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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

11 rows where docket_id = "FDA-2010-P-0630" sorted by posted_date descending

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

document_type 3

  • Supporting & Related Material 6
  • Other 4
  • Notice 1

posted_year 2

  • 2010 9
  • 2011 2

agency_id 1

  • FDA 11
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-P-0630-0011 FDA None FDA-2010-P-0630 FDA/CDER Response to Heyl Chemisch-Pharmazeutische Fabrik GmbH & Co. KG - Letter Other Letter(s) 2011-08-24T04:00:00Z 2011 8 2011-08-24T04:00:00Z   2012-05-09T22:40:57Z   0 0 0900006480eeb794
FDA-2010-P-0630-0010 FDA None FDA-2010-P-0630 Determination That PENTETATE ZINC TRISODIUM (Zinc Trisodium Diethylenetriaminepentaacetate) Solution for Intravenous or Inhalation Administration, Equivalent to 1 Gram Base/5 Milliliters (Equivalent to 200 Milligrams Base/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice General Notice 2011-08-19T04:00:00Z 2011 8     2012-05-09T22:35:44Z 2011-21245 0 0 0900006480ee5641
FDA-2010-P-0630-0009 FDA None FDA-2010-P-0630 Acknowledgement Letter to Heyltex Corporation, HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG - Correction Other Correction(s) 2010-12-27T05:00:00Z 2010 12 2010-12-27T05:00:00Z   2012-05-09T22:38:35Z   0 0 0900006480bbd326
FDA-2010-P-0630-0008 FDA None FDA-2010-P-0630 Attachment XII - "Jekat, F. et al. IPCS Evaluation of Antidotes for Poisoning by Metals and Metalloids - Heyltex Corporation - [HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-12-27T05:00:00Z 2010 12     2010-12-27T19:31:41Z   0 0 0900006480bb3e08
FDA-2010-P-0630-0006 FDA None FDA-2010-P-0630 Attachment VI - "Development of biokinetic models for the description of the effect of DTPA with regard to the diagnostic and therapy of incorporation of plutonium and other transuranium elements" - Heyltex Corporation - [HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-12-27T05:00:00Z 2010 12     2010-12-27T19:29:18Z   0 0 0900006480bb3df7
FDA-2010-P-0630-0007 FDA None FDA-2010-P-0630 Attachment VIII - Mayak Worker Study Project 2.4 Volume III Internal Dosimetry Dose Reconstruction Methods Used in Preparation of Dose-2005 Database - Heyltex Corporation - [HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-12-27T05:00:00Z 2010 12     2010-12-27T19:30:48Z   0 0 0900006480bb3df9
FDA-2010-P-0630-0003 FDA None FDA-2010-P-0630 Attachment I - From: "Young, Johnny"<Johnny.Young@fda.hhs.gov> "Suitability Petition 2009-P-0258 (Pentetate Zinc Trisodium Injection" - Heyltex Corporation - [HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-12-20T05:00:00Z 2010 12     2010-12-20T19:29:05Z   0 0 0900006480bb3df2
FDA-2010-P-0630-0002 FDA None FDA-2010-P-0630 Acknowledgement Letter to Heyltex Corporation, HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG Other Acknowledgement Letter/Receipt 2010-12-20T05:00:00Z 2010 12 2010-12-20T05:00:00Z   2012-05-09T22:31:38Z   0 0 0900006480bb3e0a
FDA-2010-P-0630-0001 FDA None FDA-2010-P-0630 Heyltex Corporation, HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG - Citizen Petition Other Citizen Petition 2010-12-20T05:00:00Z 2010 12 2010-12-20T05:00:00Z   2024-11-07T22:26:27Z   1 0 0900006480bb3df1
FDA-2010-P-0630-0005 FDA None FDA-2010-P-0630 Attachment III - Federal Register/Vol. 68, No. 178/Monday, September 15, 2003/Notices 53989 - Heyltex Corporation - [HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-12-20T05:00:00Z 2010 12     2010-12-20T19:34:58Z   0 0 0900006480bb3df4
FDA-2010-P-0630-0004 FDA None FDA-2010-P-0630 Attachment II - Orange Book Detail Record Search - Heyltex Corporation - [HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2010-12-20T05:00:00Z 2010 12     2010-12-20T19:30:33Z   0 0 0900006480bb3df3

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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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