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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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16 rows where docket_id = "FDA-2015-P-5108" 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-P-5108-0017 FDA None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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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;