Dossier DOS-071

Dossier in NeeS format, version 7.1.7, for application TFDA-2024-0071. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-071
Format
NeeS
Version
7.1.7
Status
Active
Application
TFDA-2024-0071
Created
2022-05-14
Updated
2023-06-30
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information14Draft
2CTD Summaries6In Progress
3Quality9Submitted
4Nonclinical Study Reports8Failed
5Clinical Study Reports9Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0711.5.7Proposed Conditions of Approval9.6HTML9,603ActiveDmitri Volkov
CC-1711.3.7Application Form11.5PDF11,870CompletedTomoko Ikeda
CC-2712.5.6Clinical Summary4.1XML10,002FailedNadia Petrova
CC-3714.3.2Pharmacokinetics Studies5.5HTML13,582SubmittedDmitri Volkov
CC-4715.7.5Study Reports – Safety10.4PDF14,803PendingLieselotte van der Berg
CC-5712.7.5Clinical Summary4.2PDF3,636ApprovedNadia Petrova
CC-6715.2.4Integrated Summary of Safety7.1HTML4,377DraftMarcus Webb
CC-7711.5.6Prescribing Information4.4PDF1,711OverdueSarah Chen
CC-8713.1.6Manufacturing Process8.1PDF14,443FailedAisha Okonkwo
CC-9714.2.7Carcinogenicity1.9PDF13,624PendingNadia Petrova
CC-10715.2.6Integrated Summary of Efficacy11.7XML5,099In ProgressMarcus Webb
CC-11714.2.5Toxicology Studies10.4PDF3,089FailedPriya Sharma
CC-12714.2.9Toxicology Studies9.1Word2,592SubmittedAisha Okonkwo
CC-13711.7.4Proposed Conditions of Approval12.6PDF8,018BlockedSarah Chen
CC-14715.4.1Integrated Summary of Efficacy11.2Word2,430FailedNadia Petrova
CC-15713.6.1Drug Substance7.9HTML2,525FailedNadia Petrova
CC-16714.2.3Pharmacokinetics Studies6.7HTML7,957PendingJames O'Brien
CC-17711.8.6Proposed Conditions of Approval4.1Word10,468ActiveNadia Petrova
CC-18715.2.7Study Reports – Efficacy2.9Word4,592PendingSarah Chen
CC-19715.7.2Integrated Summary of Safety8.3PDF5,806OverdueDmitri Volkov