documents

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

9 rows where docket_id = "FDA-2024-P-3571" 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)

document_type 2

posted_year 1

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2024-P-3571-0009 FDA None FDA-2024-P-3571 Final Response Letter from FDA CDER to Premier Consulting Other Approval 2024-12-26T05:00:00Z 2024 12 2024-12-26T05:00:00Z   2024-12-26T18:29:17Z   0 0 090000648688c4f5
FDA-2024-P-3571-0008 FDA None FDA-2024-P-3571 Amendment to Suitability Petition from Premier Consulting Other Amendment 2024-12-02T05:00:00Z 2024 12 2024-12-02T05:00:00Z   2024-12-02T19:02:50Z   0 0 0900006486844a93
FDA-2024-P-3571-0007 FDA None FDA-2024-P-3571 Amendment to Suitability Petition from Premier Consulting Other Amendment 2024-11-13T05:00:00Z 2024 11 2024-11-13T05:00:00Z   2024-11-13T15:18:24Z   0 0 0900006486812ab5
FDA-2024-P-3571-0006 FDA None FDA-2024-P-3571 Completeness Assessment Correspondence Other Assessment Document or Analysis 2024-08-16T04:00:00Z 2024 8 2024-08-16T04:00:00Z   2024-08-16T15:23:47Z   0 0 090000648664df09
FDA-2024-P-3571-0004 FDA None FDA-2024-P-3571 Appendix 2 - FDA Orange Book – LOTREL (accessed 18 June 2024) Supporting & Related Material Background Material 2024-07-30T04:00:00Z 2024 7     2024-07-30T17:31:41Z   0 0 090000648660e567
FDA-2024-P-3571-0005 FDA None FDA-2024-P-3571 Appendix 3 - Proposed Draft Labeling for the Amlodipine and Benazepril hydrochloride Oral Liquid Product Supporting & Related Material Background Material 2024-07-30T04:00:00Z 2024 7     2024-07-30T17:31:48Z   0 0 090000648660e568
FDA-2024-P-3571-0002 FDA None FDA-2024-P-3571 Acknowledgment Letter from FDA DMS to Premier Consulting Other Acknowledgement Letter/Receipt 2024-07-30T04:00:00Z 2024 7 2024-07-30T04:00:00Z   2024-07-30T17:31:24Z   0 0 090000648660e29e
FDA-2024-P-3571-0001 FDA None FDA-2024-P-3571 Suitability Petition from Premier Consulting Other Petition(s) 2024-07-30T04:00:00Z 2024 7 2024-07-30T04:00:00Z   2024-12-26T18:08:50Z   0 0 090000648660e29c
FDA-2024-P-3571-0003 FDA None FDA-2024-P-3571 Appendix 1 - Approved Product Labeling – LOTREL Supporting & Related Material Background Material 2024-07-30T04:00:00Z 2024 7     2024-07-30T17:31:36Z   0 0 090000648660e566

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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;