Dossier DOS-043

Dossier in eCTD format, version 8.8.0, for application PMDA-2022-0043. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-043
Format
eCTD
Version
8.8.0
Status
Failed
Application
PMDA-2022-0043
Created
2022-09-29
Updated
2023-08-16
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information9Failed
2CTD Summaries4Blocked
3Quality15In Progress
4Nonclinical Study Reports3Blocked
5Clinical Study Reports6Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0432.1.9Clinical Summary5.1XML2,866DraftAisha Okonkwo
CC-1435.3.3Integrated Summary of Efficacy10.0XML6,182PendingAisha Okonkwo
CC-2431.6.8Prescribing Information2.1Word5,779BlockedTomoko Ikeda
CC-3433.2.4Analytical Methods8.6XML11,060In ProgressCarlos Mendez
CC-4435.5.9Integrated Summary of Efficacy2.6PDF11,419FailedCarlos Mendez
CC-5431.4.3Proposed Conditions of Approval5.9HTML8,805FailedMarcus Webb
CC-6433.5.4Appendices7.8Word11,752DraftDmitri Volkov
CC-7431.6.7Patient Labeling6.2Word11,272FailedAisha Okonkwo
CC-8434.7.3Toxicology Studies9.3Word8,513PendingCarlos Mendez
CC-9431.8.7Patient Labeling12.6HTML10,459ApprovedLieselotte van der Berg
CC-10433.9.1Stability Data9.9HTML13,130BlockedPriya Sharma
CC-11433.9.2Container Closure System6.8PDF7,896ActiveNadia Petrova
CC-12434.6.9Genotoxicity12.3XML6,649OverdueJames O'Brien
CC-13433.6.6Appendices9.3Word6,546ApprovedMarcus Webb
CC-14432.5.8Nonclinical Summary2.6HTML4,862PendingLieselotte van der Berg
CC-15434.9.7Genotoxicity2.5PDF13,961CompletedNadia Petrova
CC-16435.9.6Integrated Summary of Efficacy7.8Word4,747FailedSarah Chen
CC-17435.6.9Study Reports – Efficacy10.5Word8,690In ProgressDmitri Volkov
CC-18433.5.6Stability Data7.6XML9,661In ProgressPriya Sharma
CC-19434.9.8Pharmacokinetics Studies8.7PDF10,258ApprovedAisha Okonkwo