Dossier DOS-056

Dossier in CTD format, version 6.8.6, for application TITCK-2024-0056. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-056
Format
CTD
Version
6.8.6
Status
Completed
Application
TITCK-2024-0056
Created
2022-04-15
Updated
2023-04-28
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information15Overdue
2CTD Summaries11Completed
3Quality8Draft
4Nonclinical Study Reports14In Progress
5Clinical Study Reports12Draft
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0561.1.4Proposed Conditions of Approval11.0Word3,302ActiveSarah Chen
CC-1561.8.9Application Form5.5Word3,249OverdueAisha Okonkwo
CC-2563.8.9Container Closure System10.5HTML3,456ActiveAisha Okonkwo
CC-3561.8.2Prescribing Information4.3XML5,087CompletedPriya Sharma
CC-4565.4.7Study Reports – Clinical Pharmacology12.9PDF10,420PendingSarah Chen
CC-5561.6.2Patient Labeling1.0PDF4,715DraftPriya Sharma
CC-6562.8.4Clinical Summary10.0HTML1,826CompletedJames O'Brien
CC-7561.3.6Cover Letter7.9PDF12,931SubmittedAisha Okonkwo
CC-8565.2.7Integrated Summary of Efficacy6.0HTML6,544ApprovedAisha Okonkwo
CC-9563.6.9Analytical Methods3.3XML7,484ApprovedJames O'Brien
CC-10564.1.7Carcinogenicity12.5XML7,781PendingTomoko Ikeda
CC-11565.9.7Integrated Summary of Safety2.1Word9,235DraftNadia Petrova
CC-12563.5.4Drug Substance11.4Word8,535ApprovedCarlos Mendez
CC-13561.3.8Cover Letter7.4PDF10,877In ProgressDmitri Volkov
CC-14562.1.3Nonclinical Overview1.3HTML3,665ActivePriya Sharma
CC-15562.6.6Nonclinical Summary10.3PDF4,781In ProgressPriya Sharma
CC-16561.4.2Cover Letter12.1HTML1,296ApprovedSarah Chen
CC-17562.8.1Nonclinical Summary4.0XML1,384In ProgressMarcus Webb
CC-18565.7.3Study Reports – Safety11.5PDF11,041BlockedDmitri Volkov
CC-19565.7.9Study Reports – Safety7.3Word6,240ApprovedLieselotte van der Berg