Dossier DOS-100

Dossier in eCTD format, version 4.3.9, for application MOH-IL-2020-0100. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-100
Format
eCTD
Version
4.3.9
Status
Failed
Application
MOH-IL-2020-0100
Created
2022-11-23
Updated
2023-07-29
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information7Draft
2CTD Summaries9Completed
3Quality8Submitted
4Nonclinical Study Reports9Active
5Clinical Study Reports12Overdue
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-1001.1.1Cover Letter6.2XML5,548BlockedTomoko Ikeda
CC-2001.3.1Application Form7.6XML12,537FailedLieselotte van der Berg
CC-3005.2.2Study Reports – Efficacy4.4XML7,130PendingTomoko Ikeda
CC-4005.6.9Integrated Summary of Efficacy3.2Word11,933DraftSarah Chen
CC-5001.2.8Prescribing Information9.1PDF6,687PendingLieselotte van der Berg
CC-6005.7.3Integrated Summary of Safety1.8XML14,958DraftLieselotte van der Berg
CC-7001.1.7Application Form12.9HTML14,537OverduePriya Sharma
CC-8005.8.3Integrated Summary of Safety5.5XML1,291DraftPriya Sharma
CC-9002.7.5Quality Overall Summary4.6XML6,965SubmittedDmitri Volkov
CC-10004.8.2Toxicology Studies10.3PDF3,085SubmittedSarah Chen
CC-11005.2.5Study Reports – Safety4.8PDF2,863CompletedTomoko Ikeda
CC-12002.6.2Clinical Summary5.6PDF2,533PendingMarcus Webb
CC-13001.8.5Proposed Conditions of Approval7.5PDF1,322ApprovedNadia Petrova
CC-14002.5.6Clinical Overview2.4HTML5,835OverdueMarcus Webb
CC-15003.2.8Analytical Methods12.1XML10,555ActiveCarlos Mendez
CC-16001.5.3Prescribing Information11.9Word2,270CompletedCarlos Mendez
CC-17002.3.3Nonclinical Summary6.4XML11,928In ProgressDmitri Volkov
CC-18002.8.5Nonclinical Overview7.6PDF9,771FailedMarcus Webb
CC-19004.2.9Genotoxicity9.0XML13,929ActiveTomoko Ikeda
CC-20001.3.3Cover Letter7.4XML12,586OverdueCarlos Mendez