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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-2005-E-0311" 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

  • 2005 3
  • 2006 2
  • 2007 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2005-E-0311-0007 FDA Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498 FDA-2005-E-0311 Certificate Extending Patent Term from U.S. Patent and Trademark Office to OSI Pharmaceuticals, Inc. Rule Certificate Extending Patent Term 2007-10-17T04:00:00Z 2007 10     2025-12-03T10:00:20Z   0 0 0900006480447827
FDA-2005-E-0311-0006 FDA Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498 FDA-2005-E-0311 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2007-05-14T04:00:00Z 2007 5     2025-12-03T00:36:31Z   0 0 090000648044781e
FDA-2005-E-0311-0005 FDA Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498 FDA-2005-E-0311 Determination of Regulatory Review Period for Purposes of Patent Extension; TARCEVA Notice General Notice 2006-09-29T04:00:00Z 2006 9 2006-09-29T04:00:00Z   2025-12-03T00:32:04Z E6-15987 0 0 090000648044781c
FDA-2005-E-0311-0004 FDA Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498 FDA-2005-E-0311 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2006-09-11T04:00:00Z 2006 9     2025-12-03T00:28:49Z   0 0 0900006480447819
FDA-2005-E-0311-0003 FDA Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498 FDA-2005-E-0311 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2005-07-18T04:00:00Z 2005 7     2025-12-03T00:14:12Z   0 0 0900006480447816
FDA-2005-E-0311-0002 FDA Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498 FDA-2005-E-0311 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2005-07-15T04:00:00Z 2005 7     2025-12-03T00:12:38Z   0 0 0900006480447814
FDA-2005-E-0311-0001 FDA Patent Extension Application for TARCEVA (erlotinib hydrochloride), U.S. Patent No. 5,747,498 FDA-2005-E-0311 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2005-06-22T04:00:00Z 2005 6     2025-12-03T00:10:21Z   0 0 09000064804477c9

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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);
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