documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
12 rows where docket_id = "FDA-2006-P-0025" and posted_year = 2008 sorted by posted_date descending
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Suggested facets: subtype, posted_date (date), comment_start_date (date), last_modified (date)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2006-P-0025-0011 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis US LLP - Appendix B - sanofi-aventis Analytical Study Report: Analytical Assessment of Oxaliplatin Solutions Containing Tartaric Acid | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T15:35:41Z | 0 | 0 | 0900006480441f20 | |||
| FDA-2006-P-0025-0007 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis US LLP - Reference 32 - U.S. Patent No. 6,476,068 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T15:35:37Z | 0 | 0 | 0900006480441f02 | |||
| FDA-2006-P-0025-0009 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis US LLP - Appendix A - Declarations of Professor Stephen Chaney | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T15:35:39Z | 0 | 0 | 0900006480441f1c | |||
| FDA-2006-P-0025-0008 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis US LLP - Reference 31 - U.S. Patent No. 6,673,805 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T15:35:38Z | 0 | 0 | 0900006480441f03 | |||
| FDA-2006-P-0025-0015 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis U.S LLC - Appendix B - Supplemental Declaration of Stephen G. Chaney, Ph.D. | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T16:04:27Z | 0 | 0 | 0900006480441f34 | |||
| FDA-2006-P-0025-0005 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis US LLP - Reference 34 Mayne Pharma. Pty. LTD, et al. U.S. Patent Application No. WO/2005/020980 A1 (filed Oct. 03, 2005). | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T15:35:34Z | 0 | 0 | 0900006480441efc | |||
| FDA-2006-P-0025-0010 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis US LLP - Appendix A - Declarations of Professor Nicholas Fartell | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T15:35:40Z | 0 | 0 | 0900006480441f1f | |||
| FDA-2006-P-0025-0012 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis U.S LLC - Citizen Petition Supplement | Other | SUP-Supplement | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T05:00:00Z | 2008-11-17T16:03:59Z | 0 | 0 | 0900006480441f35 | ||
| FDA-2006-P-0025-0006 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis US LLP - Reference 33 - U.S. Patent Application Publication No. US 2003/0109515 A1, Jun. 12, 2003 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T15:35:35Z | 0 | 0 | 0900006480441efd | |||
| FDA-2006-P-0025-0004 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis US LLP - Citizen Petition | Other | CP-Citizen Petition | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T05:00:00Z | 2009-07-11T09:01:35Z | 0 | 0 | 0900006480441f1b | ||
| FDA-2006-P-0025-0014 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis U.S LLC - Appendix B - Supplemental Declaration of Nichola s P. Farrell, Ph.D. | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T16:04:25Z | 0 | 0 | 0900006480441f33 | |||
| FDA-2006-P-0025-0013 | FDA | Require ANDA Applicant for Generic of Eloxatin Solution as Reference Drug to Perform Clinical Testing-CLOSED FDA-2006-P-0025 | Sanofi-aventis U.S LLC - U.S. Patent Application 20070054957 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2008-11-17T05:00:00Z | 2008 | 11 | 2008-11-17T16:04:24Z | 0 | 0 | 0900006480441f25 |
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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);