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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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