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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

10 rows where agency_id = "FDA" and docket_id = "FDA-2007-N-0035" 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 3

  • 2008 5
  • 2010 3
  • 2007 2

document_type 1

  • Other 10

agency_id 1

  • FDA · 10 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2007-N-0035-0028 FDA None FDA-2007-N-0035 See FDA-2007-N-0035-0027 for Petition for Stay Contents Other PSA-Petition for Stay 2010-01-05T05:00:00Z 2010 1 2010-01-05T05:00:00Z   2010-01-05T13:38:42Z   0 0 0900006480a76720
FDA-2007-N-0035-0027 FDA None FDA-2007-N-0035 Petition for Stay of Action from Aapotex, Inc. Other Petition(s) 2010-01-05T05:00:00Z 2010 1     2025-08-13T19:42:47Z   0 0 09000064804295b2
FDA-2007-N-0035-0029 FDA None FDA-2007-N-0035 FDA/CDER/OGD to Apotex, Inc. - Petition Denial Other PDN-Petition Denial 2010-01-05T05:00:00Z 2010 1 2010-01-05T05:00:00Z   2013-07-27T23:03:36Z   0 0 0900006480a76722
FDA-2007-N-0035-0014 FDA None FDA-2007-N-0035 Acknowledgement Letter from FDA DDM to Apotex, Inc. Other Acknowledgement Letter/Receipt 2008-05-15T04:00:00Z 2008 5 2008-05-15T04:00:00Z   2025-08-13T19:26:00Z   0 0 09000064804295b4
FDA-2007-N-0035-0017 FDA None FDA-2007-N-0035 Letter from Foley & Lardner LLP to FDA DMB to FDA CDER, on behalf of Cobalt Pharmaceuticals, Inc Other Letter(s) 2008-05-15T04:00:00Z 2008 5     2025-08-13T19:37:21Z   0 0 09000064804295bb
FDA-2007-N-0035-0003 FDA None FDA-2007-N-0035 Letter from Hyman, Phelps & McNamara, P.C. to FDA CDER Other Letter(s) 2008-05-13T04:00:00Z 2008 5 2008-05-13T04:00:00Z   2025-08-13T18:59:08Z   0 0 090000648053a4b6
FDA-2007-N-0035-0005 FDA None FDA-2007-N-0035 Letter from Buc & Beardsley, on behalf of Lupin Pharmaceuticals, Inc Other Letter(s) 2008-05-13T04:00:00Z 2008 5     2025-08-13T19:18:54Z   0 0 0900006480429599
FDA-2007-N-0035-0004 FDA None FDA-2007-N-0035 Letter to FDA CDER to Buc & Beardsley Other Letter(s) 2008-05-13T04:00:00Z 2008 5     2025-08-13T19:07:47Z   0 0 090000648053a597
FDA-2007-N-0035-0002 FDA None FDA-2007-N-0035 Number not used Other ACK-Acknowledgement Letter 2007-11-15T05:00:00Z 2007 11     2008-04-04T00:35:32Z   0 0 09000064804295b6
FDA-2007-N-0035-0001 FDA None FDA-2007-N-0035 Letter from FDA CDER to ANDA Applicant Other Letter(s) 2007-10-03T04:00:00Z 2007 10     2025-08-13T18:40:54Z   0 0 0900006480429591

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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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