Dossier DOS-047

Dossier in eCTD format, version 4.2.7, for application TGA-2023-0047. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-047
Format
eCTD
Version
4.2.7
Status
Failed
Application
TGA-2023-0047
Created
2022-05-10
Updated
2023-07-16
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information4Submitted
2CTD Summaries5Approved
3Quality3Overdue
4Nonclinical Study Reports6Failed
5Clinical Study Reports15Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0474.2.7Genotoxicity11.8XML8,831FailedTomoko Ikeda
CC-1471.5.4Prescribing Information6.4XML2,828FailedDmitri Volkov
CC-2475.9.4Study Reports – Clinical Pharmacology7.6Word4,736ActiveTomoko Ikeda
CC-3475.2.4Study Reports – Efficacy6.3Word9,050OverdueDmitri Volkov
CC-4471.9.6Prescribing Information12.0HTML13,145CompletedSarah Chen
CC-5471.9.4Cover Letter12.0XML4,240In ProgressLieselotte van der Berg
CC-6472.2.6Clinical Overview4.9Word4,842OverdueAisha Okonkwo
CC-7473.8.4Analytical Methods4.8HTML5,189ActiveSarah Chen
CC-8474.8.1Genotoxicity5.4XML6,689SubmittedSarah Chen
CC-9471.1.6Cover Letter6.1XML11,252ApprovedCarlos Mendez
CC-10471.2.3Application Form6.7HTML13,237FailedMarcus Webb
CC-11474.3.6Genotoxicity3.6HTML3,382BlockedMarcus Webb
CC-12472.6.7Nonclinical Overview8.1PDF3,144OverdueCarlos Mendez
CC-13473.6.8Analytical Methods2.2XML14,086OverdueLieselotte van der Berg
CC-14471.2.1Cover Letter12.6XML9,793ApprovedSarah Chen
CC-15475.3.8Study Reports – Safety1.3Word4,826FailedNadia Petrova
CC-16472.6.2Clinical Summary2.4HTML14,800ApprovedJames O'Brien
CC-17474.6.2Carcinogenicity5.1Word7,052FailedJames O'Brien
CC-18472.8.7Quality Overall Summary7.5Word7,857In ProgressDmitri Volkov
CC-19474.4.6Pharmacology Studies8.9Word10,457ApprovedNadia Petrova