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

7 rows where docket_id = "FDA-2024-P-4163" sorted by posted_date descending

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Suggested facets: posted_date, posted_month, comment_start_date, posted_date (date), comment_start_date (date), last_modified (date)

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-4163-0006 FDA None FDA-2024-P-4163 Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction Notice Correction 2024-11-20T05:00:00Z 2024 11 2024-11-20T05:00:00Z   2024-11-20T14:53:38Z 2024-27082 0 0 0900006486829fe2
FDA-2024-P-4163-0007 FDA None FDA-2024-P-4163 Final Response Letter from FDA CDER to Aizant Drug Research Solutions Private Limited Other Denial of Petition 2024-11-20T05:00:00Z 2024 11 2024-11-20T05:00:00Z   2024-11-20T20:50:48Z   0 0 090000648682ad8b
FDA-2024-P-4163-0005 FDA None FDA-2024-P-4163 Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2024-10-16T04:00:00Z 2024 10 2024-10-16T04:00:00Z   2024-10-16T13:53:16Z 2024-23811 0 0 09000064867d07eb
FDA-2024-P-4163-0004 FDA None FDA-2024-P-4163 Amendment from Aizant Drug Research Solutions Private Limited Other Amendment 2024-09-04T04:00:00Z 2024 9 2024-09-04T04:00:00Z   2024-09-04T21:29:05Z   0 0 09000064866bef58
FDA-2024-P-4163-0002 FDA None FDA-2024-P-4163 Acknowledgement Letter from FDA DMS to Aizant Drug Research Solutions Private Limited Other Acknowledgement Letter/Receipt 2024-09-03T04:00:00Z 2024 9 2024-09-03T04:00:00Z   2024-09-03T17:26:45Z   0 0 09000064866bdf25
FDA-2024-P-4163-0001 FDA None FDA-2024-P-4163 Citizen Petition from Aizant Drug Research Solutions Private Limited Other Citizen Petition 2024-09-03T04:00:00Z 2024 9 2024-09-03T04:00:00Z   2024-11-20T19:58:42Z   0 0 09000064866bdf15
FDA-2024-P-4163-0003 FDA None FDA-2024-P-4163 Attachment 1 Supporting & Related Material Background Material 2024-09-03T04:00:00Z 2024 9     2024-09-03T17:26:49Z   0 0 09000064866bdf2b

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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;