documents
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)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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;