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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

21 rows where agency_id = "FDA" and docket_id = "FDA-2005-P-0319" sorted by posted_date descending

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posted_year 5

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  • 2005 3
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  • FDA · 21 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0319-0022 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 Final Response Other Response(s) 2025-08-08T04:00:00Z 2025 8 2025-08-08T04:00:00Z   2025-08-08T19:50:15Z   0 0 09000064b8ef32d7
FDA-2005-P-0319-0021 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 Mulin Richter & Hampton LLP) - Amendment Other Amendment 2012-10-01T04:00:00Z 2012 10 2012-10-01T04:00:00Z   2012-10-02T01:38:06Z   0 0 09000064810a6755
FDA-2005-P-0319-0019 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 2011-03-18T04:00:00Z 2011 3 2011-03-18T04:00:00Z   2013-08-11T03:13:29Z   0 0 0900006480c014b3
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
FDA-2005-P-0319-0003 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 FDA/CDER Interim Response to Luitpold Pharmaceuticals Inc Other LET-Letter 2005-09-07T04:00:00Z 2005 9     2010-05-14T21:07:52Z   0 0 0900006480447e12
FDA-2005-P-0319-0001 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 See FDA-2005-P-0319-0002 Supporting & Related Material BKG-Background Material 2005-03-07T05:00:00Z 2005 3     2010-05-14T21:10:44Z   0 0 0900006480447df8
FDA-2005-P-0319-0002 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 Acknowledgement Letter to Luitpold Pharmaceuticals, Inc., (Sonnenschein Nath & Rosenthal LLP) Other ACK-Acknowledgement Letter 2005-03-07T05:00:00Z 2005 3     2010-05-14T21:06:03Z   0 0 0900006480447e0e

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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);
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