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

12 rows where docket_id = "FDA-2008-P-0411" 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), last_modified (date)

posted_year 2

document_type 2

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0411-0021 FDA None FDA-2008-P-0411 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 09000064809d2328
FDA-2008-P-0411-0018 FDA None FDA-2008-P-0411 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-0411-0017 Supporting & Related Material RC-Reply Comment (Supporting and Related Material) 2009-06-17T04:00:00Z 2009 6     2009-06-18T00:15:06Z   0 0 09000064809d05f7
FDA-2008-P-0411-0020 FDA None FDA-2008-P-0411 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-0411-0017 Supporting & Related Material RC-Reply Comment (Supporting and Related Material) 2009-06-17T04:00:00Z 2009 6     2009-06-18T00:16:16Z   0 0 09000064809d05fc
FDA-2008-P-0411-0019 FDA None FDA-2008-P-0411 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-0411-0017 Supporting & Related Material RC-Reply Comment (Supporting and Related Material) 2009-06-17T04:00:00Z 2009 6     2009-06-18T00:15:29Z   0 0 09000064809d05fb
FDA-2008-P-0411-0009 FDA None FDA-2008-P-0411 Novo Nordisk Inc. - Petition for Stay of Action Other PSA-Petition for Stay 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-08-11T02:58:51Z   0 0 09000064807f9170
FDA-2008-P-0411-0007 FDA None FDA-2008-P-0411 Novo Nordisk Inc. - Petition for Reconsideration Other PRC-Petition for Reconsideration 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2009-06-18T16:54:55Z   0 0 09000064807f8de8
FDA-2008-P-0411-0010 FDA None FDA-2008-P-0411 Acknowledgement Letter to Novo Nordisk Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-28T01:58:06Z   0 0 09000064807f8e2e
FDA-2008-P-0411-0008 FDA None FDA-2008-P-0411 Acknowledgement Letter to Novo Nordisk Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-27T22:34:27Z   0 0 09000064807f919e
FDA-2008-P-0411-0006 FDA None FDA-2008-P-0411 FDA/CDER to Caraco Pharmaceuticals Laboratories, Ltd. (James F. Hurst) - Petition Approval Other PAV-Petition Approval 2008-12-04T05:00:00Z 2008 12 2008-12-04T05:00:00Z   2009-01-23T15:55:32Z   0 0 09000064807cd3e5
FDA-2008-P-0411-0003 FDA None FDA-2008-P-0411 Caraco Pharmaceutical Laboratories, Ltd - Amendment Other AMD-Amendment 2008-08-05T04:00:00Z 2008 8 2008-08-05T04:00:00Z   2013-07-27T22:20:54Z   0 0 09000064806af9aa
FDA-2008-P-0411-0002 FDA None FDA-2008-P-0411 Acknowledgement Letter to Caraco Pharmaceutical Laboratories, Ltd. Other ACK-Acknowledgement Letter 2008-07-20T04:00:00Z 2008 7 2008-07-20T04:00:00Z   2008-11-17T19:26:29Z   0 0 090000648067e39c
FDA-2008-P-0411-0001 FDA None FDA-2008-P-0411 Caraco Pharmaceutical Laboratories, Ltd. - Citizen Petition Other CP-Citizen Petition 2008-07-20T04:00:00Z 2008 7 2008-07-20T04:00:00Z   2009-05-01T21:55:41Z   0 0 090000648067e350

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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;