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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

2 rows where docket_id = "FDA-2003-P-0126" and posted_year = 2003 sorted by posted_date descending

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

posted_year 1

  • 2003 · 2 ✖

document_type 1

  • Other 2

agency_id 1

  • FDA 2
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-P-0126-0002 FDA Requesting the Agency to Permit the Fling of an ANDA for A Drug Product (1.5 mg Levonorgestrel Tablet) Which is Not Indentical to the Reference Listed Drug (Plan B 0.75 mg Levonorgestrel Tablet) In Strength-CLOSED FDA-2003-P-0126 Petition Denial from FDA CDER to HRA Pharma Other PDN-Petition Denial 2003-12-23T05:00:00Z 2003 12 2003-12-17T05:00:00Z   2024-10-17T21:12:42Z   0 0 09000064804861cf
FDA-2003-P-0126-0001 FDA Requesting the Agency to Permit the Fling of an ANDA for A Drug Product (1.5 mg Levonorgestrel Tablet) Which is Not Indentical to the Reference Listed Drug (Plan B 0.75 mg Levonorgestrel Tablet) In Strength-CLOSED FDA-2003-P-0126 Acknowledgment Letter from FDA DMB to HRA PHARMA Other Acknowledgement Letter/Receipt 2003-06-03T04:00:00Z 2003 6 2003-05-23T04:00:00Z   2024-10-17T20:57:53Z   0 0 090000648048617b

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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    withdrawn INTEGER,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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