Dossier DOS-087

Dossier in CTD format, version 6.8.0, for application TGA-2023-0087. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-087
Format
CTD
Version
6.8.0
Status
Pending
Application
TGA-2023-0087
Created
2022-06-17
Updated
2023-10-01
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information12Failed
2CTD Summaries12Blocked
3Quality11Active
4Nonclinical Study Reports10Active
5Clinical Study Reports12Failed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0871.3.9Patient Labeling10.6Word12,558In ProgressJames O'Brien
CC-1875.8.1Study Reports – Clinical Pharmacology1.3XML7,911FailedTomoko Ikeda
CC-2873.1.3Manufacturing Process3.2PDF8,469CompletedLieselotte van der Berg
CC-3873.9.5Appendices10.9HTML11,449PendingTomoko Ikeda
CC-4874.2.4Carcinogenicity9.2PDF8,932CompletedMarcus Webb
CC-5874.7.2Pharmacokinetics Studies10.0Word6,697DraftSarah Chen
CC-6874.9.3Genotoxicity7.2Word9,596BlockedAisha Okonkwo
CC-7875.6.2Study Reports – Safety5.0Word946OverdueSarah Chen
CC-8875.4.1Study Reports – Safety1.6PDF5,591PendingMarcus Webb
CC-9874.8.1Toxicology Studies3.7Word2,388In ProgressTomoko Ikeda
CC-10874.9.1Pharmacology Studies1.0PDF7,371ActiveNadia Petrova
CC-11871.6.7Cover Letter4.0Word12,485OverdueCarlos Mendez
CC-12873.8.7Container Closure System4.7Word9,019SubmittedAisha Okonkwo
CC-13873.8.5Appendices7.1HTML6,136CompletedJames O'Brien
CC-14874.4.5Pharmacology Studies12.6HTML4,798FailedMarcus Webb
CC-15871.4.8Cover Letter9.9PDF8,340CompletedMarcus Webb
CC-16872.8.2Nonclinical Summary12.5HTML615SubmittedAisha Okonkwo
CC-17874.4.5Pharmacology Studies11.0PDF10,906ApprovedJames O'Brien
CC-18872.8.2Clinical Summary5.0Word8,765ActiveDmitri Volkov
CC-19874.7.9Pharmacokinetics Studies8.5XML9,502OverdueLieselotte van der Berg