documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
15 rows where docket_id = "FDA-2005-P-0319" and posted_year = 2010 sorted by posted_date descending
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| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2005-P-0319-0017 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Luitpold Pharmaceuticals, Inc., (Sheppard Mullin Richter & Hampton, LLP) - Supplement | Other | SUP-Supplement | 2010-06-28T04:00:00Z | 2010 | 6 | 2010-06-28T04:00:00Z | 2013-07-27T23:22:59Z | 0 | 0 | 0900006480b08bc2 | ||
| FDA-2005-P-0319-0018 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Exhibit A - "Rottembourg, et al, [Su583] Do Two "Identical" Intravenous Iron Sucrose Preparations Have the Same Efficacy" - [Luitpold Pharmaceuticals, Inc., (Sheppard Mullin Richter & Hampton, LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2010-06-28T04:00:00Z | 2010 | 6 | 2010-06-28T23:35:15Z | 0 | 0 | 0900006480b08d25 | |||
| FDA-2005-P-0319-0016 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Luitpold Pharmaceuticals, Inc., (Sheppard Mullin Richter & Hampton, LLP) - Supplement | Other | SUP-Supplement | 2010-05-18T04:00:00Z | 2010 | 5 | 2010-05-18T04:00:00Z | 2012-01-06T12:25:44Z | 0 | 0 | 0900006480aeca43 | ||
| FDA-2005-P-0319-0011 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Luitpold Pharmaceuticals, Inc. - Supplement | Other | SUP-Supplement | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T04:00:00Z | 2010-05-14T18:06:47Z | 0 | 0 | 0900006480447e14 | ||
| FDA-2005-P-0319-0010 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Exhibit 17 - "Federal Register Vol. 65, No. 47, Thursday, March 9, 2000" - [Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal, LLP) - Citizen Petition] re FDA-2005-P-0319-0004 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T17:52:45Z | 0 | 0 | 0900006480447e06 | |||
| FDA-2005-P-0319-0004 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal, LLP) - Citizen Petition | Other | CP-Citizen Petition | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T04:00:00Z | 2025-08-08T18:36:23Z | 0 | 0 | 0900006480447dfe | ||
| FDA-2005-P-0319-0005 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Exhibit 1 - "Federal Register 33 No. 124, June 26, 1968" - [Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal, LLP) - Citizen Petition] re FDA-2005-P-0319-0004 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T17:09:13Z | 0 | 0 | 0900006480447dfd | |||
| FDA-2005-P-0319-0007 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Exhibit 8 - "Results of Analysis" - [Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal, LLP) - Citizen Petition] re FDA-2005-P-0319-0004 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T17:52:13Z | 0 | 0 | 0900006480447e04 | |||
| FDA-2005-P-0319-0009 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Exhibit 16 - "Ferrlecit - Intravenous Iron Substitution Therapy, November 16, 1995" - [Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal, LLP) - Citizen Petition] re FDA-2005-P-0319-0004 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T17:52:43Z | 0 | 0 | 0900006480447e05 | |||
| FDA-2005-P-0319-0012 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Attachment 1 - "Risks with Copy Products of Intravenous Iron Complex Preparations" - [Luitpold Pharmaceuticals, Inc. - Supplement] re FDA-2005-P-0319-0011 | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T18:07:54Z | 0 | 0 | 0900006480447e17 | |||
| FDA-2005-P-0319-0014 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Attachment 3 - "Labeling Information..." - [Luitpold Pharmaceuticals, Inc. - Supplement] re FDA-2005-P-0319-0011 | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T18:13:02Z | 0 | 0 | 0900006480447e19 | |||
| FDA-2005-P-0319-0013 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Attachment 2 - "Labeling Information..." - [Luitpold Pharmaceuticals, Inc. - Supplement] re FDA-2005-P-0319-0011 | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T18:12:41Z | 0 | 0 | 0900006480447e1b | |||
| FDA-2005-P-0319-0008 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Exhibit 11 - "Caveat Document" - [Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal, LLP) - Citizen Petition] re FDA-2005-P-0319-0004 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T17:52:24Z | 0 | 0 | 0900006480447e0d | |||
| FDA-2005-P-0319-0006 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Exhibit 4 - "FDA/CDER Approval Response to Luitpold Pharmaceuticals, Inc. - [Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal, LLP) - Citizen Petition] re FDA-2005-P-0319-0004 | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T17:51:21Z | 0 | 0 | 0900006480447dfb | |||
| FDA-2005-P-0319-0015 | FDA | Withhold Approval of any ANDA or any 505(b)(2) Application for any Generic Version or Other Pharmaceutical Alternative of Venofer(Iron Sucrose Injection, USP) FDA-2005-P-0319 | Sonnenschein Nath & Rosenthal LLP (Luitpold Pharmaceuticals, Inc., Withdrawal from Counsel, March 23, 2005) - Letter | Other | LET-Letter | 2010-05-14T04:00:00Z | 2010 | 5 | 2010-05-14T04:00:00Z | 2010-05-14T21:04:05Z | 0 | 0 | 0900006480447e10 |
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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);