documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
6 rows where docket_id = "FDA-2025-E-0161" sorted by posted_date descending
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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2025-E-0161-0006 | FDA | None FDA-2025-E-0161 | Determination of Regulatory Review Period for Purposes of Patent Extension; ORLYNVAH | Notice | Determinations | 2026-02-26T05:00:00Z | 2026 | 2 | 2026-02-26T05:00:00Z | 2026-04-28T03:59:59Z | 2026-02-26T20:55:38Z | 2026-03848 | 1 | 0 | 09000064b91deb09 |
| FDA-2025-E-0161-0005 | FDA | None FDA-2025-E-0161 | Letter from FDA CDER to U.S. Patent and Trademark Office | Other | Letter(s) | 2025-12-02T05:00:00Z | 2025 | 12 | 2025-12-02T05:00:00Z | 2025-12-03T02:27:37Z | 0 | 0 | 09000064b90aa311 | ||
| FDA-2025-E-0161-0004 | FDA | None FDA-2025-E-0161 | Letter from U.S. Patent and Trademark Office to FDA CDER | Other | Letter(s) | 2025-11-05T05:00:00Z | 2025 | 11 | 2025-11-05T05:00:00Z | 2025-11-05T22:27:33Z | 0 | 0 | 09000064b9069679 | ||
| FDA-2025-E-0161-0003 | FDA | None FDA-2025-E-0161 | Letter from FDA CDER to U.S. Patent and Trademark Office | Other | Letter(s) | 2025-09-26T04:00:00Z | 2025 | 9 | 2025-09-26T04:00:00Z | 2025-11-05T18:01:02Z | 0 | 0 | 09000064b8fdf76c | ||
| FDA-2025-E-0161-0002 | FDA | None FDA-2025-E-0161 | Patent Extension Application from Cooley LLP (on behalf of Pfizer, Inc) | Other | Application | 2025-01-15T05:00:00Z | 2025 | 1 | 2025-01-15T05:00:00Z | 2025-01-15T21:15:24Z | 0 | 0 | 09000064868bcb1c | ||
| FDA-2025-E-0161-0001 | FDA | None FDA-2025-E-0161 | Letter from U.S. Patent and Trademark Office to FDA CDER | Other | Letter(s) | 2025-01-15T05:00:00Z | 2025 | 1 | 2025-01-15T05:00:00Z | 2025-01-15T21:15:18Z | 0 | 0 | 09000064868bcb1a |
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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;