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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)
document_type 2
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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;