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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 agency_id = "FDA" and docket_id = "FDA-2006-P-0018" sorted by posted_date descending

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posted_year 2

  • 2006 27
  • 2015 1

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  • Supporting & Related Material 20
  • Other 8

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2006-P-0018-0044 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 Citizen Petition Partial Approval and Denial Response from FDA CDER to State of Wisconsin (Department of Justice) Other Partial Petition Approval and Denial 2015-12-30T05:00:00Z 2015 12 2015-12-30T05:00:00Z   2015-12-30T19:38:40Z   0 0 0900006481ddc00b
FDA-2006-P-0018-0043 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 FDA/CDER to Wisconsin Department of Justice Other LET-Letter 2006-11-21T05:00:00Z 2006 11     2008-04-11T23:16:42Z   0 0 0900006480441a19
FDA-2006-P-0018-0026 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin, Department of Justice Other SUP-Supplement 2006-07-25T04:00:00Z 2006 7     2008-04-11T23:16:57Z   0 0 0900006480441707
FDA-2006-P-0018-0024 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin, Department of Justice Other SUP-Supplement 2006-07-25T04:00:00Z 2006 7     2008-04-11T23:16:52Z   0 0 0900006480441705
FDA-2006-P-0018-0025 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin, Department of Justice - Shipping Label Supporting & Related Material   2006-07-25T00:00:00Z 2006 7     2008-06-24T20:31:30Z   0 1 0900006480441706
FDA-2006-P-0018-0023 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Letter 1 Acknowledging FDA's acknowledging receipt of petition Other LET-Letter 2006-06-21T04:00:00Z 2006 6     2008-06-24T20:45:00Z   0 0 0900006480441704
FDA-2006-P-0018-0022 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Envelope Supporting & Related Material   2006-06-21T00:00:00Z 2006 6     2008-06-24T20:26:20Z   0 1 0900006480441703
FDA-2006-P-0018-0020 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 HFA-305 to Wisconsin Department of Justice Other ACK-Acknowledgement Letter 2006-05-31T04:00:00Z 2006 5     2008-06-24T20:41:28Z   0 0 0900006480441701
FDA-2006-P-0018-0021 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 FDA/DDM Acknowledgement Letter to Wisconsin Department of Justice - Other ACK-Acknowledgement Letter 2006-05-31T04:00:00Z 2006 5     2008-06-24T20:39:47Z   0 0 0900006480441702
FDA-2006-P-0018-0015 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab K - "(Legis. Fiscal Bureau 2005)" refers to Wisconsin Legislative Fiscal Bureau, "Medical Assistance, Badger Care, Senior Care and Related Programs," Informational Paper 43 (January 2005), http://www.legis.state.wi.us/lfb/Informationalpapers/43.pdf Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:59:49Z   0 0 09000064804416fc
FDA-2006-P-0018-0004 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Citizen Petition Other CP-Citizen Petition 2006-05-26T04:00:00Z 2006 5     2008-06-24T18:44:44Z   0 0 09000064804416f1
FDA-2006-P-0018-0010 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab D - "(Executive Office 2002)" refers to Drug Availability Steering Committee, Executive Office of the President, "Drug Availability Estimates in the United States," NCJ 197107 (December 2002) Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:43:23Z   0 0 09000064804416f7
FDA-2006-P-0018-0012 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic Tab G - "(GAO 2005)" refers to GAO, Food and Drug Administration: Decision Process to Deny Initial Application for Over-the Counter Marketing of the Emergency Contraceptive Drug Plan Was Unusual, (GAO-06-109, November 2005) Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:48:22Z   0 0 09000064804416f9
FDA-2006-P-0018-0007 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab A - "Emergency Contraception" an update to previous study by New York State Office of the State Comptroller Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:30:15Z   0 0 09000064804416f4
FDA-2006-P-0018-0008 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab B - Center for Reproductive Rights briefing paper Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:34:07Z   0 0 09000064804416f5
FDA-2006-P-0018-0016 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab L - "(Mayo 2006)" refers to Mayo Clinic Staff, "Acetaminophen: Watch dosage for children," (February 10, 2006), http://www.mayoclinic.com/health/acetaminophen/HO00002 Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T20:12:46Z   0 0 09000064804416fd
FDA-2006-P-0018-0011 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab I - "(Guttmacher U.S. 2004), refers to Guttmacher Institute, "U.S. Teenage Pregnancy Statistics: Overall Trends by Race and Ethnicity and State-by-State Information," (February 19, 2004) Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:46:24Z   0 0 09000064804416f8
FDA-2006-P-0018-0006 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Documents cited in, and attached to, Citizen Petition Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:24:14Z   0 0 09000064804416f3
FDA-2006-P-0018-0019 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tabl O - "(WisDHFS)" refers to Bureau of Health Information, Wisconsin Department of Health and Family Services, "Fact Sheet on Wisconsin Women's Health and Demography" (May 2004) Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T20:23:29Z   0 0 0900006480441700
FDA-2006-P-0018-0005 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Citatioins to documents cited in Citizen Petition Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:22:19Z   0 0 09000064804416f2
FDA-2006-P-0018-0002 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab F - Carton Text - Plan B (levonorgestrel) tablets Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:09:23Z   0 0 09000064804416ee
FDA-2006-P-0018-0001 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab E - Notice Supporting & Related Material CP-Citizen Petition (Supporting & Related Materials) 2006-05-26T04:00:00Z 2006 5     2008-06-24T19:16:54Z   0 0 09000064804416ec
FDA-2006-P-0018-0013 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab H - "(Guttmacher State 2004)" refers to Guttmacher Institute, "State Facts About Abortion: Wisconsin," (May, 2004), http://www.guttmacher.org/pubs/sfaa/wisconsin.html Supporting & Related Material   2006-05-26T00:00:00Z 2006 5     2008-06-24T19:51:07Z   0 1 09000064804416fa
FDA-2006-P-0018-0014 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab J - "(Guttmacher U.S. 2004), refers to Guttmacher Institute, "U.S. Teenage Pregnancy Statistics: Overall Trends by Race and Ethnicity and State-by-State Information," (February 19, 2004), http://www.guttmacher.org/pubs/state_pregancy_trends.pdf Supporting & Related Material   2006-05-26T00:00:00Z 2006 5     2008-06-24T19:53:18Z   0 1 09000064804416fb
FDA-2006-P-0018-0017 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab M - "(Raymond 2002)" refers to Raymond, EG, Dalebout, SM & Camp, SI, "Comprehension of a Prototype Over-the-Counter Label for an Emergency Contraceptive Pill Product," 100 Obstet Gynecol 342-349 (No. 2, August 2002) Supporting & Related Material   2006-05-26T00:00:00Z 2006 5     2008-06-24T20:17:49Z   0 1 09000064804416fe
FDA-2006-P-0018-0003 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab P - Article Supporting & Related Material   2006-05-26T00:00:00Z 2006 5     2008-06-24T19:20:14Z   0 1 09000064804416f0
FDA-2006-P-0018-0018 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Tab N - "(Raymond 2003)" refers to Raymond, E, Chen, P & Dalebout, S, "'Actual Use' Study of Emergency Contraceptive Pills Provided in a Simulated Over-the-Counter Manner," 102 Obstet Gynecol 17-23 (No. 1, July 2003) Supporting & Related Material   2006-05-26T00:00:00Z 2006 5     2008-06-24T20:22:01Z   0 1 09000064804416ff
FDA-2006-P-0018-0009 FDA Switch Plan B and equivalent EC drugs from precription -only to OTC status without age restrictions, exempt from prescription-dispensing requirement any new drug eligible for filing an ANDA because of its equivalence to Plan B FDA-2006-P-0018 State of Wisconsin Department of Justic - Published Material Supporting & Related Material   2006-05-26T00:00:00Z 2006 5     2008-06-24T19:41:04Z   0 1 09000064804416f6

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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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