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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

comment_end_date
A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
comment_start_date
A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)

5 rows where docket_id = "FDA-2022-P-0558" sorted by posted_date descending

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posted_year 3

  • 2022 2
  • 2023 2
  • 2026 1

document_type 2

  • Other 3
  • Notice 2

agency_id 1

  • FDA 5
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2022-P-0558-0005 FDA Requests that the FDA to determine if the Reference Listed Drug (RLD), OXANDRIN (oxandrolone tablets, USP) 2.5 mg and 10 mg, NDA 013718 owned by Gemini Laboratories LLC was voluntarily withdrawn from sale for reasons of safety or effectiveness to facilitate the approval of generic version. FDA-2022-P-0558 Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction Notice Correction 2026-10-07T04:00:00Z 2026 10 2026-10-07T04:00:00Z   2026-10-07T18:02:12Z 2026-20503 0 0 09000064b96482e9
FDA-2022-P-0558-0003 FDA Requests that the FDA to determine if the Reference Listed Drug (RLD), OXANDRIN (oxandrolone tablets, USP) 2.5 mg and 10 mg, NDA 013718 owned by Gemini Laboratories LLC was voluntarily withdrawn from sale for reasons of safety or effectiveness to facilitate the approval of generic version. FDA-2022-P-0558 Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2023-09-13T04:00:00Z 2023 9     2023-09-13T15:14:45Z 2023-19796 0 0 0900006485f949ad
FDA-2022-P-0558-0004 FDA Requests that the FDA to determine if the Reference Listed Drug (RLD), OXANDRIN (oxandrolone tablets, USP) 2.5 mg and 10 mg, NDA 013718 owned by Gemini Laboratories LLC was voluntarily withdrawn from sale for reasons of safety or effectiveness to facilitate the approval of generic version. FDA-2022-P-0558 Citizen Petition Approval from FDA CDER to Novitium Pharma LLC Other Approval 2023-09-13T04:00:00Z 2023 9 2023-09-13T04:00:00Z   2023-09-13T16:45:09Z   0 0 0900006485f97548
FDA-2022-P-0558-0001 FDA Requests that the FDA to determine if the Reference Listed Drug (RLD), OXANDRIN (oxandrolone tablets, USP) 2.5 mg and 10 mg, NDA 013718 owned by Gemini Laboratories LLC was voluntarily withdrawn from sale for reasons of safety or effectiveness to facilitate the approval of generic version. FDA-2022-P-0558 Citizen Petition from Novitium Pharma LLC Other Citizen Petition 2022-04-08T04:00:00Z 2022 4 2022-04-08T04:00:00Z   2023-09-13T15:59:42Z   0 0 0900006485000295
FDA-2022-P-0558-0002 FDA Requests that the FDA to determine if the Reference Listed Drug (RLD), OXANDRIN (oxandrolone tablets, USP) 2.5 mg and 10 mg, NDA 013718 owned by Gemini Laboratories LLC was voluntarily withdrawn from sale for reasons of safety or effectiveness to facilitate the approval of generic version. FDA-2022-P-0558 Acknowledgment Letter from FDA DMS to Novitium Pharma LLC Other Acknowledgement Letter/Receipt 2022-04-08T04:00:00Z 2022 4 2022-04-08T04:00:00Z   2022-04-08T13:33:43Z   0 0 09000064850002fe

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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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