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125742_S1_M4_4.2.3.2 38166.pdfMarch 1, 202321 MB
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pd production 030123.zipMarch 1, 202345 MB
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125742_S1_M2_2.6.3.1 pharmacol tabulated summaryFebruary 1, 20232 MB
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125742_S68_M1_lab-1448-0-6-pkg-insert-clean.pdfJanuary 3, 20231 MB
125742_S68_M1_lab-1448-0-6-annotated.pdfJanuary 3, 20233 MB
125742_S64_M1_sticker-comdilrm.pdfJanuary 3, 2023180 KB
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125742_S64_M1_carton-com195lkz-kzoo.pdfJanuary 3, 2023135 KB
125742_S64_M1_carton-com25ctpus-puursJanuary 3, 2023242 KB
125742_S64_M1_carton-com25ctkz-kzoo.pdfJanuary 3, 2023217 KB
FDA-CBER-2021-5683-0703843-0708840-125742_S1_M5_c4591001-S-Supp-D-suppae.xpt.zipJanuary 3, 2023845 KB
125742_S58_M1_lab-1448-0-5-pkg-insert-track.pdfJanuary 3, 2023879 KB
FDA-CBER-2021-5683-0698920-0703842-125742_S1_M5_c4591001-S-D-suppae.xpt.zipJanuary 3, 2023825 KB
125742_S58_M1_lab-1448-0-5-pkg-insert-clean.pdfJanuary 3, 2023878 KB
FDA-CBER-2021-5683-0688438-0698919-125742_S1_M5_c4591001-S-D-vs.xpt.zipJanuary 3, 20237 MB
125742_S58_M1_lab-1448-0-5-annotated.pdfJanuary 3, 20233 MB
FDA-CBER-2021-5683-0681346-0688437-125742_S1_M5_c4591001-S-D-ds.xpt.zipJanuary 3, 20232 MB
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125742_S54_M1_carton-com195lkz-kzooJanuary 3, 2023135 KB
FDA-CBER-2021-5683-0678268-0681345-125742_S1_M5_c4591001-A-D-adds.xpt.zipJanuary 3, 20237 MB
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125742_S51_M5_5351_c4591001-followup-table.pdfJanuary 3, 2023606 KB
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125742_S51_M1_lab-1448-0-4-pkg-insert-track.pdfJanuary 3, 20231 MB
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125742_S51_M1_lab-1448-0-4-pkg-insert-clean.pdfJanuary 3, 20231 MB
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FDA-CBER-2021-5683-0652981-0654506-125742_S1_M5_bnt162-01-A-D-adlb.xpt.zipJanuary 3, 20233 MB
125742_S46_M1_carton-com195lpus-puurs.pdfJanuary 3, 2023179 KB
FDA-CBER-2021-5683-0652961-0652980-125742_S80_M1_lab-1448-1-0-pkg-insert-clean.docxJanuary 3, 2023515 KB
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125742_S46_M1_carton-com195lkz-kzoo.pdfJanuary 3, 2023140 KB
FDA-CBER-2021-5683-0652920-0652940-125742_S76_M1_lab-1448-0-9-annotated.docxJanuary 3, 2023519 KB
125742_S46_M1_carton-com25ctpus-puurs.pdfJanuary 3, 2023241 KB
FDA-CBER-2021-5683-0652899-0652919-125742_S76_M1_lab-1448-0-9-pkg-insert-track.docxJanuary 3, 2023515 KB
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125742_S46_M1_carton-com25ctkz-kzooJanuary 3, 2023217 KB
FDA-CBER-2021-5683-0652859-0652878-125742_S73_M1_lab-1448-0-8-pkg-insert-track.docxJanuary 3, 2023516 KB
FDA-CBER-2021-5683-0652839-0652858-125742_S73_M1_lab-1448-0-8-annotated.docxJanuary 3, 2023521 KB
125742_S41_M1_c4591001-ve-tables.pdfJanuary 3, 2023695 KB
FDA-CBER-2021-5683-0652819-0652838-125742_S73_M1_lab-1448-0-8-pkg-insert-clean.docxJanuary 3, 2023515 KB
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125742_S39_M1_lab-1448-0-3-pkg-insert-track.pdfJanuary 3, 20235 MB
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125742_S39_M1_lab-1448-0-3-pkg-insert-cleanJanuary 3, 20235 MB
FDA-CBER-2021-5683-0652735-0652755-125742_S68_M1_lab-1448-0-6-pkg-insert-track.docxJanuary 3, 2023515 KB
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125742_S39_M1_lab-1448-0-3-annotated.pdfJanuary 3, 20236 MB
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125742_S39_M1_5351_c4591001-ve-tables.pdfJanuary 3, 2023695 KB
FDA-CBER-2021-5683-0652673-0652692-125742_S58_M1_lab-1448-0-5-pkg-insert-clean.docxJanuary 3, 2023514 KB
125742_S38_M5_c4591001-508-safety-tables.pdfJanuary 3, 2023928 KB
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125742_S33_M5_5351_c4591001-508-efficacy-tables.pdfJanuary 3, 2023821 KB
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125742_S29_M1_lab-1448-0-2-pkg-insert-trackJanuary 3, 20231 MB
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125742_S27_M1_response-29jul2021January 3, 20231 MB
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125742_S21_M1_pvp-track.pdfJanuary 3, 20238 MB
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125742_S16_M1_psp-track.pdfJanuary 3, 2023922 KB
125742_S16_M1_ped-studies-deferral-track-change.pdfJanuary 3, 2023664 KB
125742_S13_M5_5351_c4591001-narrative-1226-12262255January 3, 2023626 KB
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130_BLA _125742-0_09-01-2021_Committee Memo_Labeling.pdfJanuary 3, 2023771 KB
FDA-CBER-2021-5683-0652385-0652413-125742_S29_M1_lab-1448-0-2-pkg-insert-clean.docxJanuary 3, 2023535 KB
126_BLA 125742-0_08-23-2021_Memo_OtherJanuary 3, 2023649 KB
125742_S80_M1_lab-1448-1-0-pkg-insert-clean.pdfJanuary 3, 2023875 KB
114A_2_BLA_125742-0_08-21-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S79_M1_lab-1448-1-0-pkg-insert-clean.pdfJanuary 3, 2023875 KB
106A_2_BLA_125742-0_08-20-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S76_M1_lab-1448-0-9-pkg-insert-track.pdfJanuary 3, 20231 MB
98A_BLA_125742-0_08-19-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S76_M1_lab-1448-0-9-pkg-insert-clean.pdfJanuary 3, 20231 MB
125742_S76_M1_lab-1448-0-9-annotated.pdfJanuary 3, 20231 MB
91A_2_BLA_125742-0_08-18-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S73_M1_lab-1448-0-8-pkg-insert-track.pdfJanuary 3, 20231 MB
82A_BLA_125742-0_08-17-2021_Telecon_Labeling via FAX_eJanuary 3, 20231 MB
78_BLA_125742-0_08-17-2021_Memo_Other.pdfJanuary 3, 2023814 KB
77_BLA_125742-0_08-17-2021_Memo_Lot Release Clearance.pdfJanuary 3, 2023805 KB
72A_BLA_125742-0_08-13-2021_Telecon_Labeling via FAX_e.pdfJanuary 3, 20231 MB
125742_S73_M1_lab-1448-0-8-pkg-insert-clean.pdfJanuary 3, 20231 MB
125742_S73_M1_lab-1448-0-8-annotated.pdfJanuary 3, 20233 MB
36A_BLA_125742-0_07-28-2021_Telecon_Labeling Target ClJanuary 3, 20231 MB
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13_BLA_125742-0_07-02-2021_Committee Memo_APLB.pdfJanuary 3, 2023848 KB
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125742_S1_M5_5351_bnt162 01 interim3 sponsor personnel list.pdfMay 2, 20222 MB
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125742_S1_M5_c4591001 S Supp acrf.pdfMay 2, 20223 MB
125742_S1_M5_c4591001 S csdrg.pdfMay 2, 20221 MB
125742_S1_M5_c4591001 S acrf.pdfMay 2, 20223 MB
125742_S1_M5_bnt162 01 S csdrg.pdfMay 2, 20221 MB
125742_S1_M5_bnt162 01 S acrf.pdfMay 2, 20221 MB
125742_S1_M5_bnt162 01 A adrg.pdfMay 2, 2022891 KB
125742_S1_M5_CRF_c4591001 1006 10061176.pdfMay 2, 20223 MB
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125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdfApril 1, 20221 MB
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125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdfApril 1, 202259 MB
125742_S1_M5_5351_c4591001-fa-interim-randomization.pdfApril 1, 20222 MB
125742_S1_M5_5351_c4591001-fa-interim-publications.pdfApril 1, 202210 MB
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdfApril 1, 20221 MB
125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdfApril 1, 2022677 KB
125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdfApril 1, 20228 MB
125742_S1_M5_5351_c4591001-fa-interim-demographics.pdfApril 1, 202228 MB
125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdfApril 1, 2022869 KB
pd-production-040122.zipApril 1, 2022128 MB
pd-production-032422.zipMarch 24, 20222 MB
125742_S1_M1_priority-review-request.pdfMarch 24, 20222 MB
125742_S1_M1_priority-review-request.pdfMarch 24, 20222 MB
cd-production-031622.zipMarch 17, 2022101 KB
034 – Transcript of Scheduling Conference (December 14, 2021).pdfMarch 17, 2022141 KB
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FDA-CBER-2021-5683-0023930_125742_S1_M5_c4591001-A-report-cci-diabetes-without-comp.xlsxMarch 1, 202210 KB
FDA-CBER-2021-5683-0023928_125742_S1_M5_c4591001-A-report-cci-diabetes-with-comp.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023926_125742_S1_M5_c4591001-A-report-cci-dementia.xlsxMarch 1, 20229 KB
FDA-CBER-2021-5683-0023924_125742_S1_M5_c4591001-A-report-cci-chf.xlsxMarch 1, 202210 KB
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FDA-CBER-2021-5683-0023878_125742_S1_M5_c4591001-A-report-cci-aids-hiv.xlsxMarch 1, 202223 KB
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FDA-CBER-2021-5683-0023540_125742_S1_M5_c4591001-A-comorbidity-categories.xlsxMarch 1, 202219 KB
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