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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

13 rows where agency_id = "FDA" and docket_id = "FDA-2007-P-0182" sorted by posted_date descending

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posted_year 4

document_type 2

agency_id 1

  • FDA · 13 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2007-P-0182-0017 FDA None FDA-2007-P-0182 FDA/CDER to sanofi-aventis U.S. LLC - Petition Partial Approval and Denial Other PPAD-Petition Partial Approval and Denial 2010-10-13T04:00:00Z 2010 10 2010-10-13T04:00:00Z   2013-08-11T01:37:34Z   0 0 0900006480b6e5df
FDA-2007-P-0182-0016 FDA None FDA-2007-P-0182 See FDA-2007P-0182-0017 Other   2010-10-13T00:00:00Z 2010 10     2013-07-27T23:34:29Z   0 1 0900006480b6e4c1
FDA-2007-P-0182-0014 FDA None FDA-2007-P-0182 See 2007-P-0182-0003 Other CP-Citizen Petition 2009-08-17T04:00:00Z 2009 8 2009-08-17T04:00:00Z   2009-08-26T17:07:15Z   0 0 0900006480a0b5fd
FDA-2007-P-0182-0011 FDA None FDA-2007-P-0182 sanofi-aventis - Supplement Other SUP-Supplement 2008-10-07T04:00:00Z 2008 10 2008-10-07T04:00:00Z   2008-10-07T21:43:20Z   0 0 09000064806b5573
FDA-2007-P-0182-0005 FDA None FDA-2007-P-0182 Sanofi Aventis U.S. Inc. - Appendix A - Excerpt for Relative bioavailability study Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-05-06T04:00:00Z 2008 5     2008-05-06T18:01:28Z   0 0 090000648054c420
FDA-2007-P-0182-0003 FDA None FDA-2007-P-0182 sanofi aventis - Citizen Petition Other CP-Citizen Petition 2008-05-06T04:00:00Z 2008 5 2008-05-06T04:00:00Z   2008-08-08T21:53:51Z   0 0 090000648054c41d
FDA-2007-P-0182-0006 FDA None FDA-2007-P-0182 Sanofi Aventis U.S. Inc. - Detailed Statement re Abrika's Opinion Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-05-06T04:00:00Z 2008 5     2008-05-06T18:01:29Z   0 0 090000648054c423
FDA-2007-P-0182-0008 FDA None FDA-2007-P-0182 Sanofi Aventis U.S. Inc. - Reference Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-05-06T04:00:00Z 2008 5     2008-05-06T18:01:30Z   0 0 090000648054c426
FDA-2007-P-0182-0007 FDA None FDA-2007-P-0182 Sanofi Aventis U.S. Inc. - Appendix B - Excerpt from bioavailability study Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-05-06T04:00:00Z 2008 5     2008-05-06T18:01:30Z   0 0 090000648054c425
FDA-2007-P-0182-0004 FDA None FDA-2007-P-0182 Sanofi Aventis U.S. Inc. - Reference - Detailed Basis for BARs Paragraph IV Certification Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-05-06T04:00:00Z 2008 5     2008-05-06T18:01:27Z   0 0 090000648054c41e
FDA-2007-P-0182-0009 FDA None FDA-2007-P-0182 Sanofi Aventis U.S. Inc. - References - Published Materials Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-05-06T04:00:00Z 2008 5     2008-05-06T18:01:31Z   0 0 090000648054c462
FDA-2007-P-0182-0002 FDA None FDA-2007-P-0182 FDA Center for Drug and Evaluation Research Response to Sanofi Aventis - Letter Other LET-Letter 2007-12-04T05:00:00Z 2007 12     2008-07-15T23:43:46Z   0 0 090000648042a706
FDA-2007-P-0182-0001 FDA None FDA-2007-P-0182 Acknowledgement Letter to Sanofi Aventis U.S. Inc. Other ACK-Acknowledgement Letter 2007-06-08T04:00:00Z 2007 6     2008-07-15T23:31:55Z   0 0 090000648042a6f7

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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;