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withdrawn,object_id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