Dossier DOS-092

Dossier in NeeS format, version 3.4.1, for application HSA-2023-0092. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-092
Format
NeeS
Version
3.4.1
Status
Blocked
Application
HSA-2023-0092
Created
2022-10-23
Updated
2023-06-11
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information9In Progress
2CTD Summaries12Completed
3Quality10Failed
4Nonclinical Study Reports14In Progress
5Clinical Study Reports9Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0921.5.7Application Form6.6XML10,806DraftJames O'Brien
CC-1921.5.8Proposed Conditions of Approval3.6PDF7,583In ProgressTomoko Ikeda
CC-2923.5.8Container Closure System4.6XML8,649CompletedSarah Chen
CC-3924.9.7Pharmacokinetics Studies8.3PDF13,155FailedJames O'Brien
CC-4921.9.6Proposed Conditions of Approval10.4XML5,384ApprovedLieselotte van der Berg
CC-5925.6.7Integrated Summary of Safety5.7XML8,382In ProgressNadia Petrova
CC-6923.9.1Stability Data2.2Word7,350ApprovedJames O'Brien
CC-7925.1.8Integrated Summary of Efficacy4.8Word8,248ActivePriya Sharma
CC-8922.9.6Clinical Summary12.7HTML5,039ApprovedMarcus Webb
CC-9925.3.9Integrated Summary of Efficacy2.0PDF12,054ApprovedLieselotte van der Berg
CC-10922.4.8Nonclinical Overview1.0XML10,891OverdueAisha Okonkwo
CC-11925.1.7Study Reports – Clinical Pharmacology7.3HTML1,229ActiveJames O'Brien
CC-12923.3.6Analytical Methods5.4Word11,696FailedTomoko Ikeda
CC-13923.8.4Drug Product4.9Word2,941PendingJames O'Brien
CC-14925.5.6Study Reports – Safety6.6PDF3,921PendingSarah Chen
CC-15925.5.1Study Reports – Safety1.9XML9,240PendingNadia Petrova
CC-16924.8.1Genotoxicity11.6PDF1,925DraftSarah Chen
CC-17923.6.9Analytical Methods1.1Word5,335In ProgressMarcus Webb
CC-18922.2.4Clinical Overview8.9HTML1,918OverdueAisha Okonkwo
CC-19923.9.5Drug Product1.1Word9,563DraftDmitri Volkov