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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

7 rows where docket_id = "FDA-2025-P-2077" 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)

document_type 2

  • Other 4
  • Supporting & Related Material 3

posted_year 1

  • 2025 7

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-P-2077-0007 FDA None FDA-2025-P-2077 Response Letter Other Letter(s) 2025-12-31T05:00:00Z 2025 12 2025-12-31T05:00:00Z   2025-12-31T19:22:07Z   0 0 09000064b9111c53
FDA-2025-P-2077-0006 FDA None FDA-2025-P-2077 Completeness Assessment Correspondence Other Assessment Document or Analysis 2025-07-16T04:00:00Z 2025 7 2025-07-16T04:00:00Z   2025-07-16T18:34:06Z   0 0 09000064b8e77d29
FDA-2025-P-2077-0002 FDA None FDA-2025-P-2077 Acknowledgment Letter from FDA DMB to Premier Research Other Acknowledgement Letter/Receipt 2025-07-01T04:00:00Z 2025 7 2025-07-01T04:00:00Z   2025-07-01T19:56:25Z   0 0 09000064b8e4b993
FDA-2025-P-2077-0001 FDA None FDA-2025-P-2077 Suitability Petition from Premier Research Other Petition(s) 2025-07-01T04:00:00Z 2025 7 2025-07-01T04:00:00Z   2026-02-27T01:30:38Z   0 0 09000064b8e4b990
FDA-2025-P-2077-0003 FDA None FDA-2025-P-2077 Appendix 1 - Approved Product Labeling - Prozac Supporting & Related Material Background Material 2025-07-01T04:00:00Z 2025 7     2025-07-01T19:56:35Z   0 0 09000064b8e4bd79
FDA-2025-P-2077-0004 FDA None FDA-2025-P-2077 Appendix 2 - FDA Orange Book - Prozac Supporting & Related Material Background Material 2025-07-01T04:00:00Z 2025 7     2025-07-01T19:56:45Z   0 0 09000064b8e4bd7a
FDA-2025-P-2077-0005 FDA None FDA-2025-P-2077 Appendix 3 - Proposed Draft Labeling for the Fluoxetine Hydrochloride Capsules Supporting & Related Material Background Material 2025-07-01T04:00:00Z 2025 7     2025-07-01T19:56:53Z   0 0 09000064b8e4bd7b

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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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