Dossier DOS-084

Dossier in CTD format, version 3.6.2, for application NMPA-2021-0084. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-084
Format
CTD
Version
3.6.2
Status
In Progress
Application
NMPA-2021-0084
Created
2022-11-06
Updated
2023-03-25
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information15Overdue
2CTD Summaries6In Progress
3Quality5Submitted
4Nonclinical Study Reports10Submitted
5Clinical Study Reports9Pending
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0845.9.5Study Reports – Safety10.1Word13,332FailedTomoko Ikeda
CC-1845.8.7Study Reports – Safety9.5HTML4,198CompletedSarah Chen
CC-2845.9.9Study Reports – Clinical Pharmacology9.9XML10,156FailedAisha Okonkwo
CC-3842.4.9Quality Overall Summary2.0Word3,350ActiveMarcus Webb
CC-4845.5.7Integrated Summary of Efficacy4.9PDF8,870PendingLieselotte van der Berg
CC-5843.9.7Container Closure System11.4HTML3,307OverdueNadia Petrova
CC-6841.5.2Application Form12.8PDF9,296ApprovedPriya Sharma
CC-7841.6.4Prescribing Information1.3Word909CompletedSarah Chen
CC-8841.8.7Proposed Conditions of Approval5.9Word1,903In ProgressDmitri Volkov
CC-9843.3.7Drug Substance12.9XML3,002FailedTomoko Ikeda
CC-10843.8.4Stability Data6.4HTML11,289OverdueAisha Okonkwo
CC-11841.7.4Cover Letter2.3HTML4,692In ProgressNadia Petrova
CC-12841.9.1Proposed Conditions of Approval11.2Word4,019DraftJames O'Brien
CC-13842.1.2Quality Overall Summary10.6XML4,173CompletedNadia Petrova
CC-14844.7.2Pharmacology Studies12.3Word8,813BlockedJames O'Brien
CC-15843.9.3Container Closure System3.0PDF13,564CompletedCarlos Mendez
CC-16842.1.4Nonclinical Summary6.5PDF13,758PendingMarcus Webb
CC-17842.4.2Quality Overall Summary10.7PDF567BlockedAisha Okonkwo
CC-18843.5.5Drug Product10.9Word10,500ActiveCarlos Mendez
CC-19845.5.5Study Reports – Clinical Pharmacology10.4XML8,889DraftLieselotte van der Berg