documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
6 rows where docket_id = "FDA-2026-P-5978" sorted by posted_date descending
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Suggested facets: subtype, 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-5978-0004 | FDA | Requests that the FDA declare that Cyproheptadine HCL Tablets, 3 mg and 6 mg, are suitable for submission as an ANDA FDA-2026-P-5978 | Attachment 2 | Supporting & Related Material | Background Material | 2026-05-27T04:00:00Z | 2026 | 5 | 2026-05-27T22:44:44Z | 0 | 0 | 09000064b92f48ff | |||
| FDA-2026-P-5978-0006 | FDA | Requests that the FDA declare that Cyproheptadine HCL Tablets, 3 mg and 6 mg, are suitable for submission as an ANDA FDA-2026-P-5978 | Attachment 4 | Supporting & Related Material | Background Material | 2026-05-27T04:00:00Z | 2026 | 5 | 2026-05-27T22:44:48Z | 0 | 0 | 09000064b92f5d9b | |||
| FDA-2026-P-5978-0001 | FDA | Requests that the FDA declare that Cyproheptadine HCL Tablets, 3 mg and 6 mg, are suitable for submission as an ANDA FDA-2026-P-5978 | Suitability Petition from Hyman, Phelps & McNamara, P.C. | Other | Petition(s) | 2026-05-27T04:00:00Z | 2026 | 5 | 2026-05-27T04:00:00Z | 2026-05-27T22:42:13Z | 1 | 0 | 09000064b92f463a | ||
| FDA-2026-P-5978-0003 | FDA | Requests that the FDA declare that Cyproheptadine HCL Tablets, 3 mg and 6 mg, are suitable for submission as an ANDA FDA-2026-P-5978 | Attachment 1 | Supporting & Related Material | Background Material | 2026-05-27T04:00:00Z | 2026 | 5 | 2026-05-27T22:44:41Z | 0 | 0 | 09000064b92f48fe | |||
| FDA-2026-P-5978-0005 | FDA | Requests that the FDA declare that Cyproheptadine HCL Tablets, 3 mg and 6 mg, are suitable for submission as an ANDA FDA-2026-P-5978 | Attachment 3 | Supporting & Related Material | Background Material | 2026-05-27T04:00:00Z | 2026 | 5 | 2026-05-27T22:44:46Z | 0 | 0 | 09000064b92f5d00 | |||
| FDA-2026-P-5978-0002 | FDA | Requests that the FDA declare that Cyproheptadine HCL Tablets, 3 mg and 6 mg, are suitable for submission as an ANDA FDA-2026-P-5978 | Acknowledgement Letter from FDA DMB to Hyman, Phelps & McNamara, P.C. | Other | Acknowledgement Letter/Receipt | 2026-05-27T04:00:00Z | 2026 | 5 | 2026-05-27T04:00:00Z | 2026-05-27T22:44:26Z | 0 | 0 | 09000064b92f463b |
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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;