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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

13 rows where docket_id = "FDA-2024-P-2778" 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 2

  • Supporting & Related Material 8
  • Other 5

posted_year 1

  • 2024 13

agency_id 1

  • FDA 13
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2778-0013 FDA None FDA-2024-P-2778 Final Response Letter from FDA CDER to Pharmobedient Consulting, LLC Other Denial of Petition 2024-12-26T05:00:00Z 2024 12 2024-12-26T05:00:00Z   2024-12-26T17:30:38Z   0 0 090000648688c866
FDA-2024-P-2778-0012 FDA None FDA-2024-P-2778 Completeness Assessment Correspondence Other Assessment Document or Analysis 2024-07-10T04:00:00Z 2024 7 2024-07-10T04:00:00Z   2024-07-10T18:54:18Z   0 0 09000064865e6919
FDA-2024-P-2778-0010 FDA None FDA-2024-P-2778 Attachment 4 - Draft Guidance on Chlorzoxazone Supporting & Related Material Background Material 2024-07-01T04:00:00Z 2024 7     2024-07-01T17:47:08Z   0 0 09000064865d5493
FDA-2024-P-2778-0008 FDA None FDA-2024-P-2778 Attachment 1 - Orange Book for PARAFON FORTE DSC Supporting & Related Material Background Material 2024-07-01T04:00:00Z 2024 7     2024-07-01T17:46:59Z   0 0 09000064865d5491
FDA-2024-P-2778-0009 FDA None FDA-2024-P-2778 Attachment 2 - RS under ANDA 089859 Revised 7 2019 Supporting & Related Material Background Material 2024-07-01T04:00:00Z 2024 7     2024-07-01T17:47:03Z   0 0 09000064865d5492
FDA-2024-P-2778-0011 FDA None FDA-2024-P-2778 Attachment 5 - Chlorzoxazone Orally Disintegrating Tablets Supporting & Related Material Background Material 2024-07-01T04:00:00Z 2024 7     2024-07-01T17:47:14Z   0 0 09000064865d5494
FDA-2024-P-2778-0007 FDA None FDA-2024-P-2778 Suitability Petition Amendment from Pharmobedient Consulting LLC Other Amendment 2024-07-01T04:00:00Z 2024 7 2024-07-01T04:00:00Z   2024-07-01T17:46:52Z   0 0 09000064865d5630
FDA-2024-P-2778-0002 FDA None FDA-2024-P-2778 Acknowledgment Letter from FDA DMS to Pharmobedient Consulting, LLC Other Acknowledgement Letter/Receipt 2024-06-11T04:00:00Z 2024 6 2024-06-11T04:00:00Z   2024-06-11T14:51:05Z   0 0 09000064865a7a6e
FDA-2024-P-2778-0006 FDA None FDA-2024-P-2778 Attachment 4 - FDA BE guidance PSG_011529 Supporting & Related Material Background Material 2024-06-11T04:00:00Z 2024 6     2024-06-11T14:51:53Z   0 0 09000064865a7dd5
FDA-2024-P-2778-0005 FDA None FDA-2024-P-2778 Attachment 3 - Chloroxazone PI-ODT Revision-06.07.24 Supporting & Related Material Background Material 2024-06-11T04:00:00Z 2024 6     2024-06-11T14:51:38Z   0 0 09000064865a7dd3
FDA-2024-P-2778-0004 FDA None FDA-2024-P-2778 Attachment 2 - RS Labeling Supporting & Related Material Background Material 2024-06-11T04:00:00Z 2024 6     2024-06-11T14:51:29Z   0 0 09000064865a7dd2
FDA-2024-P-2778-0001 FDA None FDA-2024-P-2778 Suitability Petition from Pharmobedient Consulting, LLC Other Petition(s) 2024-06-11T04:00:00Z 2024 6 2024-06-11T04:00:00Z   2024-12-26T15:42:08Z   0 0 09000064865a7a6d
FDA-2024-P-2778-0003 FDA None FDA-2024-P-2778 Attachment 1 -Orange Book - Paraforn Forte DSC Supporting & Related Material Background Material 2024-06-11T04:00:00Z 2024 6     2024-06-11T14:51:19Z   0 0 09000064865a7dcd

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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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