Dossier DOS-076

Dossier in eCTD format, version 5.1.7, for application TITCK-2024-0076. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-076
Format
eCTD
Version
5.1.7
Status
Blocked
Application
TITCK-2024-0076
Created
2022-07-20
Updated
2024-05-01
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information7Active
2CTD Summaries5Submitted
3Quality14Draft
4Nonclinical Study Reports8Completed
5Clinical Study Reports9Completed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0763.8.9Stability Data1.3HTML13,302In ProgressMarcus Webb
CC-1763.4.8Analytical Methods3.6PDF4,839OverdueNadia Petrova
CC-2761.9.5Proposed Conditions of Approval12.2XML8,470SubmittedCarlos Mendez
CC-3761.5.3Proposed Conditions of Approval8.9PDF8,455FailedCarlos Mendez
CC-4765.2.5Integrated Summary of Safety11.4PDF10,823DraftDmitri Volkov
CC-5763.6.2Drug Product11.4Word10,419SubmittedSarah Chen
CC-6761.1.5Cover Letter11.2HTML10,693BlockedPriya Sharma
CC-7762.9.3Clinical Summary2.6XML12,445SubmittedMarcus Webb
CC-8763.8.9Stability Data3.3Word6,102CompletedCarlos Mendez
CC-9763.3.2Container Closure System10.8PDF9,263ActiveAisha Okonkwo
CC-10763.9.6Drug Substance11.5HTML10,465FailedMarcus Webb
CC-11762.8.7Clinical Overview7.9HTML8,610ActiveTomoko Ikeda
CC-12762.4.4Clinical Summary1.1XML11,337ApprovedPriya Sharma
CC-13764.2.8Pharmacokinetics Studies11.2XML636DraftCarlos Mendez
CC-14765.5.7Integrated Summary of Efficacy12.3HTML13,383In ProgressJames O'Brien
CC-15765.2.4Integrated Summary of Safety5.5PDF10,163DraftLieselotte van der Berg
CC-16762.1.2Nonclinical Overview12.7Word11,378ApprovedLieselotte van der Berg
CC-17761.5.9Application Form6.4XML14,535ActivePriya Sharma
CC-18763.5.3Drug Substance7.5XML1,022OverdueAisha Okonkwo
CC-19764.7.3Toxicology Studies7.3HTML8,716CompletedPriya Sharma