documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
16 rows where docket_id = "FDA-2022-N-2390" and posted_year = 2025 sorted by posted_date descending
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Suggested facets: title, subtype, posted_date, posted_month, comment_start_date, 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2022-N-2390-0585 | FDA | None FDA-2022-N-2390 | Revised Letter re: CDER and Vanda’s Joint Request | Other | Letter(s) | 2025-10-21T04:00:00Z | 2025 | 10 | 2025-10-21T04:00:00Z | 2025-10-21T17:13:39Z | 0 | 0 | 09000064b903ed93 | ||
| FDA-2022-N-2390-0584 | FDA | None FDA-2022-N-2390 | Letter from FDA OC to Vanda Pharmaceuticals Inc. and FDA CDER | Other | Letter(s) | 2025-10-15T04:00:00Z | 2025 | 10 | 2025-10-15T04:00:00Z | 2025-10-15T15:52:08Z | 0 | 0 | 09000064b9015606 | ||
| FDA-2022-N-2390-0581 | FDA | None FDA-2022-N-2390 | Vanda Pharmaceuticals Inc.'s Submission in Support of Summary Judgment to the Applicant or a Hearing on Approvability | Other | Brief | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-10-15T15:05:12Z | 0 | 0 | 09000064869b6834 | ||
| FDA-2022-N-2390-0161 | FDA | None FDA-2022-N-2390 | Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon) | Notice | Notice of Denial | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-03-07T14:52:35Z | 2025-03697 | 0 | 0 | 09000064869b9231 | |
| FDA-2022-N-2390-0580 | FDA | None FDA-2022-N-2390 | Cover Letter from Vanda Pharmaceuticals Inc. | Other | Letter(s) | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-10-15T15:04:57Z | 0 | 0 | 09000064869b682f | ||
| FDA-2022-N-2390-0582 | FDA | None FDA-2022-N-2390 | Declaration of Thomas Roth | Other | Declaration(s) | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-10-15T15:05:31Z | 0 | 0 | 09000064869b6836 | ||
| FDA-2022-N-2390-0583 | FDA | None FDA-2022-N-2390 | Declaration of Daniel Combs | Other | Declaration(s) | 2025-03-07T05:00:00Z | 2025 | 3 | 2025-03-07T05:00:00Z | 2025-10-15T15:05:43Z | 0 | 0 | 09000064869b6838 | ||
| FDA-2022-N-2390-0132 | FDA | None FDA-2022-N-2390 | Vanda Pharmaceuticals Inc.’s Submission in Support of Summary Judgment to the Applicant or a Hearing on Approvability of Tasimelteon to Treat Insomnia Associated with Difficulties with Sleep Initiation | Other | Brief | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:31:50Z | 0 | 0 | 0900006486972393 | ||
| FDA-2022-N-2390-0133 | FDA | None FDA-2022-N-2390 | First Declaration of Thomas Roth | Other | Declaration(s) | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:31:56Z | 0 | 0 | 09000064869723be | ||
| FDA-2022-N-2390-0135 | FDA | None FDA-2022-N-2390 | Agency Decision Hetlioz for Insomnia | Other | Agency Response | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:32:32Z | 0 | 0 | 0900006486995bdc | ||
| FDA-2022-N-2390-0134 | FDA | None FDA-2022-N-2390 | Second Declaration of Thomas Roth | Other | Declaration(s) | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:32:01Z | 0 | 0 | 09000064869723c0 | ||
| FDA-2022-N-2390-0131 | FDA | None FDA-2022-N-2390 | Cover Letter from Vanda Pharmaceuticals Inc. | Other | Letter(s) | 2025-03-04T05:00:00Z | 2025 | 3 | 2025-03-04T05:00:00Z | 2025-03-04T14:31:42Z | 0 | 0 | 090000648697238f | ||
| FDA-2022-N-2390-0130 | FDA | None FDA-2022-N-2390 | CDER Proposed Order_ Docket No. FDA-2022-N-2390 (Vanda Pharmaceuticals Inc. Hearing Request for sNDA 205677-012) | Other | Electronic Letter | 2025-01-29T05:00:00Z | 2025 | 1 | 2025-01-29T05:00:00Z | 2025-01-29T21:43:58Z | 0 | 0 | 0900006486908a5f | ||
| FDA-2022-N-2390-0071 | FDA | None FDA-2022-N-2390 | Response Cover Letter from Vanda Pharmaceuticals Inc. to FDA DMB | Other | Letter(s) | 2025-01-07T05:00:00Z | 2025 | 1 | 2025-01-07T05:00:00Z | 2025-01-07T15:56:31Z | 0 | 0 | 09000064868a3b18 | ||
| FDA-2022-N-2390-0073 | FDA | None FDA-2022-N-2390 | Third Declaration of Thomas Roth | Other | Declaration(s) | 2025-01-07T05:00:00Z | 2025 | 1 | 2025-01-07T05:00:00Z | 2025-01-07T15:56:43Z | 0 | 0 | 09000064868a45ad | ||
| FDA-2022-N-2390-0072 | FDA | None FDA-2022-N-2390 | Insomnia Response Submission Brief | Other | Brief | 2025-01-07T05:00:00Z | 2025 | 1 | 2025-01-07T05:00:00Z | 2025-01-07T15:56:37Z | 0 | 0 | 09000064868a4591 |
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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;