home / openregs

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

6 rows where docket_id = "FDA-2015-P-5108" and posted_year = 2016 sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: subtype, posted_date, posted_month, last_modified, posted_date (date), comment_start_date (date), last_modified (date)

document_type 2

  • Supporting & Related Material 4
  • Other 2

posted_year 1

  • 2016 · 6 ✖

agency_id 1

  • FDA 6
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options:

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;
Powered by Datasette · Queries took 1736.043ms · Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API