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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-2021-P-0375" 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)

document_type 3

  • Other 4
  • Supporting & Related Material 2
  • Notice 1

posted_year 1

  • 2021 7

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2021-P-0375-0007 FDA None FDA-2021-P-0375 Agency Approval Letter from FDA CDER to Celerity Pharmaceuticals LLC Other Agency Response 2021-12-22T05:00:00Z 2021 12 2021-12-22T05:00:00Z   2021-12-22T20:28:26Z   0 0 0900006484ee6f46
FDA-2021-P-0375-0006 FDA None FDA-2021-P-0375 Determination That Alcohol and Dextrose Injection, 5 Milliliters/100 Milliliters, 5 Grams/100 Milliliters; and 10 Milliliters/100 Milliliters, 5 Grams/100 Milliliters, Were Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2021-12-22T05:00:00Z 2021 12 2021-12-22T05:00:00Z   2021-12-22T13:26:27Z 2021-27696 0 0 0900006484ee0a01
FDA-2021-P-0375-0005 FDA None FDA-2021-P-0375 Interim Response Letter from FDA CDER to Celerity Pharmaceuticals, LLC Other Response(s) 2021-10-07T04:00:00Z 2021 10 2021-10-07T04:00:00Z   2021-10-07T17:12:31Z   0 0 0900006484dbe91e
FDA-2021-P-0375-0001 FDA None FDA-2021-P-0375 Citizen Petition from Celerity Pharmaceuticals LLC Other Citizen Petition 2021-04-12T04:00:00Z 2021 4 2021-04-12T04:00:00Z   2021-12-22T20:28:43Z   0 0 0900006484aa34cd
FDA-2021-P-0375-0002 FDA None FDA-2021-P-0375 Acknowledgement Letter from FDA DMS to Celerity Pharmaceuticals LLC from FDA DMS Other Acknowledgement Letter/Receipt 2021-04-12T04:00:00Z 2021 4 2021-04-12T04:00:00Z   2021-04-12T19:23:17Z   0 0 0900006484aa3e35
FDA-2021-P-0375-0003 FDA None FDA-2021-P-0375 Attachment 2 re: Citizen Petition from Celerity Pharmaceuticals LLC. Supporting & Related Material Background Material 2021-04-12T04:00:00Z 2021 4     2021-04-12T19:23:32Z   0 0 0900006484aa3e4e
FDA-2021-P-0375-0004 FDA None FDA-2021-P-0375 Attachment 1- Orange Book RE: Citizen Petition from Celerity Pharmaceuticals LLC. Supporting & Related Material Background Material 2021-04-12T04:00:00Z 2021 4     2021-04-12T19:23:37Z   0 0 0900006484aa3e5e

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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;
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