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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

6 rows where docket_id = "FDA-2004-E-0268" sorted by posted_date descending

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

posted_year 3

  • 2004 2
  • 2005 2
  • 2006 2

document_type 3

  • Other 4
  • Notice 1
  • Rule 1

agency_id 1

  • FDA 6
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2004-E-0268-0004 FDA Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943 FDA-2004-E-0268 Certificate Extending Patent Term from U.S. Patent and Trademark Office to Birch, Stewart, Kolash & Birch, LLP Rule Certificate Extending Patent Term 2006-11-22T05:00:00Z 2006 11     2025-11-13T00:24:57Z   0 0 09000064804721ed
FDA-2004-E-0268-0003 FDA Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943 FDA-2004-E-0268 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2006-01-12T05:00:00Z 2006 1     2025-11-13T00:22:58Z   0 0 09000064804721ec
FDA-2004-E-0268-0002 FDA Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943 FDA-2004-E-0268 Determination of Regulatory Review Period for Purposes of Patent Extension; ERTACZO Notice General Notice 2005-05-19T04:00:00Z 2005 5 2005-05-12T04:00:00Z 2005-07-12T03:59:59Z 2025-11-13T00:20:22Z 05-9462 0 0 09000064804721eb
FDA-2004-E-0268-0006 FDA Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943 FDA-2004-E-0268 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2005-04-19T04:00:00Z 2005 4     2025-11-13T00:28:58Z   0 0 09000064804721ef
FDA-2004-E-0268-0005 FDA Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943 FDA-2004-E-0268 Letter from FDA CDER to U.S. Patent and Trademark Office Other Letter(s) 2004-09-02T04:00:00Z 2004 9     2025-11-13T00:27:06Z   0 0 09000064804721ee
FDA-2004-E-0268-0001 FDA Patent Extension for ERTACZO (sertaconazole nitrate), U.S. Patent No. 5,135,943 FDA-2004-E-0268 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2004-07-15T04:00:00Z 2004 7     2025-11-24T18:35:23Z   0 0 09000064804721e8

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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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