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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-2026-P-1300" sorted by posted_date descending

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Suggested facets: subtype, posted_date, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), last_modified (date)

document_type 2

  • Supporting & Related Material 4
  • Other 3

posted_year 1

  • 2026 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2026-P-1300-0006 FDA None FDA-2026-P-1300 Attachment 1 - RLD BELSOMRA® (Suvorexant) Tablets 5 mg, 10 mg, 15 mg and 20 mg Package Insert Supporting & Related Material Background Material 2026-02-27T05:00:00Z 2026 2     2026-02-27T23:32:57Z   0 0 09000064b91e3e19
FDA-2026-P-1300-0007 FDA None FDA-2026-P-1300 Attachment 2 - RLD BELSOMRA® (Suvorexant) Tablets 5 mg, 10 mg, 15 mg and 20 mg Approval Letter Supporting & Related Material Background Material 2026-02-27T05:00:00Z 2026 2     2026-02-27T23:33:00Z   0 0 09000064b91e3e1a
FDA-2026-P-1300-0005 FDA None FDA-2026-P-1300 Suitability Petition Amendment from APDM Pharmaceuticals Private Limited Other Amendment 2026-02-27T05:00:00Z 2026 2 2026-02-27T05:00:00Z   2026-02-27T23:32:34Z   1 0 09000064b91e3c62
FDA-2026-P-1300-0001 FDA None FDA-2026-P-1300 Suitability Petition from APDM Pharmaceuticals Private Limited Other Petition(s) 2026-02-05T05:00:00Z 2026 2 2026-02-05T05:00:00Z   2026-02-27T23:24:30Z   0 0 09000064b919045a
FDA-2026-P-1300-0002 FDA None FDA-2026-P-1300 Acknowledgment Letter from FDA DMB to APDM Pharmaceuticals Private Limited Other Acknowledgement Letter/Receipt 2026-02-05T05:00:00Z 2026 2 2026-02-05T05:00:00Z   2026-02-05T21:56:26Z   0 0 09000064b919045c
FDA-2026-P-1300-0003 FDA None FDA-2026-P-1300 Attachment 1 - Approved Drug Products with Therapeutic Equivalence Evaluations, Electronic Orange Book listing, accessed December 26, 2025 Supporting & Related Material Background Material 2026-02-05T05:00:00Z 2026 2     2026-02-05T21:58:06Z   0 0 09000064b91936e3
FDA-2026-P-1300-0004 FDA None FDA-2026-P-1300 Attachment 2 - Draft Insert Labeling for Proposed Product Supporting & Related Material Background Material 2026-02-05T05:00:00Z 2026 2     2026-02-05T21:58:09Z   0 0 09000064b91936e4

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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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