Dossier DOS-036

Dossier in CTD format, version 5.0.3, for application TITCK-2024-0036. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-036
Format
CTD
Version
5.0.3
Status
Blocked
Application
TITCK-2024-0036
Created
2022-11-16
Updated
2024-02-09
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information7Draft
2CTD Summaries9Pending
3Quality14Completed
4Nonclinical Study Reports7Submitted
5Clinical Study Reports15Overdue
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0364.3.4Toxicology Studies7.8PDF6,392BlockedAisha Okonkwo
CC-1364.1.7Carcinogenicity7.5HTML12,674ApprovedNadia Petrova
CC-2363.3.6Manufacturing Process7.2PDF10,686CompletedSarah Chen
CC-3364.5.6Pharmacology Studies8.3HTML4,929In ProgressJames O'Brien
CC-4364.4.1Toxicology Studies9.8PDF5,739DraftNadia Petrova
CC-5365.5.9Study Reports – Safety11.6Word13,397BlockedAisha Okonkwo
CC-6362.4.9Clinical Overview9.4Word9,208ActivePriya Sharma
CC-7364.5.8Genotoxicity7.1Word12,771BlockedSarah Chen
CC-8362.7.9Clinical Overview11.6HTML7,159PendingDmitri Volkov
CC-9364.5.9Genotoxicity5.9Word8,390PendingAisha Okonkwo
CC-10363.5.8Manufacturing Process8.9Word10,477CompletedLieselotte van der Berg
CC-11364.8.6Pharmacology Studies8.8XML3,665FailedCarlos Mendez
CC-12362.6.4Nonclinical Overview6.9HTML688CompletedNadia Petrova
CC-13365.7.1Study Reports – Efficacy1.5HTML11,739DraftNadia Petrova
CC-14362.3.9Clinical Overview10.9Word14,235OverdueJames O'Brien
CC-15363.8.1Analytical Methods2.6HTML13,510ApprovedNadia Petrova
CC-16364.1.2Pharmacokinetics Studies6.8HTML9,341FailedPriya Sharma
CC-17362.8.2Quality Overall Summary9.8Word578DraftAisha Okonkwo
CC-18365.1.5Study Reports – Clinical Pharmacology5.8PDF14,138PendingLieselotte van der Berg
CC-19361.7.7Patient Labeling4.5HTML4,407OverdueAisha Okonkwo