Dossier DOS-078

Dossier in eCTD format, version 7.0.2, for application SAHPRA-2022-0078. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-078
Format
eCTD
Version
7.0.2
Status
Overdue
Application
SAHPRA-2022-0078
Created
2022-04-21
Updated
2023-06-25
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information3Active
2CTD Summaries13Approved
3Quality12Draft
4Nonclinical Study Reports11In Progress
5Clinical Study Reports7Submitted
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0783.5.5Stability Data7.3XML7,437BlockedNadia Petrova
CC-1784.4.3Pharmacology Studies7.7Word7,343FailedPriya Sharma
CC-2783.4.9Appendices9.8Word4,457OverdueJames O'Brien
CC-3784.5.8Pharmacology Studies9.7Word14,610In ProgressCarlos Mendez
CC-4784.1.5Carcinogenicity11.1HTML14,165CompletedSarah Chen
CC-5785.5.5Integrated Summary of Efficacy4.0XML3,286FailedCarlos Mendez
CC-6784.5.2Carcinogenicity12.3HTML2,638FailedPriya Sharma
CC-7784.5.2Genotoxicity6.8Word5,012FailedAisha Okonkwo
CC-8781.1.8Proposed Conditions of Approval12.3PDF11,369FailedTomoko Ikeda
CC-9785.9.3Study Reports – Clinical Pharmacology11.7XML8,510BlockedSarah Chen
CC-10783.5.2Drug Substance11.3Word4,054OverdueAisha Okonkwo
CC-11781.2.8Proposed Conditions of Approval8.7XML13,927ActiveMarcus Webb
CC-12783.5.4Appendices3.9PDF10,183SubmittedNadia Petrova
CC-13783.2.6Appendices1.8XML9,373OverduePriya Sharma
CC-14784.5.4Toxicology Studies5.2XML12,936PendingAisha Okonkwo
CC-15781.1.9Patient Labeling12.0XML14,742BlockedTomoko Ikeda
CC-16781.2.1Cover Letter6.8PDF14,788SubmittedPriya Sharma
CC-17784.7.3Genotoxicity3.2HTML12,177CompletedAisha Okonkwo
CC-18785.8.7Study Reports – Clinical Pharmacology11.0PDF9,162FailedLieselotte van der Berg
CC-19784.1.4Carcinogenicity12.8HTML3,885ApprovedLieselotte van der Berg