Dossier DOS-034

Dossier in CTD format, version 6.3.2, for application COFEPRIS-2021-0034. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-034
Format
CTD
Version
6.3.2
Status
Approved
Application
COFEPRIS-2021-0034
Created
2022-11-25
Updated
2023-06-04
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information8Pending
2CTD Summaries10Overdue
3Quality3Overdue
4Nonclinical Study Reports7Draft
5Clinical Study Reports6Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0344.7.8Genotoxicity8.4HTML14,595BlockedCarlos Mendez
CC-1342.4.1Nonclinical Overview3.5Word7,154BlockedTomoko Ikeda
CC-2343.5.6Analytical Methods12.7PDF5,919ApprovedAisha Okonkwo
CC-3345.1.4Study Reports – Clinical Pharmacology2.6Word6,313ApprovedDmitri Volkov
CC-4341.5.8Application Form5.8HTML6,453BlockedLieselotte van der Berg
CC-5343.6.2Manufacturing Process2.2XML6,103In ProgressNadia Petrova
CC-6341.3.8Application Form5.4HTML3,724SubmittedSarah Chen
CC-7342.6.6Clinical Summary10.6HTML7,758ApprovedCarlos Mendez
CC-8341.9.8Proposed Conditions of Approval7.1Word11,388In ProgressMarcus Webb
CC-9345.6.5Study Reports – Clinical Pharmacology10.4HTML3,335DraftPriya Sharma
CC-10345.3.8Study Reports – Efficacy11.5PDF1,893DraftNadia Petrova
CC-11344.7.5Genotoxicity7.0PDF12,975In ProgressAisha Okonkwo
CC-12341.1.7Proposed Conditions of Approval1.8Word12,175In ProgressPriya Sharma
CC-13344.1.5Carcinogenicity10.0Word13,077BlockedCarlos Mendez
CC-14342.3.9Clinical Overview11.8Word6,810SubmittedPriya Sharma
CC-15345.6.1Integrated Summary of Safety12.4XML7,420SubmittedCarlos Mendez
CC-16344.4.6Genotoxicity1.6HTML2,070CompletedMarcus Webb
CC-17342.5.3Clinical Summary10.5HTML12,352ApprovedDmitri Volkov
CC-18343.7.4Appendices1.8HTML557FailedSarah Chen
CC-19345.7.5Integrated Summary of Safety7.1Word1,053PendingMarcus Webb