Dossier DOS-091

Dossier in CTD format, version 6.9.2, for application TFDA-2024-0091. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-091
Format
CTD
Version
6.9.2
Status
Failed
Application
TFDA-2024-0091
Created
2022-12-24
Updated
2023-07-10
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information14In Progress
2CTD Summaries6Failed
3Quality5Approved
4Nonclinical Study Reports4Submitted
5Clinical Study Reports11Approved
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0914.5.1Pharmacology Studies11.6PDF11,112OverdueSarah Chen
CC-1912.1.1Nonclinical Summary9.6HTML5,976SubmittedLieselotte van der Berg
CC-2914.6.6Pharmacokinetics Studies1.9XML1,096BlockedCarlos Mendez
CC-3912.1.9Nonclinical Summary6.7XML8,109BlockedCarlos Mendez
CC-4912.8.6Nonclinical Overview7.5PDF13,636BlockedAisha Okonkwo
CC-5913.9.9Container Closure System7.9Word12,419ActiveTomoko Ikeda
CC-6915.3.9Study Reports – Efficacy2.6HTML14,108OverdueNadia Petrova
CC-7912.9.4Clinical Summary12.1PDF6,985OverduePriya Sharma
CC-8912.1.8Clinical Overview1.5PDF13,210DraftDmitri Volkov
CC-9913.4.8Drug Product5.5Word7,070In ProgressNadia Petrova
CC-10913.5.7Drug Substance9.5XML4,614FailedPriya Sharma
CC-11913.1.8Appendices6.3PDF4,707In ProgressLieselotte van der Berg
CC-12912.5.4Nonclinical Overview6.3HTML11,425ActiveCarlos Mendez
CC-13913.2.5Drug Substance3.4HTML10,258ActiveTomoko Ikeda
CC-14915.2.8Integrated Summary of Efficacy8.2XML3,920SubmittedTomoko Ikeda
CC-15913.5.1Appendices6.9PDF2,248BlockedAisha Okonkwo
CC-16915.3.2Integrated Summary of Efficacy6.4HTML3,071In ProgressDmitri Volkov
CC-17914.8.5Carcinogenicity5.4XML12,063In ProgressAisha Okonkwo
CC-18914.4.6Pharmacokinetics Studies4.4XML9,156ActiveLieselotte van der Berg
CC-19912.7.8Clinical Overview6.2PDF4,754ApprovedAisha Okonkwo