documents

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

36 rows where docket_id = "FDA-1978-N-0021" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1978-N-0021-0042 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 FDA/CDER Maalox Total Relief Memo Meeting minutes and Quarterly Reports 12 9 11 Other Report 2011-12-27T05:00:00Z 2011 12 2011-12-27T05:00:00Z   2011-12-27T13:50:45Z   0 0 0900006480f899cc
FDA-1978-N-0021-0040 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Letter from C.B. Fleet Company, Inc. Other Letter(s) 2011-02-14T05:00:00Z 2011 2 2011-02-14T05:00:00Z   2016-09-13T15:20:59Z   0 0 0900006480bc8d4a
FDA-1978-N-0021-0038 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 XI. List of References 1 - 43 - [1978-N-0021 formerly Docket 1978N-0036L] Supporting & Related Material Background Material 2011-02-11T05:00:00Z 2011 2     2016-09-26T14:11:16Z   0 0 0900006480bebd6c
FDA-1978-N-0021-0039 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Reference 1 - FDA-2007-P-0345.0031 - [ XI. References 1 - 43 - FDA-1978-N-0021 (formerly Docket 1978N-0036L) - List] Supporting & Related Material Background Material 2011-02-11T05:00:00Z 2011 2     2016-09-26T14:11:29Z   0 0 0900006480bebdd0
FDA-1978-N-0021-0037 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Notice of Proposed Rulemaking re Professional Labeling for Laxative Drug Products for Over-the-Counter Human Use: Amendment to Tentative Final Monograph Proposed Rule Notice of Proposed Rulemaking (NPRM) 2011-02-11T05:00:00Z 2011 2 2011-02-11T05:00:00Z 2011-03-15T03:59:59Z 2016-08-22T20:55:33Z 2011-3091 0 0 0900006480becd42
FDA-1978-N-0021-0034 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Attachment 2 - FDA Alert (12/11/2008) [FDA-1978-N-0021-0032] Supporting & Related Material LET-Letter (Supporting and Related Material) 2010-12-29T05:00:00Z 2010 12     2010-12-29T19:21:54Z   0 0 0900006480bc2184
FDA-1978-N-0021-0035 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Attachment 3 - FDA Alert (5/2006) [FDA-1978-N-0021-0032] Supporting & Related Material BKG-Background Material 2010-12-29T05:00:00Z 2010 12     2010-12-29T19:30:50Z   0 0 0900006480bc2187
FDA-1978-N-0021-0033 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Attachment 1 - Letter to Peter S. Reichertz, Esq [FDA-1978-N-0021-0032] Supporting & Related Material LET-Letter (Supporting and Related Material) 2010-12-29T05:00:00Z 2010 12     2010-12-29T19:16:08Z   0 0 0900006480bc2182
FDA-1978-N-0021-0032 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Letter from FDA/CDER to Peter S. Reichertz, Esq. and Christopher A. Brown, Esq. Other LET-Letter 2010-12-29T05:00:00Z 2010 12 2010-12-29T05:00:00Z   2016-09-13T15:18:53Z   0 0 0900006480bc2181
FDA-1978-N-0021-0036 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Attachment 4 - Science Backgrounder: Safethy of Sodium Phosphates Oral Solution [FDA-1978-N-0021-0032] Supporting & Related Material LET-Letter (Supporting and Related Material) 2010-12-29T05:00:00Z 2010 12     2010-12-29T19:35:46Z   0 0 0900006480bc226a
FDA-1978-N-0021-0029 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 C. B. Fleet Company, Inc. - Supplement to Citizen Petition of March 23, 1993 Other Supplement (SUP) 2008-12-11T05:00:00Z 2008 12 2008-12-11T05:00:00Z   2016-09-15T19:25:51Z   0 0 090000648055d1e8
FDA-1978-N-0021-0031 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 FDA to Peter S. Reichertz, Esq. and Christopher A. Brown, Esq. - Petition Denied Other PDN-Petition Denial 2008-12-11T05:00:00Z 2008 12 2008-12-11T05:00:00Z   2008-12-22T18:06:25Z   0 0 09000064807d803a
FDA-1978-N-0021-0030 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Citizen Petition from C.B. Fleet Company Other Citizen Petition 2008-12-11T05:00:00Z 2008 12 2008-12-11T05:00:00Z   2016-09-22T17:33:54Z   0 0 090000648055d60d
FDA-1978-N-0021-0028 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Transmittal sheet re letter from FDA/CDER to The Purdue Frederick Company Supporting & Related Material Transmittals 2006-10-04T04:00:00Z 2006 10     2016-08-16T18:04:51Z   0 0 090000648055d752
FDA-1978-N-0021-0027 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Letter from FDA/CDER to The Purdue Frederick Company Other Letter(s) 2006-10-04T04:00:00Z 2006 10     2016-08-16T18:02:23Z   0 0 090000648055d750
FDA-1978-N-0021-0024 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Petition approval from FDA/Office of the Commissioner to The Purdue Frederick Company Other Approval 2005-01-07T05:00:00Z 2005 1     2016-09-21T15:20:42Z   0 0 090000648055d73d
FDA-1978-N-0021-0023 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Petition approval from FDA/Office of the Commissioner to Sonnenschein, Nath & Rosenthal, LLP Other Approval 2004-10-12T04:00:00Z 2004 10     2016-09-21T15:20:31Z   0 0 090000648055d73c
FDA-1978-N-0021-0022 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Acknowledgement Letter from FDA/DDM to Sonnenschein, Nath & Rosenthal, LLP Other Acknowledgement Letter/Receipt 2004-05-20T04:00:00Z 2004 5     2016-09-21T15:24:25Z   0 0 090000648055d73a
FDA-1978-N-0021-0021 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Acknowledgement Letter from FDA/DDM to Sonnenschein, Nath & Rosenthal, LLP Other Acknowledgement Letter/Receipt 2004-05-20T04:00:00Z 2004 5     2016-09-21T15:23:39Z   0 0 090000648055d738
FDA-1978-N-0021-0020 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Acknowledgement Letter from FDA/DDM to The Purdue Frederick Company Other Acknowledgement Letter/Receipt 2004-04-13T04:00:00Z 2004 4     2016-09-21T15:48:55Z   0 0 090000648055d729
FDA-1978-N-0021-0019 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Acknowledgement Letter from FDA/DDM to The Purdue Frederick Company Other Acknowledgement Letter/Receipt 2004-04-13T04:00:00Z 2004 4     2016-08-10T20:19:03Z   0 0 090000648055d728
FDA-1978-N-0021-0018 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Letter from FDA/CDER to Sonnenschein, Nath & Rosenthal Other Letter(s) 2004-01-06T05:00:00Z 2004 1     2016-09-19T20:40:02Z   0 0 090000648055d6a5
FDA-1978-N-0021-0017 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Acknowledgment letter from FDA/CDER to C.I.B.A. Consumer Pharmaceuticals Other Acknowledgement Letter/Receipt 2003-12-10T05:00:00Z 2003 12     2016-09-16T13:25:45Z   0 0 090000648055d699
FDA-1978-N-0021-0015 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Petition Denial from FDA/Office of the Commissioner to Banner Pharmacaps, Inc. Other Denial of Petition 2003-11-19T05:00:00Z 2003 11     2016-08-09T18:36:38Z   0 0 090000648055d687
FDA-1978-N-0021-0016 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Petition Denial from FDA/Office of the Commissioner to Banner Pharmacaps, Inc. Other Denial of Petition 2003-11-19T05:00:00Z 2003 11     2016-09-19T20:46:15Z   0 0 090000648055d696
FDA-1978-N-0021-0014 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Notice of Proposed Rulemaking re Laxative Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record Proposed Rule Notice of Proposed Rulemaking (NPRM) 2003-10-23T04:00:00Z 2003 10 2003-10-22T04:00:00Z 2004-01-21T04:59:59Z 2016-08-09T20:43:30Z   0 0 090000648055d669
FDA-1978-N-0021-0013 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Letter from FDA/CDER to The Purdue Frederick Company Other Letter(s) 2003-10-22T04:00:00Z 2003 10     2016-09-21T15:00:19Z   0 0 090000648055d666
FDA-1978-N-0021-0012 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Petition Denial from FDA/Office of the Commissioner to The Purdue Frederick Company Other Denial of Petition 2003-09-17T04:00:00Z 2003 9     2016-09-21T15:00:53Z   0 0 090000648055d662
FDA-1978-N-0021-0010 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Petition Denial from FDA/Office of the Commissioner to Arnall Golden Gregory, LLP Other Denial of Petition 2003-09-10T04:00:00Z 2003 9     2016-09-21T15:01:29Z   0 0 090000648055d648
FDA-1978-N-0021-0011 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Letter from FDA/CDER Other Letter(s) 2003-09-10T04:00:00Z 2003 9     2016-09-21T15:51:39Z   0 0 090000648055d64b
FDA-1978-N-0021-0009 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Petition Denial from FDA/Office of the Commissioner to American Herbal Products Association-International Aloe Science Council Other Denial of Petition 2003-07-25T04:00:00Z 2003 7     2016-09-21T15:56:34Z   0 0 090000648055d631
FDA-1978-N-0021-0008 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Final Rule; Status of Certain Additional Over-the-Counter Drug Category II and Ill Active Ingredients Rule Final Rule 2002-05-10T04:00:00Z 2002 5     2016-08-03T20:09:29Z   0 0 090000648055d5e4
FDA-1978-N-0021-0007 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Notice of Proposed Rulemaking- Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph Proposed Rule Notice of Proposed Rulemaking (NPRM) 1998-06-23T04:00:00Z 1998 6 1998-06-23T04:00:00Z 1998-09-18T03:59:59Z 2016-09-22T14:17:32Z   0 0 090000648055d3ce
FDA-1978-N-0021-0004 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Tab B: Supporting & related materials Supporting & Related Material Background Material 1994-04-07T04:00:00Z 1994 4     2016-09-16T16:55:56Z   0 0 090000648055d115
FDA-1978-N-0021-0006 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Tab A: Products complaints and published materials Supporting & Related Material Background Material 1994-04-07T04:00:00Z 1994 4     2016-09-16T16:55:21Z   0 0 090000648055d11d
FDA-1978-N-0021-0005 FDA Over-the-Counter (OTC) Laxative FDA-1978-N-0021 Notice of Proposed Rulemaking -Laxative Drug Products For Over-The-Counter Human Use; Proposed Amendment To The Tentative Final Monograph Proposed Rule Notice of Proposed Rulemaking (NPRM) 1994-04-07T04:00:00Z 1994 4 1994-04-07T04:00:00Z 1994-06-01T03:59:59Z 2016-08-03T19:58:19Z   0 0 090000648055d119

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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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;