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

3 rows where docket_id = "FDA-2006-P-0025" and posted_year = 2009 sorted by posted_date descending

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

document_type 2

posted_year 1

  • 2009 · 3 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2006-P-0025-0017 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 FDA/CDER Response to Sanofi Aventis US LLC - Petition Denial Other PDN-Petition Denial 2009-07-11T04:00:00Z 2009 7 2009-07-11T04:00:00Z   2009-07-11T09:05:04Z   0 0 09000064809eede3
FDA-2006-P-0025-0018 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 ICH Harmonised Tripartite Guidelines "Impurities in New Drug Products Q3B(R2)" - [Sanofi-aventis U.S., LLC (sanofi-aventis) - Petition Supplement(2)] Supporting & Related Material SUP-Supplement (Supporting and Related Material) 2009-07-11T04:00:00Z 2009 7     2009-07-11T09:15:59Z   0 0 0900006480971bb1
FDA-2006-P-0025-0016 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 Sanofi-aventis U.S., LLC (sanofi-aventis) - Petition Supplement(2) Other SUP-Supplement 2009-05-14T04:00:00Z 2009 5 2009-05-14T04:00:00Z   2013-08-11T01:27:14Z   0 0 090000648096ea74

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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    withdrawn INTEGER,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);