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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

16 rows where docket_id = "FDA-1997-P-0065" sorted by posted_date descending

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posted_year 2

  • 2009 15
  • 1998 1

document_type 2

  • Other 15
  • Notice 1

agency_id 1

  • FDA 16
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-0065-0002 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Pharmanex, Inc. - Petition for Stay Other PSA-Petition for Stay 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2009-01-08T01:45:26Z   0 0 09000064805d0371
FDA-1997-P-0065-0003 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Acknowledgement Letter to Pharmanex, Inc. Other ACK-Acknowledgement Letter 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2013-07-28T01:52:43Z   0 0 09000064805d0372
FDA-1997-P-0065-0010 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Pharmanex, Inc., to the Food and Drug Administration - Letter Other LET-Letter 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2009-01-08T01:45:38Z   0 0 09000064805d0479
FDA-1997-P-0065-0013 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Pharmanex, LLC - Petition for Reconsideration Other PRC-Petition for Reconsideration 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2013-07-28T01:52:44Z   0 0 09000064805d04b5
FDA-1997-P-0065-0014 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Acknowledgement Letter to Pharmanex, Inc. Other ACK-Acknowledgement Letter 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2013-07-27T22:09:16Z   0 0 09000064805d04b6
FDA-1997-P-0065-0004 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 FDA/CFSAN Interim Response to Pharmanex, Inc. - Letter Other LET-Letter 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2009-01-08T01:45:30Z   0 0 09000064805d0374
FDA-1997-P-0065-0007 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Meeting Between FDA and Pharmanex, Inc., April 7, 1997 - Memorandum of Meeting Other MM-Memorandum of Meeting 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2009-01-08T01:45:34Z   0 0 09000064805d041d
FDA-1997-P-0065-0012 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Record of Telephone Conversation between FDA and Pharmanex Inc. - Memorandum Other MT-Memorandum of Telephone Conversation 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2009-01-08T01:45:41Z   0 0 09000064805d04a5
FDA-1997-P-0065-0005 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Office of the Chief Counsel Response to Covington & Burling - Answer Other ANS-Answer 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2013-08-11T02:52:29Z   0 0 09000064805d037c
FDA-1997-P-0065-0015 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Pharmanex, Inc. - Petition for Stay Supplement Other SUP-Supplement 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2009-01-08T01:45:45Z   0 0 09000064808128fc
FDA-1997-P-0065-0011 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Pharmanex, Inc., to the Food and Drug Administration - Letter Other LET-Letter 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2013-07-28T01:52:44Z   0 0 09000064805d047a
FDA-1997-P-0065-0016 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 FDA/CFSAN Response to Pharmanex Inc - Answer Other CP-Citizen Petition 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2013-07-27T22:09:16Z   0 0 09000064805d04a4
FDA-1997-P-0065-0008 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Pharmanex, Inc. to the Food and Drug Administration - Letter Other LET-Letter 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2013-07-27T22:09:15Z   0 0 09000064805d042a
FDA-1997-P-0065-0009 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Pharmanex, Inc. - Petition Supplement Other SUP-Supplement 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2013-07-27T22:09:16Z   0 0 09000064805d0474
FDA-1997-P-0065-0006 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Pharmanex, Inc. - Correction Other CR-Correction 2009-01-07T05:00:00Z 2009 1 2009-01-07T05:00:00Z   2013-07-27T22:09:15Z   0 0 09000064805d0413
FDA-1997-P-0065-0001 FDA Regulatory Status of Cholestin Red Yeast Rice FDA-1997-P-0065 Administrative Proceeding; Re: Pharmanex, Inc. Notice N-Notice 1998-01-16T05:00:00Z 1998 1 1998-01-16T05:00:00Z 1998-01-31T04:59:59Z 2009-01-08T01:42:41Z   0 0 09000064805d035f

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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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