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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

17 rows where docket_id = "FDA-2010-P-0188" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, withdrawn, posted_date (date), comment_start_date (date), last_modified (date)

posted_year 3

  • 2010 15
  • 2012 1
  • 2013 1

document_type 2

  • Supporting & Related Material 12
  • Other 5

agency_id 1

  • FDA 17
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-P-0188-0017 FDA None FDA-2010-P-0188 Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Withdrawal Other   2013-05-23T00:00:00Z 2013 5     2013-06-12T14:44:59Z   0 1 090000648105dbd9
FDA-2010-P-0188-0016 FDA None FDA-2010-P-0188 AXIN, Veltrop & Harkrider LLP (Actavis Elizabeth LLC) - Withdrawal of Citizen Petition Other Withdrawal 2012-12-31T05:00:00Z 2012 12 2012-12-31T05:00:00Z   2012-12-31T17:34:48Z   0 0 09000064811a0997
FDA-2010-P-0188-0015 FDA None FDA-2010-P-0188 Interim response to AXIN, Veltrop & Harkrider LLP (Actavis Elizabeth LLC) Other LET-Letter 2010-10-07T04:00:00Z 2010 10 2010-10-07T04:00:00Z   2013-07-27T23:34:03Z   0 0 0900006480b6a316
FDA-2010-P-0188-0005 FDA None FDA-2010-P-0188 Exhibit H - "U.S. Reissue Patent No. RE41,148" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:22:55Z   0 0 0900006480ad2c93
FDA-2010-P-0188-0012 FDA None FDA-2010-P-0188 Exhibit P - "FDA Letter to Buc & Beardsley, re Metformin, June 1, 2004" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:23:05Z   0 0 0900006480ad2cb8
FDA-2010-P-0188-0001 FDA None FDA-2010-P-0188 AXIN, Veltrop & Harkrider LLP (Actavis Elizabeth LLC) - Citizen Petition Other CP-Citizen Petition 2010-04-08T04:00:00Z 2010 4 2010-04-08T04:00:00Z   2013-07-27T23:15:07Z   0 0 0900006480ad2be2
FDA-2010-P-0188-0008 FDA None FDA-2010-P-0188 Exhibit L - "FDA Letter to Andrx Pharmacuetical, Inc., re Omeprazole, November 16, 2001" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:22:59Z   0 0 0900006480ad2cb4
FDA-2010-P-0188-0011 FDA None FDA-2010-P-0188 Exhibit O - "FDA Letter to Sandoz, Inc., re Ribavirin, April 6, 2004" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:23:03Z   0 0 0900006480ad2cb7
FDA-2010-P-0188-0003 FDA None FDA-2010-P-0188 Exhibit F - "Prosecution History of the 148 Patent" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:22:52Z   0 0 0900006480ad2c5e
FDA-2010-P-0188-0007 FDA None FDA-2010-P-0188 Exhibit K - "FDA Response to CP Docket No. 99P-1271 (APP Petition (PSA1), May 6, 1999)" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:22:58Z   0 0 0900006480ad2cb2
FDA-2010-P-0188-0010 FDA None FDA-2010-P-0188 Exhibit N - "FDA Letter to Apotex Corporation, re Paroxetine, July 30, 2003" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:23:02Z   0 0 0900006480ad2cb6
FDA-2010-P-0188-0013 FDA None FDA-2010-P-0188 Exhibit Q - "United States Court of Appeals, District of Columbia, Decision, No. 04-5046 (Dec. 17, 2004) - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:23:06Z   0 0 0900006480ad2cb9
FDA-2010-P-0188-0002 FDA None FDA-2010-P-0188 Exhibit A - "U.S. Patent No. 6,605,300" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:22:51Z   0 0 0900006480ad2be3
FDA-2010-P-0188-0006 FDA None FDA-2010-P-0188 Exhibit I - "Orange Book Listing for Adderall XR" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:22:56Z   0 0 0900006480ad2c94
FDA-2010-P-0188-0009 FDA None FDA-2010-P-0188 Exhibit M - "FDA Letter to American Pharmaceutical Partners, Inc., re Calcitrol Injection, February 4, 2003" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:23:01Z   0 0 0900006480ad2cb5
FDA-2010-P-0188-0004 FDA None FDA-2010-P-0188 Exhibit G - "Prosecution History of the 300 Patent" - [Actavis Elizabeth LLC (Axinn, Veltrop & Harkrider LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-04-08T04:00:00Z 2010 4     2010-04-08T21:22:53Z   0 0 0900006480ad2c90
FDA-2010-P-0188-0014 FDA None FDA-2010-P-0188 Acknowledgement Letter to AXIN, Veltrop & Harkrider LLP (Actavis Elizabeth LLC) Other ACK-Acknowledgement Letter 2010-04-08T04:00:00Z 2010 4 2010-04-08T04:00:00Z   2013-08-11T04:39:02Z   0 0 0900006480ad3255

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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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