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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

5 rows where docket_id = "FDA-2026-P-1306" 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 3

  • Other 3
  • Notice 1
  • Supporting & Related Material 1

posted_year 1

  • 2026 5

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2026-P-1306-0005 FDA Requests that the FDA to determine whether the Reference Listed Drug (RLD) DEXAMETHASONE ELIXIR, 0.5 mg/5 mL; Abbreviated New Drug Application (ANDA) 088254 of PHARMOBEDIENT CONSULTING has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-1306 Response Letter Other Letter(s) 2026-05-06T04:00:00Z 2026 5 2026-05-06T04:00:00Z   2026-05-06T20:50:07Z   0 0 09000064b92c5f8f
FDA-2026-P-1306-0004 FDA Requests that the FDA to determine whether the Reference Listed Drug (RLD) DEXAMETHASONE ELIXIR, 0.5 mg/5 mL; Abbreviated New Drug Application (ANDA) 088254 of PHARMOBEDIENT CONSULTING has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-1306 Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2026-05-06T04:00:00Z 2026 5 2026-05-06T04:00:00Z   2026-05-06T17:34:01Z 2026-08939 0 0 09000064b92c65a4
FDA-2026-P-1306-0001 FDA Requests that the FDA to determine whether the Reference Listed Drug (RLD) DEXAMETHASONE ELIXIR, 0.5 mg/5 mL; Abbreviated New Drug Application (ANDA) 088254 of PHARMOBEDIENT CONSULTING has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-1306 Citizen Petition from Lachman Consultant Services, Inc. Other Citizen Petition 2026-02-05T05:00:00Z 2026 2 2026-02-05T05:00:00Z   2026-05-06T18:25:24Z   0 0 09000064b9193898
FDA-2026-P-1306-0003 FDA Requests that the FDA to determine whether the Reference Listed Drug (RLD) DEXAMETHASONE ELIXIR, 0.5 mg/5 mL; Abbreviated New Drug Application (ANDA) 088254 of PHARMOBEDIENT CONSULTING has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-1306 Attachment 1 Supporting & Related Material Background Material 2026-02-05T05:00:00Z 2026 2     2026-02-06T00:30:22Z   0 0 09000064b91938a0
FDA-2026-P-1306-0002 FDA Requests that the FDA to determine whether the Reference Listed Drug (RLD) DEXAMETHASONE ELIXIR, 0.5 mg/5 mL; Abbreviated New Drug Application (ANDA) 088254 of PHARMOBEDIENT CONSULTING has been voluntarily withdrawn from sale for safety or efficacy reasons. FDA-2026-P-1306 Acknowledgement Letter from FDA DMB to Lachman Consultant Services, Inc. Other Acknowledgement Letter/Receipt 2026-02-05T05:00:00Z 2026 2 2026-02-05T05:00:00Z   2026-02-06T00:30:15Z   0 0 09000064b919389e

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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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