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

5 rows where docket_id = "FDA-2015-P-3404" sorted by posted_date descending

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

posted_year 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2015-P-3404-0004 FDA None FDA-2015-P-3404 Determination That LIPTRUZET (Ezetimibe and Atorvastatin) Tablets, 10 Milligrams/10 Milligrams, 10 Milligrams/20 Milligrams, 10 Milligrams/40 Milligrams, and 10 Milligrams/80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2015-11-20T05:00:00Z 2015 11 2015-11-20T05:00:00Z   2015-12-01T20:22:32Z 2015-29639 0 0 0900006481d5e0b2
FDA-2015-P-3404-0005 FDA None FDA-2015-P-3404 Letter from FDA CDER to Lupin Pharmaceuticals, Inc. Other Letter(s) 2015-11-20T05:00:00Z 2015 11 2015-11-20T05:00:00Z   2015-11-20T22:03:18Z   0 0 0900006481d61232
FDA-2015-P-3404-0003 FDA None FDA-2015-P-3404 Acknowledgement Letter from FDA DDM to Lupin Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2015-09-25T04:00:00Z 2015 9 2015-09-25T04:00:00Z   2015-09-25T15:49:00Z   0 0 0900006481c8f3b4
FDA-2015-P-3404-0002 FDA None FDA-2015-P-3404 Attachment 1 Prescription and Over the Counter Drug Product List from the Orange Book re Citizen Petition from Lupin Pharmaceuticals, Inc. Supporting & Related Material Background Material 2015-09-25T04:00:00Z 2015 9     2015-09-25T15:48:46Z   0 0 0900006481c8f3b3
FDA-2015-P-3404-0001 FDA None FDA-2015-P-3404 Citizen Petition from Lupin Pharmaceuticals, Inc. Other Citizen Petition 2015-09-25T04:00:00Z 2015 9 2015-09-25T04:00:00Z   2024-11-11T21:04:04Z   1 0 0900006481c8f3b1

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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;