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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

30 rows where docket_id = "FDA-1997-N-0041" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, last_modified, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

posted_year 4

  • 2009 26
  • 1997 2
  • 2000 1
  • 2001 1

document_type 2

  • Other 26
  • Notice 4

agency_id 1

  • FDA 30
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1997-N-0041-0022 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Acknowledgement Letter to Jerome Stevens Pharamceuticals Other ACK-Acknowledgement Letter 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:45Z   0 0 09000064805cfc2c
FDA-1997-N-0041-0016 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company - Supplement (SUP3) Other SUP-Supplement 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-28T01:52:42Z   0 0 09000064805cfc25
FDA-1997-N-0041-0017 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company - Supplement (SUP4) Other SUP-Supplement 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:38Z   0 0 09000064805cfc26
FDA-1997-N-0041-0014 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company to FDA - Letter Other LET-Letter 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:10Z   0 0 09000064805cfc1e
FDA-1997-N-0041-0010 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company - Supplement (SUP1) Other SUP-Supplement 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:10Z   0 0 09000064805cfc19
FDA-1997-N-0041-0009 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 FDA Interim Response to Mason, Taylor & Colicchio - Letter Other LET-Letter 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:27Z   0 0 09000064805cfc11
FDA-1997-N-0041-0031 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 FDA Response to Knoll Pharmaceutical, Inc. - Answer Other ANS-Answer 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:09Z   0 0 09000064805cfc06
FDA-1997-N-0041-0019 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company to FDA - Letter Other LET-Letter 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:10Z   0 0 09000064805cfc29
FDA-1997-N-0041-0015 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company - Supplement (SUP2) Other SUP-Supplement 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-08-11T02:52:27Z   0 0 09000064805cfc22
FDA-1997-N-0041-0005 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company [Buc & Beardsley] to FDA/CDER September 24, 1997 - Letter Other LET-Letter 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:09Z   0 0 09000064805cfc04
FDA-1997-N-0041-0026 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 FDA Response to Mason, Taylor & Colicchio - Petition Denial (PDN3) Other PDN-Petition Denial 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:10Z   0 0 09000064805cfc3a
FDA-1997-N-0041-0025 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 FDA Response to Knoll Pharmaceutical Company - Petition Denial (PDN2) Other PDN-Petition Denial 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:49Z   0 0 09000064805cfc39
FDA-1997-N-0041-0023 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company - Supplement (SUP5) Other SUP-Supplement 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-08-11T02:52:27Z   0 0 09000064805cfc32
FDA-1997-N-0041-0024 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 FDA Response to Jerome Stevens Pharmaceutical - Petition Denial (PDN1) Other PDN-Petition Denial 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:48Z   0 0 09000064805cfc38
FDA-1997-N-0041-0012 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company - Citizen Petition (CP3) Other CP-Citizen Petition 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:31Z   0 0 09000064805cfc1c
FDA-1997-N-0041-0011 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Jones Medical Industries (King & Spading) to FDA/CDER, June 12, 1998 - Letter Other LET-Letter 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-08-11T04:24:36Z   0 0 09000064805cfc1b
FDA-1997-N-0041-0008 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Acknowledgement Letter to Knoll Pharmaceutical Company Other ACK-Acknowledgement Letter 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:26Z   0 0 09000064805cfc09
FDA-1997-N-0041-0020 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company to FDA - Letter Other LET-Letter 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:10Z   0 0 09000064805cfc2a
FDA-1997-N-0041-0018 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 FDA Response to Knoll Pharmaceutical Company - Petition Approval Other PAV-Petition Approval 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:10Z   0 0 09000064805cfc28
FDA-1997-N-0041-0021 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Jerome Stevens Pharmaceuticals Inc., (Reed Smith LLP) - Citzen Petition (CP4) Other CP-Citizen Petition 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:44Z   0 0 09000064805cfc2b
FDA-1997-N-0041-0013 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Acknowledgement Letter to Knoll Pharmaceutical Company Other ACK-Acknowledgement Letter 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:33Z   0 0 09000064805cfc1d
FDA-1997-N-0041-0007 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Knoll Pharmaceutical Company - Citizen Petition (CP2) Other CP-Citizen Petition 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:24Z   0 0 09000064805cfc08
FDA-1997-N-0041-0032 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 FDA/CDER Response to Nancy L Buc [Buc & Beardsley] - Answer Other ANS-Answer 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:10Z   0 0 09000064805cfc20
FDA-1997-N-0041-0027 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Guidance for Industry on Levothyroxine Sodium Products-Enforcement of August 14, 2001, Compliance Date and Submission of New Applications; Guidance Document Other GDL-Guidance (Supporting and Related Materials) 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-28T01:52:42Z   0 0 09000064805cfc47
FDA-1997-N-0041-0033 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 FDA/CDER Response to Patton Boggs - Answer Other ANS-Answer 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2013-07-27T22:09:10Z   0 0 09000064805cfc40
FDA-1997-N-0041-0006 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Mason, Taylor & Colicchio - Citizen Petition (CP1) Other CP-Citizen Petition 2009-01-24T05:00:00Z 2009 1 2009-01-24T05:00:00Z   2009-01-25T01:36:23Z   0 0 09000064805cfc05
FDA-1997-N-0041-0004 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Guidance for Industry on Levothyroxine Sodium Products-Enforcement of August 14, 2001, Compliance Date and Submission of New Applications; Availability Notice NAD-Notice of Availability of Data 2001-07-18T04:00:00Z 2001 7     2009-01-24T19:59:15Z   0 0 09000064805cfc48
FDA-1997-N-0041-0003 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Prescription Drug Products; Levothyroxine Sodium; Extension of Compliance Date Notice N-Notice 2000-04-26T04:00:00Z 2000 4     2009-01-24T19:56:57Z   0 0 09000064805cfc27
FDA-1997-N-0041-0001 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Prescription Drug Products; Levothyroxine Sodium Notice N-Notice 1997-08-20T04:00:00Z 1997 8 1997-08-20T04:00:00Z 1997-10-15T03:59:59Z 2009-01-24T19:53:02Z   0 0 09000064805cfc01
FDA-1997-N-0041-0002 FDA Prescription Drug Products; Levothyroxine Sodium FDA-1997-N-0041 Prescription Drug Products; Levothyroxine Sodium [re FDA-1997-N-0041-0001 Notice N-Notice 1997-08-20T04:00:00Z 1997 8 1997-08-20T04:00:00Z 1997-10-15T03:59:59Z 2009-01-24T19:55:06Z   0 0 09000064805cfc03

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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;
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