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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

4 rows where docket_id = "FDA-2026-P-0655" sorted by posted_date descending

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

document_type 2

  • Other 3
  • Notice 1

posted_year 1

  • 2026 4

agency_id 1

  • FDA 4
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2026-P-0655-0003 FDA Request that the FDA determine that the listed RLD product FENOGLIDE (fenofibrate) Tablets, 40 mg and 120 mg, N022118, NDA Holder– Salix Pharmaceuticals INC, was not discontinued for safety or effectiveness reasons FDA-2026-P-0655 Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2026-04-30T04:00:00Z 2026 4     2026-04-30T17:56:39Z 2026-08390 0 0 09000064b92b7f6c
FDA-2026-P-0655-0004 FDA Request that the FDA determine that the listed RLD product FENOGLIDE (fenofibrate) Tablets, 40 mg and 120 mg, N022118, NDA Holder– Salix Pharmaceuticals INC, was not discontinued for safety or effectiveness reasons FDA-2026-P-0655 Final Response Other Letter(s) 2026-04-30T04:00:00Z 2026 4 2026-04-30T04:00:00Z   2026-04-30T20:27:00Z   0 0 09000064b92b88a0
FDA-2026-P-0655-0002 FDA Request that the FDA determine that the listed RLD product FENOGLIDE (fenofibrate) Tablets, 40 mg and 120 mg, N022118, NDA Holder– Salix Pharmaceuticals INC, was not discontinued for safety or effectiveness reasons FDA-2026-P-0655 Acknowledgment Letter from FDA DMB to Foley & Lardner, LLP Other Acknowledgement Letter/Receipt 2026-01-21T05:00:00Z 2026 1 2026-01-21T05:00:00Z   2026-01-22T02:12:53Z   0 0 09000064b91758a2
FDA-2026-P-0655-0001 FDA Request that the FDA determine that the listed RLD product FENOGLIDE (fenofibrate) Tablets, 40 mg and 120 mg, N022118, NDA Holder– Salix Pharmaceuticals INC, was not discontinued for safety or effectiveness reasons FDA-2026-P-0655 Citizen Petition from Foley & Lardner, LLP Other Citizen Petition 2026-01-21T05:00:00Z 2026 1 2026-01-21T05:00:00Z   2026-04-30T18:44:16Z   0 0 09000064b917589f

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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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