Dossier DOS-018

Dossier in NeeS format, version 8.7.2, for application SAHPRA-2022-0018. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-018
Format
NeeS
Version
8.7.2
Status
Approved
Application
SAHPRA-2022-0018
Created
2022-09-27
Updated
2023-12-30
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information6Overdue
2CTD Summaries7Submitted
3Quality3Failed
4Nonclinical Study Reports6In Progress
5Clinical Study Reports5Submitted
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0184.5.7Pharmacology Studies4.1HTML4,501BlockedAisha Okonkwo
CC-1181.5.3Proposed Conditions of Approval6.8XML6,263FailedJames O'Brien
CC-2184.7.7Toxicology Studies5.7HTML11,175ApprovedMarcus Webb
CC-3184.7.8Pharmacokinetics Studies12.3HTML7,780CompletedMarcus Webb
CC-4182.2.2Quality Overall Summary12.5Word13,158FailedCarlos Mendez
CC-5181.5.5Proposed Conditions of Approval6.3Word1,431ActiveLieselotte van der Berg
CC-6183.7.3Container Closure System12.4HTML12,904In ProgressTomoko Ikeda
CC-7184.7.9Toxicology Studies7.6HTML14,381SubmittedDmitri Volkov
CC-8184.1.2Pharmacology Studies8.9HTML5,499In ProgressCarlos Mendez
CC-9183.8.4Container Closure System4.9Word11,954OverdueSarah Chen
CC-10181.4.3Cover Letter9.7PDF12,329ApprovedDmitri Volkov
CC-11184.1.5Carcinogenicity6.7Word8,029OverdueNadia Petrova
CC-12185.5.3Study Reports – Efficacy10.7Word1,511ActiveSarah Chen
CC-13184.2.5Pharmacology Studies1.5HTML8,770ActiveNadia Petrova
CC-14184.9.4Genotoxicity5.5Word11,088ActivePriya Sharma
CC-15185.5.8Study Reports – Safety9.7Word7,551ActiveAisha Okonkwo
CC-16183.6.3Appendices10.9HTML8,853BlockedLieselotte van der Berg
CC-17181.2.6Prescribing Information5.5XML1,746PendingDmitri Volkov
CC-18181.3.4Patient Labeling2.6Word11,706FailedNadia Petrova
CC-19183.6.9Container Closure System10.8HTML502OverdueJames O'Brien