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-2022-P-0614" 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)

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2022-P-0614-0007 FDA None FDA-2022-P-0614 Response Letter from FDA CDER to Yichang Humanwell Pharmaceuticals, LLC Other Response(s) 2022-12-21T05:00:00Z 2022 12 2022-12-21T05:00:00Z   2022-12-21T18:21:19Z   0 0 0900006485549f61
FDA-2022-P-0614-0006 FDA None FDA-2022-P-0614 Determination That ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice Determinations 2022-12-21T05:00:00Z 2022 12 2022-12-21T05:00:00Z   2022-12-21T15:58:45Z 2022-27647 0 0 0900006485548d58
FDA-2022-P-0614-0005 FDA None FDA-2022-P-0614 Interim Response Letter from FDA CDER to Yichang Humanwell Pharmaceuticals LLC Other Letter(s) 2022-10-26T04:00:00Z 2022 10 2022-10-26T04:00:00Z   2022-10-26T12:25:39Z   0 0 090000648545ccbf
FDA-2022-P-0614-0004 FDA None FDA-2022-P-0614 Attachment 2 - Cumulative Supplement of the Orange Book - July 2019 - re: Citizen Petition from Yichang Humanwell Pharmaceutical Co. Ltd. Supporting & Related Material Background Material 2022-04-19T04:00:00Z 2022 4     2022-04-19T17:43:37Z   0 0 0900006485023c43
FDA-2022-P-0614-0002 FDA None FDA-2022-P-0614 Acknowledgment Letter from FDA DMS to Yichang Humanwell Pharmaceutical Co. Ltd. Other Acknowledgement Letter/Receipt 2022-04-19T04:00:00Z 2022 4 2022-04-19T04:00:00Z   2022-04-19T17:43:20Z   0 0 0900006485023f43
FDA-2022-P-0614-0001 FDA None FDA-2022-P-0614 Citizen Petition from Yichang Humanwell Pharmaceutical Co., Ltd. Other Citizen Petition 2022-04-19T04:00:00Z 2022 4 2022-04-19T04:00:00Z   2022-12-21T17:09:54Z   0 0 0900006485023ad5
FDA-2022-P-0614-0003 FDA None FDA-2022-P-0614 Attachment 1- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations - re: Citizen Petition from Yichang Humanwell Pharmaceutical Co. Ltd. Supporting & Related Material Background Material 2022-04-19T04:00:00Z 2022 4     2022-04-19T17:43:30Z   0 0 0900006485023c3c

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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;