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614 rows where docket_id = "FDA-1975-N-0012" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-0012-0843 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Citizen Petition Denial from CDER to Cosmetic, Toiletry, & Fragrance Association (CTFA) & Soap & Detergent Association (SDA) Other Denial of Petition 2023-01-18T05:00:00Z 2023 1 2023-01-18T05:00:00Z   2023-01-18T20:50:05Z   0 0 09000064855f6800
FDA-1975-N-0012-0842 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response Letter from FDA CDER to Hy-Gene Biomedical Corporation Other Response(s) 2023-01-17T05:00:00Z 2023 1 2023-01-17T05:00:00Z   2023-01-17T14:24:23Z   0 0 09000064855f0a42
FDA-1975-N-0012-0841 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Citizen Petition Denial from FDA CDER to Cosmetic, Toiletry & Fragrance Association (CTFA) and Soap & Detergent Association (SDA) Other Denial of Petition 2023-01-17T05:00:00Z 2023 1 2023-01-17T05:00:00Z   2023-01-17T14:23:14Z   0 0 09000064855efa6e
FDA-1975-N-0012-0840 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response Letter from FDA CDER to Personal Care Products Council and American Cleaning Institute Other Agency Response 2023-01-13T05:00:00Z 2023 1 2023-01-13T05:00:00Z   2023-01-13T19:01:09Z   0 0 09000064855ebb2a
FDA-1975-N-0012-0839 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response Letter from FDA CDER to Century Pharmaceuticals, Inc. Other Agency Response 2023-01-12T05:00:00Z 2023 1 2023-01-12T05:00:00Z   2023-01-12T13:21:49Z   0 0 09000064855e620c
FDA-1975-N-0012-0838 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response Letter from FDA CDER to International Laboratory Technology, Corp. Other Response(s) 2022-12-20T05:00:00Z 2022 12 2022-12-20T05:00:00Z   2022-12-20T19:53:56Z   0 0 09000064855445e7
FDA-1975-N-0012-0837 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response Letter from FDA CDER to Woodward Laboratories, Inc. Other Response(s) 2022-12-20T05:00:00Z 2022 12 2022-12-20T05:00:00Z   2022-12-20T14:47:46Z   0 0 09000064855435ce
FDA-1975-N-0012-0836 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response Letter from FDA CDER to Patton Boggs, LLP. Other Response(s) 2022-12-19T05:00:00Z 2022 12 2022-12-19T05:00:00Z   2022-12-19T20:58:01Z   0 0 0900006485542371
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
FDA-1975-N-0012-0780 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Lonza FINAL July 3_2019 Prelim Meeting Preliminary Comment for July 2019 MTG (002) Other Minutes 2019-09-19T04:00:00Z 2019 9 2019-09-19T04:00:00Z   2019-09-19T18:21:56Z   0 0 0900006483f9ee08
FDA-1975-N-0012-0779 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 FINAL Schirripa - FDA Response to Petition for Reconsideration (signed 9 16 19) Other   2019-09-19T00:00:00Z 2019 9     2019-09-19T18:20:46Z   0 1 0900006483f9f14b
FDA-1975-N-0012-0778 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 FINAL Third Extension Deferral Letter Other Letter(s) 2019-08-15T04:00:00Z 2019 8 2019-08-15T04:00:00Z   2019-08-15T20:01:43Z   0 0 0900006483e573de
FDA-1975-N-0012-0777 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA CDER to American Cleaning Institute Other Letter(s) 2019-07-15T04:00:00Z 2019 7 2019-07-15T04:00:00Z   2019-07-15T18:41:24Z   0 0 0900006483d91df0
FDA-1975-N-0012-0776 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 LONZA Meeting Request for July 9 Cancelled Other Letter(s) 2019-07-09T04:00:00Z 2019 7 2019-07-09T04:00:00Z   2019-07-09T15:53:30Z   0 0 0900006483d6f337
FDA-1975-N-0012-0775 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA CDER to Lewis & Harrison Other Letter(s) 2019-06-12T04:00:00Z 2019 6 2019-06-12T04:00:00Z   2019-09-19T16:20:12Z   0 0 0900006483d09084
FDA-1975-N-0012-0774 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Briefing Document from Lewis and Harrison on behalf of Lonza Inc. and Henkel Consumer Goods, Inc. Other Brief 2019-05-31T04:00:00Z 2019 5 2019-05-31T04:00:00Z   2019-05-31T20:36:07Z   0 0 0900006483cc1e7e
FDA-1975-N-0012-0772 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA CDER to Bayer Corporation Other Letter(s) 2019-04-11T04:00:00Z 2019 4 2019-04-11T04:00:00Z   2019-04-11T16:29:52Z   0 0 0900006483b84dd5
FDA-1975-N-0012-0773 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA CDER to Ciba Specialty Chemicals Corporation Other Letter(s) 2019-04-11T04:00:00Z 2019 4 2019-04-11T04:00:00Z   2019-04-11T16:30:30Z   0 0 0900006483b84dd9
FDA-1975-N-0012-0771 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA CDER to Ciba Specialty Chemicals Corporation Other Letter(s) 2019-04-11T04:00:00Z 2019 4 2019-04-11T04:00:00Z   2019-04-11T16:27:45Z   0 0 0900006483b84b71
FDA-1975-N-0012-0770 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Request for a Type C Meeting from Lewis and Harrison on behalf of Lorenz Inc., and Henkel Corporation Other Request 2019-04-09T04:00:00Z 2019 4 2019-04-09T04:00:00Z   2019-05-23T18:28:23Z   0 0 0900006483b7a6b6
FDA-1975-N-0012-0766 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Report from American Cleaning Institute (ACI) Other Report 2019-03-13T04:00:00Z 2019 3 2019-03-13T04:00:00Z   2019-03-13T16:16:45Z   0 0 0900006483ad7c63
FDA-1975-N-0012-0748 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 ACI FINAL Meeting Minutes from Aug 6, 2018 Other Minutes 2018-08-28T04:00:00Z 2018 8 2018-08-28T04:00:00Z   2018-08-28T12:13:24Z   0 0 0900006483662067
FDA-1975-N-0012-0745 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 ACI ETEC 2018 Meeting Granted Letter Other Agreement 2018-07-25T04:00:00Z 2018 7 2018-07-25T04:00:00Z   2018-07-25T11:44:30Z   0 0 090000648355373a
FDA-1975-N-0012-0742 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Final Validation Reports (Bionanalysis Report) from Lonza Inc., and Henkel Consumer Goods, Inc., (Lewis & Harrison) Other Report 2018-07-06T04:00:00Z 2018 7 2018-07-06T04:00:00Z   2018-07-06T14:17:10Z   0 0 09000064834b5e99
FDA-1975-N-0012-0743 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Supplement from American Cleaning Institute Other Supplement (SUP) 2018-07-06T04:00:00Z 2018 7 2016-09-06T04:00:00Z 2019-04-04T03:59:59Z 2018-07-06T15:24:35Z   0 0 090000648343dddf
FDA-1975-N-0012-0740 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Meeting Granted Letter 05/09/2018 Other Letter(s) 2018-07-06T04:00:00Z 2018 7 2018-07-06T04:00:00Z   2018-07-06T14:16:16Z   0 0 09000064834b59fb
FDA-1975-N-0012-0741 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Briefing Documents from Lonza Inc., and Henkel Consumer Goods, Inc., (Lewis & Harrison) Other Studies 2018-07-06T04:00:00Z 2018 7 2018-07-06T04:00:00Z   2018-07-06T14:16:52Z   0 0 09000064834b5e92
FDA-1975-N-0012-0738 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Memo and Meeting Minutes from FDA CDER to Lewis & Harrison Other Minutes 2018-05-30T04:00:00Z 2018 5 2018-05-30T04:00:00Z   2018-05-30T15:25:48Z   0 0 090000648330ee23
FDA-1975-N-0012-0736 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Report from American Cleaning Institute Other Electronic Regulation from Form 2018-05-02T04:00:00Z 2018 5 2018-05-02T04:00:00Z   2018-05-02T21:04:12Z   0 0 0900006483135698
FDA-1975-N-0012-0735 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Grant of Second Extension April 12_2018 Other Extension of Time 2018-04-16T04:00:00Z 2018 4 2018-04-16T04:00:00Z   2018-04-16T14:58:06Z   0 0 0900006483146f92
FDA-1975-N-0012-0734 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Report from American Cleaning Institute Other Report 2018-04-10T04:00:00Z 2018 4 2018-04-10T04:00:00Z   2018-04-10T20:10:46Z   0 0 0900006483090f60
FDA-1975-N-0012-0733 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA to American Cleaning Institute Other Letter(s) 2017-09-11T04:00:00Z 2017 9 2017-09-11T04:00:00Z   2017-09-11T12:05:12Z   0 0 0900006482b1a92c
FDA-1975-N-0012-0732 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Advice Letter from CDER to American Cleaning Institute Other Letter(s) 2017-04-20T04:00:00Z 2017 4 2017-04-20T04:00:00Z   2017-04-20T12:12:24Z   0 0 0900006482562870
FDA-1975-N-0012-0730 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Regulatory Impact Analysis Other Regulatory Analysis 2017-02-23T05:00:00Z 2017 2 2017-02-23T05:00:00Z   2017-02-23T21:24:22Z   0 0 09000064824d9101
FDA-1975-N-0012-0729 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from American Cleaning Institute et al Other Letter(s) 2017-01-24T05:00:00Z 2017 1 2017-01-24T05:00:00Z   2017-01-24T19:21:31Z   0 0 090000648248fe53
FDA-1975-N-0012-0725 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Request for Extension from American Cleaning Institute Other Request for Extension 2017-01-11T05:00:00Z 2017 1 2017-01-11T05:00:00Z   2017-01-11T17:37:16Z   0 0 090000648197daca
FDA-1975-N-0012-0723 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response Letter from American Cleaning Institute (ACI) Other Letter(s) 2016-12-12T05:00:00Z 2016 12 2016-12-12T05:00:00Z   2016-12-12T21:52:28Z   0 0 09000064823fcc03
FDA-1975-N-0012-0722 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Draft Protocol Study from American Cleaning Institute Supporting & Related Material Background Material 2016-11-25T05:00:00Z 2016 11     2016-11-25T14:19:32Z   0 0 09000064823be604
FDA-1975-N-0012-0710 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 58 Infections and Pseudoinfections Due to Povidone-Iodine Solution Contaminated with Pseudomonas cepacia re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:20Z   0 0 09000064821bfd1d
FDA-1975-N-0012-0652 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 List of References re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:48:25Z   0 0 09000064821bfa64
FDA-1975-N-0012-0657 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 5 Minutes_of_Meeting,_11_14_2008 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:39Z   0 0 09000064821bfaa7
FDA-1975-N-0012-0670 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 18 Involvement of efflux mechanisms in biocide resistance of Campylobacter jejuni and Campylobacter coli re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:40Z   0 0 09000064821bfafe
FDA-1975-N-0012-0683 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 31 Investigation of antibiotic and antibacterial agent cross-resistance in target bacteria from homes of antibacterial product users and nonusers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:36Z   0 0 09000064821bfb07
FDA-1975-N-0012-0690 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 38 Use of antibacterial consumer products containing quaternary ammonium compounds and drug resistance in the community re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:02Z   0 0 09000064821bfb1e
FDA-1975-N-0012-0694 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 42 Cross-resistance to antibiotics of Escherichia coli adapted to benzalkonium chloride or exposed to stress-inducers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:42Z   0 0 09000064821bfb22
FDA-1975-N-0012-0696 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 44 Adaptive resistance to benzalkonium chloride, amikacin and tobramycin: the effect on susceptibility to other antimicrobials re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:32Z   0 0 09000064821bfb24

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