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

4 rows where docket_id = "FDA-2008-P-0343" and posted_year = 2009 sorted by posted_date descending

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

document_type 2

posted_year 1

  • 2009 · 4 ✖

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2008-P-0343-0024 FDA None FDA-2008-P-0343 FDA Office of Policy to Novo Nordisk, Inc. - Petition Reconsideration & Petition for Stay of Action Denial Other PDN-Petition Denial 2009-06-18T04:00:00Z 2009 6 2009-06-18T04:00:00Z   2013-07-27T22:47:20Z   0 0 09000064809d2325
FDA-2008-P-0343-0022 FDA None FDA-2008-P-0343 Exhibit 2 - "Winston & Strawn LLP (on behalf of Caraco) to FDA/CDER, re: request for Correction, June 1, 2009" - [Caraco Pharmaceuticals Laboratories, LTD - (Winston & Strawn LLP) - Reply Comment] re FDA-2008-P-0343-0020 Supporting & Related Material RC-Reply Comment (Supporting and Related Material) 2009-06-17T04:00:00Z 2009 6     2009-06-18T00:17:05Z   0 0 09000064809d01f3
FDA-2008-P-0343-0021 FDA None FDA-2008-P-0343 Exhibit 1 - "Caraco Letter to FDA/CDER , re: ANDA 77-571/Repaglinide, May 29, 2009" - [Caraco Pharmaceuticals Laboratories, LTD - (Winston & Strawn LLP) - Reply Comment] re FDA-2008-P-0343-0020 Supporting & Related Material RC-Reply Comment (Supporting and Related Material) 2009-06-17T04:00:00Z 2009 6     2009-06-18T00:16:47Z   0 0 09000064809d0622
FDA-2008-P-0343-0023 FDA None FDA-2008-P-0343 Exhibit 3 - "Caraco's Motion and Brief in Support of Motion Requesting Leave to Supplement Answer and CounterClaims, Civil Action No. 2:05 CV 40188" - [Caraco Pharmaceuticals Laboratories, LTD - (Winston & Strawn LLP) - Reply Comment] re FDA-2008-P-0343-0020 Supporting & Related Material RC-Reply Comment (Supporting and Related Material) 2009-06-17T04:00:00Z 2009 6     2009-06-18T00:15:48Z   0 0 09000064809d01f5

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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;