Dossier DOS-027

Dossier in CTD format, version 8.0.6, for application TGA-2023-0027. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-027
Format
CTD
Version
8.0.6
Status
Blocked
Application
TGA-2023-0027
Created
2022-03-21
Updated
2023-02-28
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information4Draft
2CTD Summaries3Overdue
3Quality6Draft
4Nonclinical Study Reports15Blocked
5Clinical Study Reports10Completed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0272.7.5Nonclinical Summary11.8Word8,132In ProgressJames O'Brien
CC-1274.1.1Pharmacology Studies10.8Word13,305OverdueLieselotte van der Berg
CC-2273.9.9Container Closure System9.1XML1,749FailedPriya Sharma
CC-3272.4.3Clinical Summary12.9Word3,067In ProgressTomoko Ikeda
CC-4275.2.4Integrated Summary of Efficacy5.7Word622CompletedLieselotte van der Berg
CC-5275.6.1Study Reports – Safety5.1HTML744CompletedSarah Chen
CC-6272.2.1Nonclinical Overview6.8Word5,770DraftTomoko Ikeda
CC-7273.7.8Container Closure System7.7HTML7,482PendingDmitri Volkov
CC-8271.4.9Prescribing Information12.3PDF1,198CompletedAisha Okonkwo
CC-9272.8.7Clinical Overview12.0XML2,717SubmittedMarcus Webb
CC-10275.6.3Study Reports – Safety8.8PDF11,416ActiveLieselotte van der Berg
CC-11271.4.8Application Form1.1Word7,237FailedAisha Okonkwo
CC-12272.2.4Clinical Summary8.4Word8,099ActiveLieselotte van der Berg
CC-13275.2.9Integrated Summary of Efficacy4.6PDF4,283BlockedMarcus Webb
CC-14274.2.1Carcinogenicity1.6XML12,408FailedNadia Petrova
CC-15272.1.9Nonclinical Summary8.8PDF4,278In ProgressDmitri Volkov
CC-16274.5.1Carcinogenicity6.2PDF6,637FailedPriya Sharma
CC-17271.6.2Prescribing Information7.0Word3,251OverdueNadia Petrova
CC-18271.2.9Patient Labeling9.8HTML13,452DraftLieselotte van der Berg
CC-19275.5.6Integrated Summary of Safety4.8HTML2,506In ProgressDmitri Volkov