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

8 rows where docket_id = "FDA-2016-E-4589" sorted by posted_date descending

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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, posted_date (date), comment_start_date (date), comment_end_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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-E-4589-0008 FDA None FDA-2016-E-4589 Letter to U. S. Patent and Trademark Office Other Letter(s) 2025-11-24T05:00:00Z 2025 11 2025-11-24T05:00:00Z   2025-11-25T03:04:10Z   0 0 09000064b909515b
FDA-2016-E-4589-0007 FDA None FDA-2016-E-4589 Letter to U. S. Patent and Trademark Office Other Letter(s) 2025-09-19T04:00:00Z 2025 9 2025-09-19T04:00:00Z   2025-09-19T20:44:37Z   0 0 09000064b8fb490e
FDA-2016-E-4589-0006 FDA None FDA-2016-E-4589 Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER Notice Determinations 2024-12-30T05:00:00Z 2024 12 2024-12-30T05:00:00Z 2025-03-01T04:59:59Z 2024-12-30T17:05:09Z 2024-31023 0 0 0900006486894e08
FDA-2016-E-4589-0005 FDA None FDA-2016-E-4589 Letter to U.S. Patent and Trademark Office Other Letter(s) 2024-12-19T05:00:00Z 2024 12 2024-12-19T05:00:00Z   2024-12-19T13:28:28Z   0 0 090000648687e04c
FDA-2016-E-4589-0004 FDA None FDA-2016-E-4589 Letter from U.S. Patent and Trademark Office to FDA CDER Other Letter(s) 2024-03-22T04:00:00Z 2024 3 2024-03-22T04:00:00Z   2024-03-22T18:17:26Z   0 0 090000648648d31c
FDA-2016-E-4589-0003 FDA None FDA-2016-E-4589 Letter to U S Patent and Trademark Office Other Letter(s) 2023-10-20T04:00:00Z 2023 10 2023-10-20T04:00:00Z   2025-11-01T00:49:18Z   0 0 09000064861135ef
FDA-2016-E-4589-0001 FDA None FDA-2016-E-4589 Patent Extension Application from Cooley LLP (on behalf of Collegium Pharmaceutical, Inc) Other Application 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z   2016-12-28T17:56:06Z   0 0 090000648243b75c
FDA-2016-E-4589-0002 FDA None FDA-2016-E-4589 Letter from U.S. Patent and Trademark Office to CDER Other Letter(s) 2016-12-28T05:00:00Z 2016 12 2016-12-28T05:00:00Z   2016-12-28T18:00:41Z   0 0 090000648243b3fe

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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;