documents

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 agency_id = "FDA" and docket_id = "FDA-2004-P-0338" sorted by posted_date descending

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

posted_year 4

document_type 1

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-0338-0006 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 FDA-CDER to Valeant Pharmaceuticals International - Response Other PDN-Petition Denial 2009-08-07T04:00:00Z 2009 8 2009-08-07T04:00:00Z   2009-08-07T13:26:53Z   0 0 0900006480524706
FDA-2004-P-0338-0005 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 Ted Sherwood Other MM-Memorandum of Meeting 2007-11-20T05:00:00Z 2007 11     2008-04-12T00:49:25Z   0 0 0900006480473328
FDA-2004-P-0338-0003 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 HFD-5 to Valeant Pharmaceuticals International Other LET-Letter 2005-07-01T04:00:00Z 2005 7     2008-04-12T00:49:25Z   0 0 0900006480473300
FDA-2004-P-0338-0004 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 HFD-5 to Valeant Pharmaceuticals International Other LET-Letter 2005-07-01T04:00:00Z 2005 7     2008-04-12T00:49:25Z   0 0 0900006480473301
FDA-2004-P-0338-0001 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 HFA-305 to Valeant Pharmaceuticals International Other ACK-Acknowledgement Letter 2004-12-22T05:00:00Z 2004 12     2008-04-12T00:49:25Z   0 0 09000064804732f6
FDA-2004-P-0338-0002 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 HFA-305 to Valeant Pharmaceuticals International Other ACK-Acknowledgement Letter 2004-12-22T05:00:00Z 2004 12     2008-04-12T00:49:25Z   0 0 09000064804732ff

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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);