documents
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)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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| FDA-2024-P-2778-0010 | FDA | None FDA-2024-P-2778 | Attachment 4 - Draft Guidance on Chlorzoxazone | Supporting & Related Material | Background Material | 2024-07-01T04:00:00Z | 2024 | 7 | 2024-07-01T17:47:08Z | 0 | 0 | 09000064865d5493 |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;