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withdrawn,object_id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
FDA-2015-P-5108-0002,FDA,FDA-2015-P-5108,"Acknowledgement Letter from FDA DDM to Kleinfeld, Kaplan and Becker, LLP",Other,Acknowledgement Letter/Receipt,2015-12-31T05:00:00Z,2015,12,2015-12-31T05:00:00Z,,2015-12-31T19:22:42Z,,0,0,0900006481ddf501
FDA-2015-P-5108-0003,FDA,FDA-2015-P-5108,"Exhibit 1 Physicians Desk Reference, 53rd Ed. 1999 Label for Percodan re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2015-12-31T05:00:00Z,2015,12,,,2015-12-31T19:24:16Z,,0,0,0900006481dd73d8
FDA-2015-P-5108-0009,FDA,FDA-2015-P-5108,"Exhibit 11 Benziger, Cheng, Miotto,  and Grandy  Comparative Pharmacokinetics of Controlled Release Oxycodone (OxyContin) in special populations re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2015-12-31T05:00:00Z,2015,12,,,2015-12-31T19:42:08Z,,0,0,0900006481dd91ad
FDA-2015-P-5108-0004,FDA,FDA-2015-P-5108,"Exhibit 2 Physicians Desk Reference, 53rd Ed. 1999 Label for OxyContin re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2015-12-31T05:00:00Z,2015,12,,,2015-12-31T19:25:19Z,,0,0,0900006481dd73d9
FDA-2015-P-5108-0005,FDA,FDA-2015-P-5108,"Exhibit 4 Medical Officer Review, Integrated Summary of Efficacy, Oxycodone Controlled Release, NDA 20553 and Medical officer Review, OxyContin Study 0402B-Cancer Pain re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2015-12-31T05:00:00Z,2015,12,,,2015-12-31T19:28:13Z,,0,0,0900006481dd73db
FDA-2015-P-5108-0010,FDA,FDA-2015-P-5108,"Exhibit 12 Kaiko, Grandy, Hou, and Benziger Controlled Release Oxycodone Pharmacokinetics Pharmacodynamics in Hepatic Cirrhosis (Abstract) re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2015-12-31T05:00:00Z,2015,12,,,2015-12-31T19:47:34Z,,0,0,0900006481dd91ae
FDA-2015-P-5108-0006,FDA,FDA-2015-P-5108,"Exhibit 5 Exclusivity Summary, NDA 20553 re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2015-12-31T05:00:00Z,2015,12,,,2015-12-31T19:29:45Z,,0,0,0900006481dd7b86
FDA-2015-P-5108-0008,FDA,FDA-2015-P-5108,"Exhibit 9 Comments from Purdue Pharma L.P. Docket No. FDA-2011-N-0830 (June 8, 2015) re  Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2015-12-31T05:00:00Z,2015,12,,,2015-12-31T19:37:07Z,,0,0,0900006481dd91ab
FDA-2015-P-5108-0001,FDA,FDA-2015-P-5108,"Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Other,Citizen Petition,2015-12-31T05:00:00Z,2015,12,2015-12-31T05:00:00Z,,2024-11-11T21:19:54Z,,1,0,0900006481dd5e86
FDA-2015-P-5108-0007,FDA,FDA-2015-P-5108,"Exhibit 6 NDA Review, NDA 20-553 E.D. Bashaw, PharmD, with Excerpts from Appendix to Review
re Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP)",Supporting & Related Material,Background Material,2015-12-31T05:00:00Z,2015,12,,,2015-12-31T19:32:06Z,,0,0,0900006481dd7783