Dossier DOS-058

Dossier in NeeS format, version 6.8.7, for application SAHPRA-2022-0058. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-058
Format
NeeS
Version
6.8.7
Status
Submitted
Application
SAHPRA-2022-0058
Created
2022-08-24
Updated
2024-01-01
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information14Blocked
2CTD Summaries3In Progress
3Quality8Approved
4Nonclinical Study Reports15Active
5Clinical Study Reports9Failed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0581.5.2Prescribing Information7.7HTML6,388DraftPriya Sharma
CC-1585.9.4Study Reports – Safety9.4PDF1,844CompletedNadia Petrova
CC-2582.6.7Nonclinical Overview8.8XML5,088ApprovedPriya Sharma
CC-3581.5.7Application Form1.2Word3,873DraftAisha Okonkwo
CC-4581.6.6Cover Letter10.2Word7,333ActivePriya Sharma
CC-5585.5.6Integrated Summary of Efficacy3.2XML10,501SubmittedJames O'Brien
CC-6585.5.5Integrated Summary of Efficacy3.2HTML9,673BlockedMarcus Webb
CC-7581.4.6Proposed Conditions of Approval3.2XML12,057In ProgressNadia Petrova
CC-8585.9.1Integrated Summary of Safety10.7HTML13,027ApprovedDmitri Volkov
CC-9581.5.7Application Form6.9PDF12,977ApprovedMarcus Webb
CC-10582.1.3Nonclinical Overview6.5Word6,541In ProgressDmitri Volkov
CC-11581.1.3Prescribing Information11.2PDF6,331SubmittedLieselotte van der Berg
CC-12585.6.3Integrated Summary of Safety9.0XML2,783ActiveNadia Petrova
CC-13581.5.6Patient Labeling12.2PDF11,084SubmittedJames O'Brien
CC-14583.3.6Analytical Methods9.6Word9,358OverdueSarah Chen
CC-15582.7.6Quality Overall Summary10.6HTML13,393DraftSarah Chen
CC-16585.6.9Integrated Summary of Safety5.5XML11,696BlockedDmitri Volkov
CC-17584.3.5Toxicology Studies12.0XML8,267FailedAisha Okonkwo
CC-18583.9.4Analytical Methods1.4PDF14,596ActiveMarcus Webb
CC-19584.1.9Pharmacology Studies12.0PDF13,770FailedPriya Sharma