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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-2009-P-0581" sorted by posted_date descending

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

posted_year 3

  • 2009 15
  • 2010 1
  • 2013 1

document_type 2

  • Supporting & Related Material 13
  • Other 4

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2009-P-0581-0019 FDA None FDA-2009-P-0581 FDA/CVM Correspondence to the Division of Dockets Management re Bayer HealthCare LLC (Ropes & Gray, LLP) - Electronic Letter Other Letter(s) 2013-12-03T05:00:00Z 2013 12 2013-12-03T05:00:00Z   2013-12-03T19:24:47Z   0 0 090000648149db95
FDA-2009-P-0581-0018 FDA None FDA-2009-P-0581 FDA/CVM Interim Resonse to Ropes & Gray LLP - Letter Other LET-Letter 2010-06-16T04:00:00Z 2010 6 2010-06-16T04:00:00Z   2013-12-03T18:16:10Z   0 0 0900006480b02771
FDA-2009-P-0581-0008 FDA None FDA-2009-P-0581 Exhibit G - "Norbrook Letter to FDA/CVM, re: Amendment to ANADA 200-495 - NORFLOXIN 100 (enrofloxacin) and Patent Certification, December 1, 2008" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:19Z   0 0 0900006480a63612
FDA-2009-P-0581-0007 FDA None FDA-2009-P-0581 Exhibit F - "Hogan & Hartson Letter to Williams & Connolly LLP, December 4, 2008 (re: Bayer v. Norbrook (District of Kansas, Eastern District of Wisconsin)" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:18Z   0 0 0900006480a63611
FDA-2009-P-0581-0002 FDA None FDA-2009-P-0581 Exhibit A - "United States Patent, 5,756,506, Copeland et al., Single High Dose Fluoroquinolone Treatment" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:11Z   0 0 0900006480a6350b
FDA-2009-P-0581-0014 FDA None FDA-2009-P-0581 Exhibit M - "House Report" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:27Z   0 0 0900006480a63697
FDA-2009-P-0581-0012 FDA None FDA-2009-P-0581 Exhibit K - "Bayer HealthCare Animal Health Letter to FDA/CVM, April 17, 2009" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:24Z   0 0 0900006480a63618
FDA-2009-P-0581-0015 FDA None FDA-2009-P-0581 Acknowledgement Letter to Bayer HealthCare LLC (Ropes & Gray, LLP) Other ACK-Acknowledgement Letter 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2013-08-11T04:36:50Z   0 0 0900006480a6357c
FDA-2009-P-0581-0011 FDA None FDA-2009-P-0581 Exhibit J - "District of Kansas, Eastern District of Wisconsin, Norbrook Labs and Norbrook, Inc. USA, Second Amended Answer and Counterclaims to Plaintiffs's Complaint" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:23Z   0 0 0900006480a63615
FDA-2009-P-0581-0006 FDA None FDA-2009-P-0581 Exhibit E - "United States District Court Eastern District of Wisconsin Milwaukee Division, Bayer HealthCare vs. Norbrook Labs., Complaint" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:16Z   0 0 0900006480a63511
FDA-2009-P-0581-0009 FDA None FDA-2009-P-0581 Exhibit H - "Bayer HealthCare vs. Norbrook Labs. Decision and Order" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:20Z   0 0 0900006480a63613
FDA-2009-P-0581-0004 FDA None FDA-2009-P-0581 Exhibit C - "Signature Proof of Delivery" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:14Z   0 0 0900006480a6350d
FDA-2009-P-0581-0003 FDA None FDA-2009-P-0581 Exhibit B - "Norbrook Labs. Ltd. Letter to Bayer USA Corporate Communications, July 14, 2008" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:12Z   0 0 0900006480a6350c
FDA-2009-P-0581-0005 FDA None FDA-2009-P-0581 Exhibit D - "Bayer HealthCare, LLC Email re Confirmation Receipt, October 3, 2008" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:15Z   0 0 0900006480a6350e
FDA-2009-P-0581-0010 FDA None FDA-2009-P-0581 Exhibit I - "District of Kansas, Eastern District of Wisconsin, Norbrook Labs' Reply Memorandum of Law in Support of Its Motion for Judgment on the Pleadings" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:22Z   0 0 0900006480a63614
FDA-2009-P-0581-0001 FDA None FDA-2009-P-0581 Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition Other CP-Citizen Petition 2009-12-09T05:00:00Z 2009 12 2009-12-09T05:00:00Z   2013-12-08T02:21:43Z   0 0 0900006480a63509
FDA-2009-P-0581-0013 FDA None FDA-2009-P-0581 Exhibit L - "District of Kansas, Eastern District of Wisconsin, Norbrook Labs and Norbrook, Inc. USA, Memorandum of Law in Support of Its Motion for Judgment on the Pleadings" - [Bayer HealthCare LLC (Ropes & Gray, LLP) - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2009-12-09T05:00:00Z 2009 12     2009-12-10T03:24:26Z   0 0 0900006480a63619

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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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