documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
7 rows where docket_id = "FDA-2025-P-2077" sorted by posted_date descending
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Suggested facets: 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2025-P-2077-0007 | FDA | None FDA-2025-P-2077 | Response Letter | Other | Letter(s) | 2025-12-31T05:00:00Z | 2025 | 12 | 2025-12-31T05:00:00Z | 2025-12-31T19:22:07Z | 0 | 0 | 09000064b9111c53 | ||
| FDA-2025-P-2077-0006 | FDA | None FDA-2025-P-2077 | Completeness Assessment Correspondence | Other | Assessment Document or Analysis | 2025-07-16T04:00:00Z | 2025 | 7 | 2025-07-16T04:00:00Z | 2025-07-16T18:34:06Z | 0 | 0 | 09000064b8e77d29 | ||
| FDA-2025-P-2077-0002 | FDA | None FDA-2025-P-2077 | Acknowledgment Letter from FDA DMB to Premier Research | Other | Acknowledgement Letter/Receipt | 2025-07-01T04:00:00Z | 2025 | 7 | 2025-07-01T04:00:00Z | 2025-07-01T19:56:25Z | 0 | 0 | 09000064b8e4b993 | ||
| FDA-2025-P-2077-0001 | FDA | None FDA-2025-P-2077 | Suitability Petition from Premier Research | Other | Petition(s) | 2025-07-01T04:00:00Z | 2025 | 7 | 2025-07-01T04:00:00Z | 2026-02-27T01:30:38Z | 0 | 0 | 09000064b8e4b990 | ||
| FDA-2025-P-2077-0003 | FDA | None FDA-2025-P-2077 | Appendix 1 - Approved Product Labeling - Prozac | Supporting & Related Material | Background Material | 2025-07-01T04:00:00Z | 2025 | 7 | 2025-07-01T19:56:35Z | 0 | 0 | 09000064b8e4bd79 | |||
| FDA-2025-P-2077-0004 | FDA | None FDA-2025-P-2077 | Appendix 2 - FDA Orange Book - Prozac | Supporting & Related Material | Background Material | 2025-07-01T04:00:00Z | 2025 | 7 | 2025-07-01T19:56:45Z | 0 | 0 | 09000064b8e4bd7a | |||
| FDA-2025-P-2077-0005 | FDA | None FDA-2025-P-2077 | Appendix 3 - Proposed Draft Labeling for the Fluoxetine Hydrochloride Capsules | Supporting & Related Material | Background Material | 2025-07-01T04:00:00Z | 2025 | 7 | 2025-07-01T19:56:53Z | 0 | 0 | 09000064b8e4bd7b |
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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;