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

15 rows where docket_id = "FDA-2006-P-0346" sorted by posted_date descending

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

posted_year 4

document_type 2

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0346-0017 FDA None FDA-2006-P-0346 FDA/CDER to Endo Pharmaceuticals - Partial Petition Approval and Denial Other Partial Petition Approval and Denial 2012-08-23T04:00:00Z 2012 8 2012-08-23T04:00:00Z   2012-08-23T19:44:14Z   0 0 09000064810ee52b
FDA-2006-P-0346-0016 FDA None FDA-2006-P-0346 Endo Pharmaceuticals - Amendment Other Amendment 2012-05-30T04:00:00Z 2012 5 2012-05-30T04:00:00Z   2012-05-30T15:16:38Z   0 0 0900006480fd877e
FDA-2006-P-0346-0013 FDA None FDA-2006-P-0346 Endo Pharmaceuticals, Inc. - Comment - Tab C - Background on OGD's Approval of Generic Copies of EMLA Cream Based on Pharmacokinetics Supporting & Related Material AMD-(Supporting and Related Material) 2008-11-17T05:00:00Z 2008 11     2008-11-17T18:38:59Z   0 0 090000648045f28b
FDA-2006-P-0346-0012 FDA None FDA-2006-P-0346 Endo Pharmaceuticals, Inc. - Comment - Exhibit 1 - Letter from Dale Conner, Director of Bioequivalence, OGD (Oct. 5, 2006) Supporting & Related Material AMD-(Supporting and Related Material) 2008-11-17T05:00:00Z 2008 11     2008-11-17T18:38:58Z   0 0 090000648045f288
FDA-2006-P-0346-0015 FDA None FDA-2006-P-0346 Endo Pharmaceuticals, Inc. - Comment - Tab A - Oral Versus Topical Dosage Form Performance Supporting & Related Material AMD-(Supporting and Related Material) 2008-11-17T05:00:00Z 2008 11     2008-11-17T18:39:02Z   0 0 090000648045f28e
FDA-2006-P-0346-0011 FDA None FDA-2006-P-0346 Endo Pharmaceuticals, Inc. - Comment - Exhibit 16 - 98D-0388, C 12 Supporting & Related Material AMD-(Supporting and Related Material) 2008-11-17T05:00:00Z 2008 11     2008-11-17T18:38:57Z   0 0 090000648045f26f
FDA-2006-P-0346-0006 FDA None FDA-2006-P-0346 Endo Pharmaceuticals Inc - Citizen Petition Other Citizen Petition 2008-11-17T05:00:00Z 2008 11 2008-11-17T05:00:00Z   2012-08-23T19:41:05Z   0 0 090000648045f24f
FDA-2006-P-0346-0007 FDA None FDA-2006-P-0346 Endo Pharmaceuticals Inc - Tab A - October 5, 2006 Letter, Reference OGD #06-0100 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2008-11-17T05:00:00Z 2008 11     2008-11-17T17:09:30Z   0 0 090000648045f252
FDA-2006-P-0346-0014 FDA None FDA-2006-P-0346 Endo Pharmaceuticals, Inc. - Comment - Tab B - Evaluation and Withdrawal of Draft Guidance for Topical Product Bioequivalence Supporting & Related Material AMD-(Supporting and Related Material) 2008-11-17T05:00:00Z 2008 11     2008-11-17T18:39:00Z   0 0 090000648045f28d
FDA-2006-P-0346-0008 FDA None FDA-2006-P-0346 Endo Pharmaceuticals Inc., Correction Letter to FDA - Letter Other CR-Correction 2008-11-17T05:00:00Z 2008 11 2008-11-17T05:00:00Z   2012-04-18T22:44:54Z   0 0 090000648045f264
FDA-2006-P-0346-0005 FDA None FDA-2006-P-0346 FDA/CDER Interim Response to Endo Pharmaceuticals - Letter Other Letter(s) 2007-06-25T04:00:00Z 2007 6     2012-04-18T23:20:36Z   0 0 090000648045f26e
FDA-2006-P-0346-0004 FDA None FDA-2006-P-0346 Corrected Acknowledgement Letter to Endo Pharmaceuticals Inc Other Correction(s) 2006-12-21T05:00:00Z 2006 12     2012-04-18T22:53:07Z   0 0 090000648045f269
FDA-2006-P-0346-0003 FDA None FDA-2006-P-0346 See FDA-2006-P-0346-0004 Supporting & Related Material Correction 2006-12-21T05:00:00Z 2006 12     2012-04-18T23:13:08Z   0 0 090000648045f268
FDA-2006-P-0346-0002 FDA None FDA-2006-P-0346 See FDA-2006-P-0346-0001 Supporting & Related Material Acknowledgement Letter/Receipt 2006-12-18T05:00:00Z 2006 12     2012-04-18T23:14:41Z   0 0 090000648045f263
FDA-2006-P-0346-0001 FDA None FDA-2006-P-0346 Acknowledgement Letter to Endo Pharmaceuticals Inc Other Acknowledgement Letter/Receipt 2006-12-18T05:00:00Z 2006 12     2012-04-18T22:43:25Z   0 0 090000648045f22c

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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;