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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

28 rows where docket_id = "FDA-1975-N-0013" sorted by posted_date descending

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posted_year 4

  • 2009 25
  • 1998 1
  • 2007 1
  • 2010 1

document_type 4

  • Supporting & Related Material 17
  • Other 8
  • Notice 2
  • Proposed Rule 1

agency_id 1

  • FDA 28
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1975-N-0013-0042 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 FDA to Buchanan Ingersoll & Rooney PC - Petition Denial Other PDN-Petition Denial 2010-04-08T04:00:00Z 2010 4 2010-04-08T04:00:00Z   2013-08-11T01:33:43Z   0 0 0900006480ad362d
FDA-1975-N-0013-0035 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab J - "Alcavis International, Inc. Letter to FDA, February 10, 2004" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:21:02Z   0 0 0900006480a4e3f4
FDA-1975-N-0013-0025 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Request for Hearing from Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) Other Request for Hearing 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2017-11-13T19:00:29Z   0 0 0900006480a4e166
FDA-1975-N-0013-0031 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab F - "68 Federal Register 3203 Dated May 29, 2003" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:19:17Z   0 0 0900006480a4e3ef
FDA-1975-N-0013-0032 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab G - "Alcavis International, Inc. Letter to FDA, June 5 2003" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:19:43Z   0 0 0900006480a4e3f0
FDA-1975-N-0013-0036 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab K - "Alcavis International, Inc. Letter to FDA, March 15, 2004" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:21:59Z   0 0 0900006480a4e6e4
FDA-1975-N-0013-0037 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab L - "Alcavis International, Inc. (Alston & Bird, LLP) Letter to FDA, July 15, 2005" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:22:19Z   0 0 0900006480a4e6e5
FDA-1975-N-0013-0041 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Index of Select Scientific References Cited - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-16T23:44:27Z   0 0 0900006480a4e6ea
FDA-1975-N-0013-0034 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab I - "Alcavis International, Inc. Letter to FDA, July 1, 2003" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:20:36Z   0 0 0900006480a4e3f2
FDA-1975-N-0013-0040 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab O - "FDA/CDER Response to Alcavis International, Inc. - Petition Denial, April 24, 2009" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:24:07Z   0 0 0900006480a4e6e8
FDA-1975-N-0013-0024 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Citizen Petition from Amuchina International, Inc. Other Citizen Petition 2009-12-16T05:00:00Z 2009 12 2009-12-16T05:00:00Z   2017-11-16T14:57:17Z   0 0 09000064805c1daa
FDA-1975-N-0013-0027 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab B - "Citizen Petition Filed by Alcavis, International, Inc., February 20, 2002" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:17:20Z   0 0 0900006480a4e1b5
FDA-1975-N-0013-0028 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab C - "FDA Response to Alcavis International, Inc., November 14, 2002" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:17:51Z   0 0 0900006480a4e1d2
FDA-1975-N-0013-0029 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab D - "Alcavis International, Inc. Letter to FDA, December 20, 2002" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:18:18Z   0 0 0900006480a4e1e9
FDA-1975-N-0013-0033 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab H - "Alcavis International, Inc. Letter to FDA, June 17, 2003" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:20:08Z   0 0 0900006480a4e3f1
FDA-1975-N-0013-0043 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tabs 1 through 12 - "Select Scientific References Cited" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material Background Material 2009-12-16T05:00:00Z 2009 12     2017-11-16T20:06:03Z   0 0 0900006480a4e7e1
FDA-1975-N-0013-0030 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab E - "Alcavis International, Inc. Letter to FDA, March 18, 2003" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:18:40Z   0 0 0900006480a4e3ee
FDA-1975-N-0013-0039 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab N - "Alcavis International, Inc. (Alston & Bird, LLP) Supplement, February 6, 2009" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:23:37Z   0 0 0900006480a4e6e7
FDA-1975-N-0013-0038 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab M - "Alcavis International, Inc. (Alston & Bird, LLP) Letter to FDA, October 4, 2006" - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:22:58Z   0 0 0900006480a4e6e6
FDA-1975-N-0013-0026 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Tab A - "Citizen Petition Filed by Amuchina, International, Inc. (Atkin, Gump, Strauss, Hauer & Feld), January 29, 1999 - [Alcavis International, Inc. (Buchanan, Ingersoll & Rooney, PC) - Request for Hearing] re FDA-1975-N-0013-0025 Supporting & Related Material HER-Request for Hearing (Supporting and Related Material) 2009-12-16T05:00:00Z 2009 12     2009-12-22T20:16:53Z   0 0 0900006480a4e16c
FDA-1975-N-0013-0023 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Petition Denial from FDA/CDER to Alcavis International, Inc. Other Denial of Petition 2009-04-24T04:00:00Z 2009 4 2009-04-24T04:00:00Z   2017-11-02T18:36:20Z   0 0 0900006480969491
FDA-1975-N-0013-0022 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Letter from Alcavis International Inc. to FDA Other Letter(s) 2009-03-04T05:00:00Z 2009 3 2009-03-04T05:00:00Z   2017-10-05T19:35:24Z   0 0 09000064808eaa2a
FDA-1975-N-0013-0021 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Letter from Alcavis International Inc. to FDA Other Letter(s) 2009-03-04T05:00:00Z 2009 3 2009-03-04T05:00:00Z   2017-10-05T19:36:58Z   0 0 09000064808ea462
FDA-1975-N-0013-0020 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Alcavis HDC, LLC (Alston & Bird, LLP) - Supplement Petition [re CP4] Other SUP-Supplement 2009-02-10T05:00:00Z 2009 2 2009-02-10T05:00:00Z   2013-07-27T22:37:51Z   0 0 090000648084a33f
FDA-1975-N-0013-0015 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for First Aid Antiseptic Drug Products Notice Correction 2009-01-13T05:00:00Z 2009 1 2009-01-13T05:00:00Z 1992-01-22T04:59:59Z 2017-11-02T15:03:55Z   0 0 09000064805c1d4d
FDA-1975-N-0013-0005 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for First Aid Antiseptic Drug Products Proposed Rule Notice of Proposed Rulemaking (NPRM) 2009-01-12T05:00:00Z 2009 1 2009-01-12T05:00:00Z 1992-01-22T04:59:59Z 2017-10-03T17:08:32Z FR Doc. 91-17107 0 0 09000064805c1d3d
FDA-1975-N-0013-0004 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Acknowledgement Letter from FDA/DDM to Century Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2007-04-10T04:00:00Z 2007 4     2017-11-16T14:18:21Z   0 0 09000064805c1dca
FDA-1975-N-0013-0001 FDA First Aid; Topical Antimicrobial Drug Products for Over-the-Counter (OTC) Human Use (OPEN) FDA-1975-N-0013 Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients Notice Notice of Final Rule 1998-04-22T04:00:00Z 1998 4     2017-11-16T02:02:43Z 98–10578 0 0 09000064805c1d3c

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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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