Dossier DOS-080

Dossier in eCTD format, version 1.5.6, for application MOH-IL-2020-0080. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-080
Format
eCTD
Version
1.5.6
Status
Submitted
Application
MOH-IL-2020-0080
Created
2022-10-16
Updated
2024-05-24
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information6Draft
2CTD Summaries4Blocked
3Quality7Pending
4Nonclinical Study Reports7Active
5Clinical Study Reports4Pending
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0802.9.1Quality Overall Summary2.1HTML12,128BlockedCarlos Mendez
CC-1803.9.6Drug Product9.2PDF5,352DraftNadia Petrova
CC-2803.5.3Container Closure System7.2XML7,359OverdueMarcus Webb
CC-3802.6.8Quality Overall Summary4.4HTML11,267FailedTomoko Ikeda
CC-4801.4.9Cover Letter4.5Word7,931ApprovedLieselotte van der Berg
CC-5802.7.4Quality Overall Summary9.6Word4,188In ProgressMarcus Webb
CC-6803.1.3Drug Substance9.3Word9,893SubmittedPriya Sharma
CC-7805.2.6Integrated Summary of Safety10.3XML12,024ApprovedMarcus Webb
CC-8802.7.4Nonclinical Summary11.5Word10,843PendingSarah Chen
CC-9805.1.1Integrated Summary of Safety9.1PDF3,862ApprovedCarlos Mendez
CC-10805.5.9Study Reports – Clinical Pharmacology2.5XML7,596FailedSarah Chen
CC-11802.4.2Clinical Overview10.0Word12,658In ProgressCarlos Mendez
CC-12805.4.5Study Reports – Efficacy7.4HTML11,869DraftNadia Petrova
CC-13804.7.2Carcinogenicity4.3PDF12,477DraftPriya Sharma
CC-14802.1.7Clinical Overview5.5Word14,490FailedCarlos Mendez
CC-15804.6.9Carcinogenicity8.8PDF6,011PendingSarah Chen
CC-16802.4.8Quality Overall Summary5.9HTML9,825ActiveCarlos Mendez
CC-17805.9.1Study Reports – Safety6.5Word6,101CompletedPriya Sharma
CC-18805.1.6Study Reports – Safety11.5PDF1,476OverdueLieselotte van der Berg
CC-19805.7.4Study Reports – Clinical Pharmacology10.1Word7,777OverdueJames O'Brien