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

18 rows where docket_id = "FDA-2006-P-0025" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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
FDA-2006-P-0025-0011 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 Sanofi-aventis US LLP - Appendix B - sanofi-aventis Analytical Study Report: Analytical Assessment of Oxaliplatin Solutions Containing Tartaric Acid Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-11-17T05:00:00Z 2008 11     2008-11-17T15:35:41Z   0 0 0900006480441f20
FDA-2006-P-0025-0007 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 Sanofi-aventis US LLP - Reference 32 - U.S. Patent No. 6,476,068 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-11-17T05:00:00Z 2008 11     2008-11-17T15:35:37Z   0 0 0900006480441f02
FDA-2006-P-0025-0009 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 Sanofi-aventis US LLP - Appendix A - Declarations of Professor Stephen Chaney Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-11-17T05:00:00Z 2008 11     2008-11-17T15:35:39Z   0 0 0900006480441f1c
FDA-2006-P-0025-0008 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 Sanofi-aventis US LLP - Reference 31 - U.S. Patent No. 6,673,805 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-11-17T05:00:00Z 2008 11     2008-11-17T15:35:38Z   0 0 0900006480441f03
FDA-2006-P-0025-0015 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 - Appendix B - Supplemental Declaration of Stephen G. Chaney, Ph.D. Supporting & Related Material SUP-Supplement (Supporting and Related Material) 2008-11-17T05:00:00Z 2008 11     2008-11-17T16:04:27Z   0 0 0900006480441f34
FDA-2006-P-0025-0005 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 Sanofi-aventis US LLP - Reference 34 Mayne Pharma. Pty. LTD, et al. U.S. Patent Application No. WO/2005/020980 A1 (filed Oct. 03, 2005). Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-11-17T05:00:00Z 2008 11     2008-11-17T15:35:34Z   0 0 0900006480441efc
FDA-2006-P-0025-0010 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 Sanofi-aventis US LLP - Appendix A - Declarations of Professor Nicholas Fartell Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-11-17T05:00:00Z 2008 11     2008-11-17T15:35:40Z   0 0 0900006480441f1f
FDA-2006-P-0025-0012 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 - Citizen Petition Supplement Other SUP-Supplement 2008-11-17T05:00:00Z 2008 11 2008-11-17T05:00:00Z   2008-11-17T16:03:59Z   0 0 0900006480441f35
FDA-2006-P-0025-0006 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 Sanofi-aventis US LLP - Reference 33 - U.S. Patent Application Publication No. US 2003/0109515 A1, Jun. 12, 2003 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-11-17T05:00:00Z 2008 11     2008-11-17T15:35:35Z   0 0 0900006480441efd
FDA-2006-P-0025-0004 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 Sanofi-aventis US LLP - Citizen Petition Other CP-Citizen Petition 2008-11-17T05:00:00Z 2008 11 2008-11-17T05:00:00Z   2009-07-11T09:01:35Z   0 0 0900006480441f1b
FDA-2006-P-0025-0014 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 - Appendix B - Supplemental Declaration of Nichola s P. Farrell, Ph.D. Supporting & Related Material SUP-Supplement (Supporting and Related Material) 2008-11-17T05:00:00Z 2008 11     2008-11-17T16:04:25Z   0 0 0900006480441f33
FDA-2006-P-0025-0013 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 - U.S. Patent Application 20070054957 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-11-17T05:00:00Z 2008 11     2008-11-17T16:04:24Z   0 0 0900006480441f25
FDA-2006-P-0025-0003 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 FDA/CDER to Sanofi Aventis US LLC Other LET-Letter 2007-06-25T04:00:00Z 2007 6     2008-04-11T23:17:23Z   0 0 0900006480441f36
FDA-2006-P-0025-0002 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 FDA/DDM to Sanofi-aventis US LLP Other ACK-Acknowledgement Letter 2006-12-19T05:00:00Z 2006 12     2008-04-11T23:17:24Z   0 0 0900006480441f21
FDA-2006-P-0025-0001 FDA Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 FDA/DDM to Sanofi-aventis US LLP Other ACK-Acknowledgement Letter 2006-12-19T05:00:00Z 2006 12     2008-04-11T23:17:24Z   0 0 0900006480441ef8

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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);