Dossier DOS-017

Dossier in NeeS format, version 1.9.2, for application SFDA-2023-0017. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-017
Format
NeeS
Version
1.9.2
Status
Approved
Application
SFDA-2023-0017
Created
2022-11-13
Updated
2023-11-22
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information8Draft
2CTD Summaries10Blocked
3Quality7Failed
4Nonclinical Study Reports6Pending
5Clinical Study Reports14Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0174.7.9Genotoxicity9.8XML8,360OverduePriya Sharma
CC-1173.8.8Container Closure System10.9XML4,721In ProgressPriya Sharma
CC-2171.9.6Cover Letter7.6XML1,556FailedLieselotte van der Berg
CC-3172.2.3Nonclinical Summary3.7XML1,254BlockedTomoko Ikeda
CC-4173.1.5Analytical Methods11.6HTML4,767OverduePriya Sharma
CC-5175.6.5Integrated Summary of Efficacy6.6PDF9,544ApprovedAisha Okonkwo
CC-6173.9.2Appendices6.7HTML2,126ApprovedLieselotte van der Berg
CC-7175.6.8Integrated Summary of Efficacy4.4XML4,628BlockedSarah Chen
CC-8173.6.2Analytical Methods1.5Word14,019In ProgressPriya Sharma
CC-9172.3.6Clinical Overview11.9HTML13,031CompletedMarcus Webb
CC-10173.6.2Drug Product1.3PDF2,253ActiveLieselotte van der Berg
CC-11173.7.7Manufacturing Process12.2HTML4,012OverdueAisha Okonkwo
CC-12171.5.2Prescribing Information4.2Word7,048CompletedJames O'Brien
CC-13171.6.2Application Form4.4Word3,974SubmittedSarah Chen
CC-14173.9.5Drug Product2.5PDF13,708ApprovedSarah Chen
CC-15174.8.7Genotoxicity5.8PDF7,069CompletedNadia Petrova
CC-16173.4.1Manufacturing Process7.7XML6,244SubmittedNadia Petrova
CC-17172.6.5Clinical Summary1.1HTML12,415ActiveAisha Okonkwo
CC-18175.8.4Integrated Summary of Safety8.7Word3,609OverdueAisha Okonkwo
CC-19173.8.1Manufacturing Process10.3Word4,980SubmittedNadia Petrova