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withdrawn,object_id FDA-2006-P-0025-0017,FDA,FDA-2006-P-0025,FDA/CDER Response to Sanofi Aventis US LLC - Petition Denial,Other,PDN-Petition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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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