documents

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

13 rows where docket_id = "FDA-2010-P-0632" sorted by posted_date descending

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document_type 2

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2010-P-0632-0017 FDA None FDA-2010-P-0632 FDA/CDER to Sandoz, Inc. - Petition Denial Other Denial 2011-10-05T04:00:00Z 2011 10 2011-10-05T04:00:00Z   2012-05-09T22:14:38Z   0 0 0900006480f4cabe
FDA-2010-P-0632-0014 FDA None FDA-2010-P-0632 FDA/CDER Interim Response to Sandoz Inc. - Letter Other Letter(s) 2011-06-13T04:00:00Z 2011 6 2011-06-13T04:00:00Z   2011-06-13T21:20:29Z   0 0 0900006480e4ebcc
FDA-2010-P-0632-0004 FDA None FDA-2010-P-0632 Exhibit B - "2007 and October 2007 Orange Book Excerpts" - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:38Z   0 0 0900006480bb50da
FDA-2010-P-0632-0008 FDA None FDA-2010-P-0632 Exhibit F - "FDA July 26, 2010 Letter Regarding Doxercalciferol Injection" - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:45Z   0 0 0900006480bb5121
FDA-2010-P-0632-0009 FDA None FDA-2010-P-0632 Exhibit G - "FDA March 31, 2010 Letter Regarding Netaxalone Tablets" - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:46Z   0 0 0900006480bb5122
FDA-2010-P-0632-0012 FDA None FDA-2010-P-0632 Exhibit J - "FDA October 28, 2010 Letter Regarding Dorzolamide Hydrochloride and Timolol Maleate" - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:51Z   0 0 0900006480bb5125
FDA-2010-P-0632-0003 FDA None FDA-2010-P-0632 Exhibit A - "FDA October 19, 2010 Letter Regarding Doxercalciferol Injection" - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:37Z   0 0 0900006480bb50d7
FDA-2010-P-0632-0007 FDA None FDA-2010-P-0632 Exhibit E - "Statutory Disclaimer of all Claims in the '083 Patent " - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:43Z   0 0 0900006480bb5120
FDA-2010-P-0632-0011 FDA None FDA-2010-P-0632 Exhibit I - "FDA May 7, 2008 Letter Regarding Acarbose Tablets" - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:49Z   0 0 0900006480bb5124
FDA-2010-P-0632-0006 FDA None FDA-2010-P-0632 Exhibit D - "July 2009 Orange Book Excerpt" - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:41Z   0 0 0900006480bb511f
FDA-2010-P-0632-0010 FDA None FDA-2010-P-0632 Exhibit H - "FDA February 25, 2010 Approval Letter for Imiquimid Cream" - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:48Z   0 0 0900006480bb5123
FDA-2010-P-0632-0005 FDA None FDA-2010-P-0632 Exhibit C - "Paragraph IV Certifications" Website Excerpt" - [Sandoz, Inc. - Citizen Petition] Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2011-02-15T05:00:00Z 2011 2     2011-02-16T00:15:40Z   0 0 0900006480bb50dc
FDA-2010-P-0632-0001 FDA None FDA-2010-P-0632 Acknowledgement Letter to Sandoz, Inc. Other ACK-Acknowledgement Letter 2010-12-20T05:00:00Z 2010 12 2010-12-20T05:00:00Z   2011-06-13T21:16:33Z   0 0 0900006480bb5126

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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;