Dossier DOS-011

Dossier in CTD format, version 6.5.0, for application TFDA-2024-0011. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-011
Format
CTD
Version
6.5.0
Status
Overdue
Application
TFDA-2024-0011
Created
2022-11-16
Updated
2024-03-15
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information7Overdue
2CTD Summaries13Approved
3Quality10Failed
4Nonclinical Study Reports7In Progress
5Clinical Study Reports9Pending
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0114.4.2Toxicology Studies7.6HTML4,654In ProgressTomoko Ikeda
CC-1114.9.4Pharmacokinetics Studies6.6XML10,165In ProgressLieselotte van der Berg
CC-2115.1.1Study Reports – Clinical Pharmacology5.0HTML12,224CompletedJames O'Brien
CC-3111.5.8Cover Letter4.6XML3,575BlockedSarah Chen
CC-4113.9.7Appendices4.3Word11,022SubmittedJames O'Brien
CC-5113.5.8Drug Product10.2Word1,512CompletedJames O'Brien
CC-6111.1.1Prescribing Information7.5XML3,290DraftLieselotte van der Berg
CC-7111.6.5Prescribing Information5.2XML6,671PendingJames O'Brien
CC-8112.6.7Nonclinical Overview4.8XML11,667In ProgressTomoko Ikeda
CC-9114.9.3Pharmacokinetics Studies11.4PDF8,524PendingDmitri Volkov
CC-10112.9.4Nonclinical Overview1.7PDF10,132ApprovedAisha Okonkwo
CC-11113.6.4Stability Data3.6Word6,535ActiveMarcus Webb
CC-12111.8.6Proposed Conditions of Approval2.1HTML6,094BlockedPriya Sharma
CC-13115.4.8Integrated Summary of Efficacy12.9XML5,886FailedMarcus Webb
CC-14114.9.3Pharmacology Studies8.5HTML11,214OverdueJames O'Brien
CC-15115.9.4Integrated Summary of Safety12.3PDF9,872OverdueDmitri Volkov
CC-16111.6.8Patient Labeling8.8HTML13,122PendingCarlos Mendez
CC-17111.1.9Patient Labeling4.6HTML14,363ActiveCarlos Mendez
CC-18114.9.9Carcinogenicity2.1XML6,340OverduePriya Sharma
CC-19111.8.5Prescribing Information10.2PDF4,894PendingPriya Sharma