Dossier DOS-024

Dossier in CTD format, version 3.9.5, for application NMPA-2021-0024. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-024
Format
CTD
Version
3.9.5
Status
Approved
Application
NMPA-2021-0024
Created
2022-05-12
Updated
2024-04-16
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information9Active
2CTD Summaries11Overdue
3Quality4Active
4Nonclinical Study Reports11Submitted
5Clinical Study Reports13Overdue
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0245.2.3Study Reports – Efficacy1.3XML8,946OverdueSarah Chen
CC-1245.6.1Integrated Summary of Safety10.4XML656SubmittedSarah Chen
CC-2243.1.9Stability Data5.2Word10,811ActiveCarlos Mendez
CC-3241.5.5Application Form11.2XML2,790PendingCarlos Mendez
CC-4242.3.9Clinical Overview11.7XML12,592ApprovedCarlos Mendez
CC-5243.2.4Drug Substance8.0Word12,824FailedLieselotte van der Berg
CC-6242.2.8Nonclinical Overview2.6HTML14,322SubmittedDmitri Volkov
CC-7244.2.4Pharmacology Studies4.7Word6,898OverduePriya Sharma
CC-8245.8.2Study Reports – Clinical Pharmacology7.3XML5,434FailedLieselotte van der Berg
CC-9245.6.9Study Reports – Efficacy12.9XML13,354In ProgressCarlos Mendez
CC-10241.9.1Proposed Conditions of Approval1.8Word6,770DraftTomoko Ikeda
CC-11243.7.2Appendices8.5HTML4,376SubmittedDmitri Volkov
CC-12241.3.2Prescribing Information7.8Word11,187DraftJames O'Brien
CC-13245.9.2Study Reports – Clinical Pharmacology11.0XML12,485In ProgressNadia Petrova
CC-14245.8.4Study Reports – Safety2.0XML4,017OverdueDmitri Volkov
CC-15242.8.9Nonclinical Summary3.6PDF1,677CompletedAisha Okonkwo
CC-16243.2.1Container Closure System1.3PDF7,139SubmittedAisha Okonkwo
CC-17245.8.7Integrated Summary of Efficacy10.5HTML10,948PendingMarcus Webb
CC-18245.2.6Study Reports – Efficacy1.9XML9,211In ProgressJames O'Brien
CC-19245.7.2Integrated Summary of Efficacy7.3XML10,588FailedLieselotte van der Berg