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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 agency_id = "FDA" and docket_id = "FDA-1999-P-4073" sorted by posted_date descending

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

document_type 2

  • Other 4
  • Supporting & Related Material 3

posted_year 1

  • 2017 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1999-P-4073-0004 FDA ANDA for Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50mg FDA-1999-P-4073 Attachment C Side by Side Labeling Comparison of DARVOCET N-100 and Propoxyphene and Acetaminophen Tablets/Capsules 50mg/500mg re: Citizen Petition from Mikart, Inc. Supporting & Related Material Background Material 2017-07-25T04:00:00Z 2017 7     2017-07-25T14:23:41Z   0 0 090000648295f33f
FDA-1999-P-4073-0007 FDA ANDA for Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50mg FDA-1999-P-4073 Petition Denial Response Letter from FDA CDER to Mikart, Inc. Other Denial of Petition 2017-07-25T04:00:00Z 2017 7 2017-07-25T04:00:00Z   2017-07-25T14:34:07Z   0 0 09000064804f5e6c
FDA-1999-P-4073-0005 FDA ANDA for Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50mg FDA-1999-P-4073 Acknowledgment Letter from FDA DDM to Mikart, Inc. Other Acknowledgement Letter/Receipt 2017-07-25T04:00:00Z 2017 7 2017-07-25T04:00:00Z   2017-07-25T14:27:15Z   0 0 09000064804f5e6a
FDA-1999-P-4073-0006 FDA ANDA for Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50mg FDA-1999-P-4073 Correction from Mikart, Inc. Other Correction(s) 2017-07-25T04:00:00Z 2017 7 2017-07-25T04:00:00Z   2017-07-25T14:30:54Z   0 0 09000064804f5e6b
FDA-1999-P-4073-0002 FDA ANDA for Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50mg FDA-1999-P-4073 Attachment A Labeling for DARVOCET-N 100 re: Citizen Petition from Mikart, Inc. Supporting & Related Material Background Material 2017-07-25T04:00:00Z 2017 7     2017-07-25T14:21:22Z   0 0 090000648295f33d
FDA-1999-P-4073-0003 FDA ANDA for Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50mg FDA-1999-P-4073 Attachment B Proposed Labeling for Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50mg/500mg re: Citizen Petition from Mikart, Inc. Supporting & Related Material Background Material 2017-07-25T04:00:00Z 2017 7     2017-07-25T14:21:07Z   0 0 090000648295f33e
FDA-1999-P-4073-0001 FDA ANDA for Propoxyphene Napsylate and Acetaminophen Tablets/Capsules 50mg FDA-1999-P-4073 Citizen Petition from Mikart, Inc. Other Citizen Petition 2017-07-24T04:00:00Z 2017 7 1999-10-26T04:00:00Z   2017-07-24T18:40:43Z   0 0 09000064804f5e69

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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);
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