3
FDA-1977-N-0018-0051 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Letter from FDA/CDER to Bayer HealthCare, LLC Other Letter(s) 2003-08-22T04:00:00Z 2003 8     2019-01-28T21:43:10Z   0 0 09000064805d99a2
FDA-1977-N-0018-0080 FDA Over-the-Counter Internal Analgesic, Antipyretic & Antirheumatic Products: OPEN FDA-1977-N-0018 Acknowledgment Letter from FDA DDM re: Citizen Petition from Whitehall-Robins Healthcare (A Division of American Home Products Corporation) (Volume 1 of 4) Other Acknowledgement Letter/Receipt 1997-11-28T05:00:00Z 1997 11     2019-02-05T13:16:24Z   0 0 09000064805d9b9d

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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);