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

8 rows where docket_id = "FDA-2011-N-0830" and posted_year = 2015 sorted by posted_date descending

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

posted_year 1

  • 2015 · 8 ✖

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2011-N-0830-0008 FDA None FDA-2011-N-0830 Abbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period Proposed Rule Extension of Comment Period 2015-04-24T04:00:00Z 2015 4 2015-04-24T04:00:00Z 2015-06-09T03:59:59Z 2015-06-10T01:30:47Z 2015-09523 0 0 0900006481ab8547
FDA-2011-N-0830-0007 FDA None FDA-2011-N-0830 Request for Extension from Generic Pharmaceutical Association (GPhA) Other Request for Extension 2015-04-03T04:00:00Z 2015 4 2015-04-03T04:00:00Z   2015-04-03T14:28:29Z   0 0 0900006481a4313f
FDA-2011-N-0830-0006 FDA None FDA-2011-N-0830 Request for Extension from Teva Pharmaceuticals Other Request for Extension 2015-04-03T04:00:00Z 2015 4 2015-04-03T04:00:00Z   2015-04-03T14:19:47Z   0 0 0900006481a3f782
FDA-2011-N-0830-0005 FDA None FDA-2011-N-0830 Abbreviated New Drug Applications and 505(b)(2) Applications Proposed Rule Correction 2015-03-13T04:00:00Z 2015 3 2015-03-13T04:00:00Z   2015-03-13T16:28:12Z C1-2015-01666 0 0 0900006481a4296e
FDA-2011-N-0830-0004 FDA None FDA-2011-N-0830 Reference 2 - Pharmaceutical Preparation Manufacturing 2002, Economic Census Manufacturing Industry Series re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2015-02-06T05:00:00Z 2015 2     2015-02-06T16:37:42Z   0 0 09000064819f8606
FDA-2011-N-0830-0002 FDA None FDA-2011-N-0830 List of References re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2015-02-06T05:00:00Z 2015 2     2015-02-06T16:37:25Z   0 0 09000064819f8604
FDA-2011-N-0830-0001 FDA None FDA-2011-N-0830 Abbreviated New Drug Applications and 505(b)(2) Applications Proposed Rule Notice of Proposed Rulemaking (NPRM) 2015-02-06T05:00:00Z 2015 2 2015-02-06T05:00:00Z 2015-05-08T03:59:59Z 2015-04-10T02:06:25Z 2015-01666 0 0 09000064819f78d2
FDA-2011-N-0830-0003 FDA None FDA-2011-N-0830 Reference 1 - ANDAs and 505(b)(2) Applications Docket No. FDA-2011-N-0830 Preliminary Regulatory Impact Analysis Initial Regulatory Flexibility Analysis Unfunded Mandates Reform Act Analysis re Abbreviated New Drug Applications and 505(b)(2) Applications Supporting & Related Material Background Material 2015-02-06T05:00:00Z 2015 2     2015-02-06T16:37:36Z   0 0 09000064819f8605

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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;