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55 rows where docket_id = "FDA-1975-N-0012" and posted_year = 2020 sorted by posted_date descending

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  • 2020 · 55 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0012-0835 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 The American CIeaning Institute Progress Report Other Report 2020-12-04T05:00:00Z 2020 12 2020-12-04T05:00:00Z   2020-12-04T16:11:45Z   0 0 0900006484986dd3
FDA-1975-N-0012-0834 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 FDA Updated Response to ACI July 2020 Progress Report (ethanol bzk pmcx bzec pi) Other Letter(s) 2020-11-23T05:00:00Z 2020 11 2020-11-23T05:00:00Z   2020-11-23T13:04:07Z   0 0 0900006484970492
FDA-1975-N-0012-0833 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 FDA Response to ACI July 2020 Progress Report (ethanol bzk pmcx bzec pi) Other Agency Response 2020-11-20T05:00:00Z 2020 11 2020-11-20T05:00:00Z   2020-11-20T14:36:43Z   0 0 090000648496ca5e
FDA-1975-N-0012-0832 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 ACI Advice November 18 2020 Other Letter(s) 2020-11-20T05:00:00Z 2020 11 2020-11-20T05:00:00Z   2020-11-20T14:31:06Z   0 0 090000648496c57e
FDA-1975-N-0012-0831 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 ACI BZT Monograph Meeting Minutes Written Responses Supporting & Related Material Meeting Materials 2020-10-06T04:00:00Z 2020 10     2020-10-06T14:24:05Z   0 0 09000064848be3df
FDA-1975-N-0012-0830 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Meeting Minutes for Lonza & Henkel’s benzalkonium chloride consumer antiseptic handwash July 30 2020 Other Minutes 2020-08-26T04:00:00Z 2020 8 2020-08-26T04:00:00Z   2020-08-26T13:57:23Z   0 0 09000064848202db
FDA-1975-N-0012-0812 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. APPROVED BY INTEGREVIEW IRB OCTOBER 25, 2019 THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL jr/9-27-19 rss/10-25-19 INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDYre Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T18:59:45Z   0 0 0900006484717944
FDA-1975-N-0012-0829 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Table 14.1.1: Summary of Subject Enrollment and Disposition re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:15:29Z   0 0 0900006484718b64
FDA-1975-N-0012-0827 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Henkel Corporation, Inc. Lonza Inc. A Pilot Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin with Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:15:09Z   0 0 0900006484718b62
FDA-1975-N-0012-0816 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.2 Protocol Deviations Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:39:45Z   0 0 0900006484718732
FDA-1975-N-0012-0819 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.6.1: Hand Wash and Packaging Weights Details Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:40:29Z   0 0 0900006484718935
FDA-1975-N-0012-0826 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.12: Comments Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:04:17Z   0 0 0900006484718a12
FDA-1975-N-0012-0817 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.4.1: Demographics and Baseline Characteristics Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:39:55Z   0 0 0900006484718733
FDA-1975-N-0012-0828 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Figure 14.2.2.1: Individual Subject Plasma Levels, Linear for C12 and C14 homologs, PK Population Subject Number: 0001 at Day 1 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:15:19Z   0 0 0900006484718b63
FDA-1975-N-0012-0823 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.9: Physical Examination Results - Abnormal Findings Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:59:00Z   0 0 090000648471893e
FDA-1975-N-0012-0821 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Data Listing 16.2.7.1: Adverse Events Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:58:43Z   0 0 090000648471893c
FDA-1975-N-0012-0815 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.1 Subject Disposition and Population Inclusion All Enrolled Subjects (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:39:36Z   0 0 0900006484718731
FDA-1975-N-0012-0810 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. A Pilot Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) After Exaggerated Use of the Antimicrobial Soap on Intact Skin in Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T18:59:17Z   0 0 0900006484717942
FDA-1975-N-0012-0813 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Curriculum Vitaes re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T18:59:58Z   0 0 0900006484717945
FDA-1975-N-0012-0809 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Study No_TKL MC000520 CSP Final A Pivotal Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin in Healthy Volunteers Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T18:59:02Z   0 0 090000648471742e
FDA-1975-N-0012-0811 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Case Report Form Booklet Final Version # 1.0 November 04, 2019 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T18:59:35Z   0 0 0900006484717943
FDA-1975-N-0012-0820 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Statistical Analysis Plan re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:58:33Z   0 0 090000648471849a
FDA-1975-N-0012-0822 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.8: Vital Signs Test Results Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:58:52Z   0 0 090000648471893d
FDA-1975-N-0012-0824 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.10.1: Laboratory Test Results, Chemistry, Part 1 Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:59:09Z   0 0 0900006484718a0f
FDA-1975-N-0012-0814 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Signatures of Authors, Principal Investigator, and Sponsor's Medical Officer re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:17:24Z   0 0 09000064847183f5
FDA-1975-N-0012-0818 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.5.1: Plasma Concentration (ng/L) - C12 homologs Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use SORRY Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T19:40:18Z   0 0 0900006484718734
FDA-1975-N-0012-0825 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Inc. Listing 16.2.11: Childbearing Potential and Urine Pregnancy Test Results All Female Subjects (N= 20) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T20:01:41Z   0 0 0900006484718a11
FDA-1975-N-0012-0788 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-2-coas-of-reference-standards Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:03:08Z   0 0 090000648470d126
FDA-1975-N-0012-0787 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-1-preparation-acceptance-criteria-for-cc-qc-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:01:40Z   0 0 090000648470d125
FDA-1975-N-0012-0797 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-6-3-ba-3rd-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:17:07Z   0 0 090000648470d515
FDA-1975-N-0012-0785 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Appendix 2_BAC IVDP Foaming Liquid Handwashes 06.2020 CRL FINAL Report Supporting & Related Material Background Material 2020-06-25T04:00:00Z 2020 6     2020-06-25T17:09:01Z   0 0 090000648470c91d
FDA-1975-N-0012-0807 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-2-coas-of-reference-standards Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:41:14Z   0 0 090000648470d834
FDA-1975-N-0012-0800 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-6-2-ba-2nd-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:40:02Z   0 0 090000648470d80c
FDA-1975-N-0012-0799 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-6-ba-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:39:52Z   0 0 090000648470d5e5
FDA-1975-N-0012-0796 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-6-2-ba-2nd-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:15:53Z   0 0 090000648470d0ff
FDA-1975-N-0012-0808 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-1-preparation-acceptance-criteria-for-cc-qc-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:41:23Z   0 0 090000648470d836
FDA-1975-N-0012-0802 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-bioanalyt-pmut-052019 Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:40:28Z   0 0 090000648470d810
FDA-1975-N-0012-0803 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-6-incurred-samples-reanalysis-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:40:37Z   0 0 090000648470d812
FDA-1975-N-0012-0790 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-4-representative-chromatograms Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:07:11Z   0 0 090000648470d128
FDA-1975-N-0012-0805 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-4-result-tables-of-all-runs Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:40:57Z   0 0 090000648470d830
FDA-1975-N-0012-0786 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Appendix 3_lonza_pmut_052019_csr Supporting & Related Material Background Material 2020-06-25T04:00:00Z 2020 6     2020-06-25T17:10:56Z   0 0 090000648470c964
FDA-1975-N-0012-0784 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Appendix 1_Lonza FINAL July 3_2019 Prelim Meeting Preliminary Commt for July 2019 MTG Supporting & Related Material Background Material 2020-06-25T04:00:00Z 2020 6     2020-06-25T17:09:14Z   0 0 090000648470c91c
FDA-1975-N-0012-0793 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-7-incurred-samples-reanalysis-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:11:20Z   0 0 090000648470d174
FDA-1975-N-0012-0791 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-5-result-tables-of-all-runs Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:08:19Z   0 0 090000648470d129
FDA-1975-N-0012-0782 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Briefing Document BAC June 2020_Final Other Memo 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T17:00:38Z   0 0 090000648470c914
FDA-1975-N-0012-0806 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-3-representative-chromatograms Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:41:06Z   0 0 090000648470d832
FDA-1975-N-0012-0789 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-3-multianalyte-reanalysis-batches-data Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:04:41Z   0 0 090000648470d127
FDA-1975-N-0012-0804 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-5-Criteria-for-sample-reanalysis-and-reporting-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:40:46Z   0 0 090000648470d814
FDA-1975-N-0012-0783 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza Study No_TKL MC000520 CSP Final v1.0 19June2020 - signed Other Studies 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T17:01:52Z   0 0 090000648470c915
FDA-1975-N-0012-0792 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-6-Criteria-for-sample-reanalysis-and-reporting-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:10:02Z   0 0 090000648470d0db
FDA-1975-N-0012-0801 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-6-1-ba-1st-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:40:18Z   0 0 090000648470d80e
FDA-1975-N-0012-0794 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-5-bioanalyt-pmut-052019 Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:12:35Z   0 0 090000648470d175
FDA-1975-N-0012-0798 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-6-ba-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:18:17Z   0 0 090000648470d516
FDA-1975-N-0012-0795 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 16-6-1-ba-1st-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:14:43Z   0 0 090000648470d0fe
FDA-1975-N-0012-0781 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 MONOGRAPH Meeting Granted Letter Lonza and Henkel 2020 Benzalkonium Hand Soaps Other Request 2020-06-24T04:00:00Z 2020 6 2020-06-24T04:00:00Z   2020-06-24T13:01:00Z   0 0 0900006484704aa9

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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);