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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

5 rows where docket_id = "FDA-2015-N-1260" sorted by posted_date descending

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

document_type 3

  • Proposed Rule 2
  • Supporting & Related Material 2
  • Other 1

posted_year 2

  • 2015 3
  • 2016 2

agency_id 1

  • FDA 5
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-N-1260-0008 FDA None FDA-2015-N-1260 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period Proposed Rule Reopening of Comment Period 2016-04-18T04:00:00Z 2016 4 2016-04-18T04:00:00Z 2016-05-19T03:59:59Z 2016-05-18T22:00:30Z 2016-08888 0 0 0900006481f70598
FDA-2015-N-1260-0006 FDA None FDA-2015-N-1260 Request for Extension from BASF Corporation (Morgan Lewis) Other Request for Extension 2016-03-22T04:00:00Z 2016 3 2016-03-22T04:00:00Z   2016-03-22T13:41:13Z   0 0 0900006481ed33a5
FDA-2015-N-1260-0002 FDA None FDA-2015-N-1260 Reference 5 Letter to K. Irwin, President and CEO, Omni Neutraceuticals, Inc., from D. Horowitz, Acting Director, Office of Compliance, CDER, re ‘‘Inholtra Joint Pain Caplets and Inholtra Joint Pain Plus’’ (October 16, 2001). Supporting & Related Material Background Material 2015-12-23T05:00:00Z 2015 12     2015-12-23T21:57:20Z   0 0 0900006481dcf789
FDA-2015-N-1260-0001 FDA None FDA-2015-N-1260 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-12-23T05:00:00Z 2015 12 2015-12-23T05:00:00Z 2016-05-19T03:59:59Z 2016-05-12T11:47:00Z 2015-32246 0 0 0900006481dc97c5
FDA-2015-N-1260-0003 FDA None FDA-2015-N-1260 Reference 8: Food and Drug Administration, Full Disclosure of Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis on Regulations on Fixed-Combination and Co-packaged Drugs and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter (OTC) Monograph Proposed Rule. Supporting & Related Material Background Material 2015-12-23T05:00:00Z 2015 12     2015-12-23T22:00:12Z   0 0 0900006481dcf78a

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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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