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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

16 rows where docket_id = "FDA-2008-P-0343" sorted by posted_date descending

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

posted_year 2

  • 2008 12
  • 2009 4

document_type 2

  • Other 9
  • Supporting & Related Material 7

agency_id 1

  • FDA 16
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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
FDA-2008-P-0343-0013 FDA None FDA-2008-P-0343 Acknowledgement Letter to Novo Nordisk Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-07-27T22:34:25Z   0 0 09000064807f8d4b
FDA-2008-P-0343-0011 FDA None FDA-2008-P-0343 Acknowledgement Letter to Novo Nordisk Inc. Other ACK-Acknowledgement Letter 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2013-08-11T04:30:35Z   0 0 09000064807f915e
FDA-2008-P-0343-0012 FDA None FDA-2008-P-0343 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 09000064807f9130
FDA-2008-P-0343-0010 FDA None FDA-2008-P-0343 Novo Nordisk Inc. - Petition for Reconsideration Other PRC-Petition for Reconsideration 2008-12-31T05:00:00Z 2008 12 2008-12-31T05:00:00Z   2009-06-18T16:43:05Z   0 0 09000064807f8ce8
FDA-2008-P-0343-0009 FDA None FDA-2008-P-0343 FDA/CDER to Novo Nordisk, Inc. - Petition Denial Other PDN-Petition Denial 2008-12-04T05:00:00Z 2008 12 2008-12-04T05:00:00Z   2008-12-20T16:04:31Z   0 0 09000064807cd390
FDA-2008-P-0343-0008 FDA None FDA-2008-P-0343 Exhibit 2 - Product Description [Prandin] re FDA-2008-P-0343-0001 - Labeling Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-08-11T04:00:00Z 2008 8     2009-01-23T15:08:29Z   0 0 090000648062327f
FDA-2008-P-0343-0006 FDA None FDA-2008-P-0343 Novo Nordisk, Inc. [FDA-2008-P-0343-0001/CP] - Supplement Other SUP-Supplement 2008-07-24T04:00:00Z 2008 7 2008-07-24T04:00:00Z   2024-11-12T04:19:19Z   1 0 090000648068fb66
FDA-2008-P-0343-0005 FDA None FDA-2008-P-0343 Exhibit 1A - [FDA-2008-P-0343-0001] Silvio E. Inzucchi, M.D., Curriculum Vitae Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-06-18T04:00:00Z 2008 6     2008-08-11T18:42:14Z   0 0 090000648062c215
FDA-2008-P-0343-0002 FDA None FDA-2008-P-0343 Exhibit 1 - [FDA-2008-P-0343-0001 ] Declaration of Silvio E. Inzucchi, M.D. Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-06-17T04:00:00Z 2008 6     2008-08-11T18:38:36Z   0 0 0900006480623274
FDA-2008-P-0343-0003 FDA None FDA-2008-P-0343 Exhibit 3 - [FDA-2008-P-0343-0001] Product Description [Actos] Labeling Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-06-17T04:00:00Z 2008 6     2008-08-11T18:39:43Z   0 0 090000648062328e
FDA-2008-P-0343-0004 FDA None FDA-2008-P-0343 Acknowledgement Letter to Novo Nordisk Inc. Other ACK-Acknowledgement Letter 2008-06-17T04:00:00Z 2008 6 2008-06-17T04:00:00Z   2008-11-17T18:07:47Z   0 0 090000648061d366
FDA-2008-P-0343-0001 FDA None FDA-2008-P-0343 Novo Nordisk Inc. - Citizen Petition Other CP-Citizen Petition 2008-06-17T04:00:00Z 2008 6 2008-06-17T04:00:00Z   2008-12-04T20:41:29Z   0 0 090000648061d2c5

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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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