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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", docket_id = "FDA-1999-P-0043" and posted_year = 2017 sorted by posted_date descending

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

document_type 2

  • Supporting & Related Material 4
  • Other 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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0043-0008 FDA Suitability Petition Propoxyphene Napsylate/Acetaminophen 100mg/325mg as ANDA-CLOSED FDA-1999-P-0043 Petition Denial Response from FDA CDER to Mikart Inc. Other Denial of Petition 2017-04-26T04:00:00Z 2017 4 2017-04-26T04:00:00Z   2017-04-26T18:33:49Z   0 0 09000064804a5f45
FDA-1999-P-0043-0003 FDA Suitability Petition Propoxyphene Napsylate/Acetaminophen 100mg/325mg as ANDA-CLOSED FDA-1999-P-0043 Attachment A Label Description of Darvocet-N 50 and Darvocet-N 100 re: Citizen Petition from Mikart, Inc. Supporting & Related Material Background Material 2017-04-26T04:00:00Z 2017 4     2017-04-26T18:00:05Z   0 0 09000064804a5f40
FDA-1999-P-0043-0005 FDA Suitability Petition Propoxyphene Napsylate/Acetaminophen 100mg/325mg as ANDA-CLOSED FDA-1999-P-0043 Attachment C Product Comparison with Propoxyphene Napsylate and Acetaminophen Tablets and Darvocet-N re: Citizen Petition from Mikart, Inc. Supporting & Related Material Background Material 2017-04-26T04:00:00Z 2017 4     2017-04-26T18:10:30Z   0 0 090000648257ba7a
FDA-1999-P-0043-0007 FDA Suitability Petition Propoxyphene Napsylate/Acetaminophen 100mg/325mg as ANDA-CLOSED FDA-1999-P-0043 Petition Approval Response from FDA CDER to Mikart Inc. Other Approval 2017-04-26T04:00:00Z 2017 4 2017-04-26T04:00:00Z   2017-04-26T18:30:15Z   0 0 09000064804a5f44
FDA-1999-P-0043-0002 FDA Suitability Petition Propoxyphene Napsylate/Acetaminophen 100mg/325mg as ANDA-CLOSED FDA-1999-P-0043 Citizen Petition from Mikart, Inc. Other Citizen Petition 2017-04-26T04:00:00Z 2017 4 1999-07-08T04:00:00Z   2017-04-26T17:59:31Z   0 0 09000064804a5f3f
FDA-1999-P-0043-0004 FDA Suitability Petition Propoxyphene Napsylate/Acetaminophen 100mg/325mg as ANDA-CLOSED FDA-1999-P-0043 Attachment B Label Description of Propoxyphene Napsylate and Acetaminophen re: Citizen Petition from Mikart, Inc. Supporting & Related Material Background Material 2017-04-26T04:00:00Z 2017 4     2017-04-26T18:03:55Z   0 0 090000648257ba79
FDA-1999-P-0043-0006 FDA Suitability Petition Propoxyphene Napsylate/Acetaminophen 100mg/325mg as ANDA-CLOSED FDA-1999-P-0043 Supplement from Mikart, Inc. Supporting & Related Material Background Material 2017-04-26T04:00:00Z 2017 4     2017-04-26T18:18:15Z   0 0 09000064804a5f41

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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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