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withdrawn,object_id FDA-2015-P-5108-0017,FDA,FDA-2015-P-5108,Supplement from Purdue Pharma L.P.,Other,Supplement (SUP),2016-12-22T05:00:00Z,2016,12,2016-12-22T05:00:00Z,,2016-12-22T20:50:48Z,,0,0,0900006481e9eae4 FDA-2015-P-5108-0012,FDA,FDA-2015-P-5108,Final Agency Decision Petition Denial,Other,Denial of Petition,2016-05-20T04:00:00Z,2016,5,2016-05-20T04:00:00Z,,2016-05-20T17:31:10Z,,0,0,0900006481fe4be3 FDA-2015-P-5108-0014,FDA,FDA-2015-P-5108,"Exhibit 8 Physicians Desk Reference, 53rd Ed. 1999 Label for Roxicodone IR 5 mg re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2016-05-20T04:00:00Z,2016,5,,,2016-05-20T17:32:40Z,,0,0,0900006481dd778a FDA-2015-P-5108-0016,FDA,FDA-2015-P-5108,"Exhibit 3 Published Reports of Kaplan et al (1998), Heiskanen and Kalso (1997) and Bruera et al (1998) re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2016-05-20T04:00:00Z,2016,5,,,2016-05-20T17:32:40Z,,0,0,0900006481dd73da FDA-2015-P-5108-0015,FDA,FDA-2015-P-5108,"Exhibit 7 Kirvela, et al., The Pharmacokinetics of Oxycodone in Uremic Patients Undergoing Renal Transplantation re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2016-05-20T04:00:00Z,2016,5,,,2016-05-20T17:32:40Z,,0,0,0900006481dd7785 FDA-2015-P-5108-0013,FDA,FDA-2015-P-5108,"Exhibit 10 Gandelman, K et al. Single and Multiple Dose Study to Evaluate Pharmacokinetics Safety and Tolerability in Healthy Volunteers re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2016-05-20T04:00:00Z,2016,5,,,2016-05-20T17:32:39Z,,0,0,0900006481dd91ac