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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

11 rows where docket_id = "FDA-2013-N-0500" and posted_year = 2014 sorted by posted_date descending

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

document_type 2

  • Other 8
  • Supporting & Related Material 3

posted_year 1

  • 2014 · 11 ✖

agency_id 1

  • FDA 11
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2013-N-0500-0080 FDA None FDA-2013-N-0500 Memorandum of Meeting with GPhA (September 8, 2014) Other Memorandum 2014-12-17T05:00:00Z 2014 12 2014-12-17T05:00:00Z   2014-12-19T20:58:41Z   0 0 090000648197f44a
FDA-2013-N-0500-0079 FDA None FDA-2013-N-0500 Supplement from the Generic Pharmaceutical Association Other Supplement (SUP) 2014-07-18T04:00:00Z 2014 7 2014-07-18T04:00:00Z   2014-07-18T13:56:52Z   0 0 0900006481775a8b
FDA-2013-N-0500-0078 FDA None FDA-2013-N-0500 Attachment 3 Revised Virilon Package Insert with Changes Highlighted Supplement from Star Pharmaceuticals, Inc. Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-06-16T20:38:52Z   0 0 090000648171fbc5
FDA-2013-N-0500-0075 FDA None FDA-2013-N-0500 Supplement from Star Pharmaceuticals, Inc. Other Supplement (SUP) 2014-06-05T04:00:00Z 2014 6 2014-06-05T04:00:00Z   2014-06-05T19:03:19Z   0 0 090000648171fd33
FDA-2013-N-0500-0077 FDA None FDA-2013-N-0500 Attachment 2 Revised Virilon Package Insert re Supplement from Star Pharmaceuticals, Inc. Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-10-24T19:16:16Z   0 0 090000648171fbc4
FDA-2013-N-0500-0076 FDA None FDA-2013-N-0500 Attachment 1 Virilon Drug Listing re Supplement from Star Pharmaceuticals, Inc. Supporting & Related Material Background Material 2014-06-05T04:00:00Z 2014 6     2014-10-24T19:15:34Z   0 0 090000648171fad3
FDA-2013-N-0500-0010 FDA None FDA-2013-N-0500 Request for Extension from Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) Other Request for Extension 2014-02-10T05:00:00Z 2014 2 2014-02-10T05:00:00Z   2016-10-31T13:21:42Z   0 0 09000064814c6d0a
FDA-2013-N-0500-0009 FDA None FDA-2013-N-0500 Request for Extension from Mylan Other Request for Extension 2014-02-10T05:00:00Z 2014 2 2014-02-10T05:00:00Z   2016-10-31T13:21:42Z   0 0 09000064814c5e12
FDA-2013-N-0500-0011 FDA None FDA-2013-N-0500 Request for Extension from Perrigo Other Request for Extension 2014-02-10T05:00:00Z 2014 2 2014-02-10T05:00:00Z   2016-10-31T13:21:44Z   0 0 09000064814ca396
FDA-2013-N-0500-0008 FDA None FDA-2013-N-0500 Request for Extension from Academy of Managed Care Pharmacy (AMCP) et al Other Request for Extension 2014-02-10T05:00:00Z 2014 2     2016-10-31T13:21:41Z   0 0 09000064814c4f5c
FDA-2013-N-0500-0007 FDA None FDA-2013-N-0500 Request for Extension from Perrigo Other Request for Extension 2014-02-10T05:00:00Z 2014 2 2014-02-10T05:00:00Z   2016-10-31T13:21:40Z   0 0 09000064814b4789

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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;
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