Dossier DOS-098

Dossier in eCTD format, version 3.4.1, for application SAHPRA-2022-0098. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-098
Format
eCTD
Version
3.4.1
Status
Submitted
Application
SAHPRA-2022-0098
Created
2022-04-21
Updated
2023-03-26
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information6Draft
2CTD Summaries5Failed
3Quality6Draft
4Nonclinical Study Reports4In Progress
5Clinical Study Reports6Overdue
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0984.4.2Pharmacokinetics Studies12.7HTML5,679SubmittedJames O'Brien
CC-1984.3.5Carcinogenicity10.4PDF2,902PendingLieselotte van der Berg
CC-2982.7.7Clinical Overview7.7PDF8,474ActiveAisha Okonkwo
CC-3983.4.6Analytical Methods2.1PDF10,029SubmittedAisha Okonkwo
CC-4985.8.5Study Reports – Safety3.8XML6,026DraftTomoko Ikeda
CC-5981.6.1Cover Letter8.2HTML9,435SubmittedJames O'Brien
CC-6982.4.5Quality Overall Summary7.4PDF12,578BlockedCarlos Mendez
CC-7984.4.7Pharmacology Studies3.1HTML4,902ActiveLieselotte van der Berg
CC-8984.2.8Carcinogenicity5.1XML2,942In ProgressNadia Petrova
CC-9982.3.1Nonclinical Summary4.5Word12,376OverdueMarcus Webb
CC-10982.2.1Nonclinical Summary3.4XML8,338In ProgressDmitri Volkov
CC-11982.1.5Quality Overall Summary9.3PDF11,770SubmittedMarcus Webb
CC-12984.4.1Carcinogenicity11.5PDF3,940ApprovedNadia Petrova
CC-13984.2.7Carcinogenicity3.4XML1,378OverdueNadia Petrova
CC-14983.9.2Analytical Methods12.4Word1,098CompletedNadia Petrova
CC-15981.2.1Application Form3.1XML9,135DraftSarah Chen
CC-16981.5.9Proposed Conditions of Approval12.7XML9,256SubmittedNadia Petrova
CC-17985.9.3Study Reports – Efficacy3.8Word717PendingLieselotte van der Berg
CC-18984.5.5Carcinogenicity5.8XML13,205SubmittedDmitri Volkov
CC-19984.1.8Carcinogenicity7.7PDF5,662FailedTomoko Ikeda