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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

7 rows where docket_id = "FDA-2003-E-0114" sorted by posted_date descending

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

posted_year 3

  • 2004 4
  • 2003 2
  • 2006 1

document_type 3

  • Other 5
  • Notice 1
  • Rule 1

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-E-0114-0007 FDA Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353 FDA-2003-E-0114 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Novartis Rule Certificate Extending Patent Term 2006-09-15T04:00:00Z 2006 9     2025-10-31T09:00:07Z   0 0 0900006480485158
FDA-2003-E-0114-0006 FDA Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353 FDA-2003-E-0114 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2004-10-21T04:00:00Z 2004 10     2025-10-30T16:49:08Z   0 0 0900006480485155
FDA-2003-E-0114-0005 FDA Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353 FDA-2003-E-0114 Determination of Regulatory Review Period for Purposes of Patent Extension; ZELNORM Notice General Notice 2004-03-16T05:00:00Z 2004 3 2004-03-15T05:00:00Z   2025-10-30T16:47:12Z 04-5758 0 0 0900006480485153
FDA-2003-E-0114-0004 FDA Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353 FDA-2003-E-0114 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2004-03-05T05:00:00Z 2004 3     2025-10-30T16:36:57Z   0 0 0900006480485151
FDA-2003-E-0114-0003 FDA Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353 FDA-2003-E-0114 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2004-01-16T05:00:00Z 2004 1     2025-10-30T16:34:51Z   0 0 090000648048514e
FDA-2003-E-0114-0002 FDA Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353 FDA-2003-E-0114 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2003-11-24T05:00:00Z 2003 11     2025-10-30T16:30:11Z   0 0 090000648048514c
FDA-2003-E-0114-0001 FDA Zelnorm (Tegaserod Maleate), Patent Term Extension Application, U.S. Patent No. 5,510,353 FDA-2003-E-0114 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2003-09-04T04:00:00Z 2003 9     2025-10-30T16:28:21Z   0 0 09000064804850f4

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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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