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57 rows where docket_id = "FDA-2016-N-0124" and posted_year = 2020 sorted by posted_date descending

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document_type 3

  • Other 32
  • Supporting & Related Material 24
  • Notice 1

posted_year 1

  • 2020 · 57 ✖

agency_id 1

  • FDA 57
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-N-0124-0410 FDA None FDA-2016-N-0124 Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability Notice Notice of Availability 2020-12-31T05:00:00Z 2020 12 2020-12-31T05:00:00Z   2020-12-31T14:14:51Z 2020-28929 0 0 09000064849d654d
FDA-2016-N-0124-0411 FDA None FDA-2016-N-0124 Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability Other Guidance 2020-12-31T05:00:00Z 2020 12 2020-12-31T05:00:00Z   2024-11-12T23:26:51Z   1 0 09000064849d6159
FDA-2016-N-0124-0409 FDA None FDA-2016-N-0124 The American CIeaning Institute Progress Report Other Report 2020-12-04T05:00:00Z 2020 12 2020-12-04T05:00:00Z   2020-12-04T16:13:10Z   0 0 0900006484986dd5
FDA-2016-N-0124-0408 FDA None FDA-2016-N-0124 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   2020-11-23T13:08:25Z   0 0 0900006484970496
FDA-2016-N-0124-0407 FDA None FDA-2016-N-0124 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   2020-11-20T14:38:40Z   0 0 090000648496ca62
FDA-2016-N-0124-0406 FDA None FDA-2016-N-0124 ACI Advice November 18 2020 Other Letter(s) 2020-11-20T05:00:00Z 2020 11 2020-11-20T05:00:00Z   2020-11-20T14:34:16Z   0 0 090000648496ca5c
FDA-2016-N-0124-0405 FDA None FDA-2016-N-0124 ACI BZT Monograph Meeting Minutes Written Responses Supporting & Related Material Meeting Materials 2020-10-06T04:00:00Z 2020 10     2020-10-06T14:59:41Z   0 0 09000064848de180
FDA-2016-N-0124-0404 FDA None FDA-2016-N-0124 Meeting Minutes for Lonza & Henkel’s benzalkonium chloride consumer antiseptic hand wash July 30 2020 Other Minutes 2020-08-26T04:00:00Z 2020 8 2020-08-26T04:00:00Z   2020-08-26T13:56:29Z   0 0 09000064848202dd
FDA-2016-N-0124-0395 FDA None FDA-2016-N-0124 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     2020-06-29T21:09:31Z   0 0 0900006484719149
FDA-2016-N-0124-0389 FDA None FDA-2016-N-0124 Lonza, Inc. and Henkel Corporation, 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     2020-06-29T20:51:09Z   0 0 0900006484719143
FDA-2016-N-0124-0403 FDA None FDA-2016-N-0124 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     2020-06-29T21:27:08Z   0 0 0900006484719220
FDA-2016-N-0124-0393 FDA None FDA-2016-N-0124 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 Supporting & Related Material Background Material 2020-06-29T04:00:00Z 2020 6     2020-06-29T21:04:49Z   0 0 0900006484719147
FDA-2016-N-0124-0386 FDA None FDA-2016-N-0124 Henkel Corporation, Inc. 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     2020-06-29T20:42:31Z   0 0 0900006484719140
FDA-2016-N-0124-0390 FDA None FDA-2016-N-0124 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     2020-06-29T20:59:15Z   0 0 0900006484719144
FDA-2016-N-0124-0399 FDA None FDA-2016-N-0124 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     2020-06-29T21:17:26Z   0 0 090000648471921c
FDA-2016-N-0124-0402 FDA None FDA-2016-N-0124 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     2020-06-29T21:25:07Z   0 0 090000648471921f
FDA-2016-N-0124-0400 FDA None FDA-2016-N-0124 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     2020-06-29T21:19:32Z   0 0 090000648471921d
FDA-2016-N-0124-0387 FDA None FDA-2016-N-0124 Lonza Inc. INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY 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     2020-06-29T20:45:15Z   0 0 0900006484719141
FDA-2016-N-0124-0385 FDA None FDA-2016-N-0124 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     2020-06-29T20:42:03Z   0 0 0900006484718cdb
FDA-2016-N-0124-0391 FDA None FDA-2016-N-0124 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     2020-06-29T21:01:01Z   0 0 0900006484719145
FDA-2016-N-0124-0396 FDA None FDA-2016-N-0124 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     2020-06-29T21:11:56Z   0 0 0900006484719219
FDA-2016-N-0124-0398 FDA None FDA-2016-N-0124 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     2020-06-29T21:15:35Z   0 0 090000648471921b
FDA-2016-N-0124-0397 FDA None FDA-2016-N-0124 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     2020-06-29T21:13:50Z   0 0 090000648471921a
FDA-2016-N-0124-0401 FDA None FDA-2016-N-0124 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     2020-06-29T21:23:13Z   0 0 090000648471921e
FDA-2016-N-0124-0394 FDA None FDA-2016-N-0124 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     2020-06-29T21:07:10Z   0 0 0900006484719148
FDA-2016-N-0124-0384 FDA None FDA-2016-N-0124 Lonza Inc. 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 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     2020-06-29T20:42:18Z   0 0 0900006484718cd5
FDA-2016-N-0124-0392 FDA None FDA-2016-N-0124 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     2020-06-29T21:02:58Z   0 0 0900006484719146
FDA-2016-N-0124-0388 FDA None FDA-2016-N-0124 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     2020-06-29T20:48:34Z   0 0 0900006484719142
FDA-2016-N-0124-0370 FDA None FDA-2016-N-0124 16-5-4-representative-chromatograms Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:34Z   0 0 090000648470d5dd
FDA-2016-N-0124-0383 FDA None FDA-2016-N-0124 16-6-ba-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:37:09Z   0 0 090000648470d617
FDA-2016-N-0124-0375 FDA None FDA-2016-N-0124 16-5-2-coas-of-reference-standards Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:30:08Z   0 0 090000648470d52b
FDA-2016-N-0124-0361 FDA None FDA-2016-N-0124 Appendix 3_lonza_pmut_052019_csr Supporting & Related Material Background Material 2020-06-25T04:00:00Z 2020 6     2020-06-25T17:15:28Z   0 0 090000648470bb28
FDA-2016-N-0124-0367 FDA None FDA-2016-N-0124 16-5-7-incurred-samples-reanalysis-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:05Z   0 0 090000648470d5d1
FDA-2016-N-0124-0376 FDA None FDA-2016-N-0124 16-5-3-representative-chromatograms Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:31:05Z   0 0 090000648470d52c
FDA-2016-N-0124-0369 FDA None FDA-2016-N-0124 16-5-5-result-tables-of-all-runs Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:24Z   0 0 090000648470d5d5
FDA-2016-N-0124-0359 FDA None FDA-2016-N-0124 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     2020-06-25T17:15:13Z   0 0 090000648470bb2a
FDA-2016-N-0124-0378 FDA None FDA-2016-N-0124 16-5-5-Criteria-for-sample-reanalysis-and-reporting-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:32:46Z   0 0 090000648470d2b0
FDA-2016-N-0124-0362 FDA None FDA-2016-N-0124 16-6-ba-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:06Z   0 0 090000648470d1e6
FDA-2016-N-0124-0379 FDA None FDA-2016-N-0124 16-5-6-incurred-samples-reanalysis-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:33:33Z   0 0 090000648470d2b6
FDA-2016-N-0124-0371 FDA None FDA-2016-N-0124 16-5-3-multianalyte-reanalysis-batches-data Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:43Z   0 0 090000648470d5df
FDA-2016-N-0124-0372 FDA None FDA-2016-N-0124 16-5-2-coas-of-reference-standards Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:54Z   0 0 090000648470d5e1
FDA-2016-N-0124-0364 FDA None FDA-2016-N-0124 16-6-2-ba-2nd-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:26Z   0 0 090000648470d1ea
FDA-2016-N-0124-0374 FDA None FDA-2016-N-0124 16-5-1-preparation-acceptance-criteria-for-cc-qc-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:29:21Z   0 0 090000648470d52a
FDA-2016-N-0124-0357 FDA None FDA-2016-N-0124 Briefing Document BAC June 2020_Final Other Memo 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T17:12:57Z   0 0 090000648470c918
FDA-2016-N-0124-0368 FDA None FDA-2016-N-0124 16-5-6-Criteria-for-sample-reanalysis-and-reporting-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:22:15Z   0 0 090000648470d5d3
FDA-2016-N-0124-0381 FDA None FDA-2016-N-0124 16-6-1-ba-1st-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:35:16Z   0 0 090000648470d2b8
FDA-2016-N-0124-0373 FDA None FDA-2016-N-0124 16-5-1-preparation-acceptance-criteria-for-cc-qc-sop Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:23:04Z   0 0 090000648470d5e3
FDA-2016-N-0124-0358 FDA None FDA-2016-N-0124 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   2020-06-25T17:13:28Z   0 0 090000648470c91a
FDA-2016-N-0124-0360 FDA None FDA-2016-N-0124 Appendix 2_BAC IVDP Foaming Liquid Handwashes 06.2020 CRL FINAL Report Supporting & Related Material Background Material 2020-06-25T04:00:00Z 2020 6     2020-06-25T17:15:20Z   0 0 090000648470bb29
FDA-2016-N-0124-0377 FDA None FDA-2016-N-0124 16-5-4-result-tables-of-all-runs Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:32:00Z   0 0 090000648470d52d
FDA-2016-N-0124-0365 FDA None FDA-2016-N-0124 16-6-1-ba-1st-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:36Z   0 0 090000648470d5cd
FDA-2016-N-0124-0380 FDA None FDA-2016-N-0124 16-5-bioanalyt-pmut-052019 Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:34:23Z   0 0 090000648470d2b7
FDA-2016-N-0124-0363 FDA None FDA-2016-N-0124 16-6-3-ba-3rd-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:15Z   0 0 090000648470d1e8
FDA-2016-N-0124-0382 FDA None FDA-2016-N-0124 16-6-2-ba-2nd-add-to-validationreport Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:36:15Z   0 0 090000648470d2b9
FDA-2016-N-0124-0366 FDA None FDA-2016-N-0124 16-5-bioanalyt-pmut-052019 Other Report 2020-06-25T04:00:00Z 2020 6 2020-06-25T04:00:00Z   2020-06-25T19:21:55Z   0 0 090000648470d5cf
FDA-2016-N-0124-0356 FDA None FDA-2016-N-0124 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   2020-06-24T13:02:40Z   0 0 0900006484704aad
FDA-2016-N-0124-0354 FDA None FDA-2016-N-0124 Request for Type C Meeting from Lewis and Harrison to FDA CDER/DNDP/ ODE IV Other Request 2020-03-13T04:00:00Z 2020 3 2020-03-13T04:00:00Z   2020-03-13T20:20:10Z   0 0 0900006484443e02

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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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