Dossier DOS-023

Dossier in NeeS format, version 1.0.6, for application PMDA-2022-0023. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-023
Format
NeeS
Version
1.0.6
Status
Completed
Application
PMDA-2022-0023
Created
2022-03-15
Updated
2024-04-19
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information13Failed
2CTD Summaries4Submitted
3Quality12Active
4Nonclinical Study Reports8Draft
5Clinical Study Reports9Approved
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0232.9.4Nonclinical Summary7.0XML12,196ActiveLieselotte van der Berg
CC-1233.5.8Drug Substance5.9HTML8,835OverdueCarlos Mendez
CC-2232.6.6Nonclinical Overview9.3XML7,169ActiveTomoko Ikeda
CC-3233.3.3Analytical Methods12.4PDF1,618ActiveTomoko Ikeda
CC-4233.1.1Analytical Methods4.5XML7,330ActiveNadia Petrova
CC-5235.7.2Study Reports – Clinical Pharmacology5.7PDF5,361FailedPriya Sharma
CC-6235.7.5Study Reports – Safety4.5HTML637PendingDmitri Volkov
CC-7231.5.3Proposed Conditions of Approval5.6XML14,373BlockedLieselotte van der Berg
CC-8233.5.6Analytical Methods1.5HTML13,483OverdueTomoko Ikeda
CC-9231.7.7Proposed Conditions of Approval2.4Word7,571FailedCarlos Mendez
CC-10232.3.3Quality Overall Summary3.9PDF837FailedPriya Sharma
CC-11234.8.7Toxicology Studies5.4Word11,689DraftPriya Sharma
CC-12232.1.2Clinical Overview6.2XML4,708In ProgressTomoko Ikeda
CC-13231.8.6Cover Letter8.8HTML14,483FailedDmitri Volkov
CC-14232.3.9Clinical Overview10.8Word5,521In ProgressLieselotte van der Berg
CC-15232.7.1Clinical Overview7.8PDF14,649DraftLieselotte van der Berg
CC-16233.9.7Container Closure System3.5Word1,805DraftLieselotte van der Berg
CC-17231.7.4Patient Labeling10.1HTML4,024OverdueMarcus Webb
CC-18234.8.8Genotoxicity2.2HTML5,836DraftSarah Chen
CC-19233.8.9Manufacturing Process2.0PDF13,669DraftMarcus Webb