Dossier DOS-013

Dossier in eCTD format, version 6.0.6, for application CDSCO-2022-0013. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-013
Format
eCTD
Version
6.0.6
Status
In Progress
Application
CDSCO-2022-0013
Created
2022-11-24
Updated
2023-02-26
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information7Pending
2CTD Summaries4Pending
3Quality6Failed
4Nonclinical Study Reports10Active
5Clinical Study Reports12Submitted
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0134.3.5Pharmacokinetics Studies11.3XML1,807FailedCarlos Mendez
CC-1132.1.8Quality Overall Summary1.3Word12,755CompletedLieselotte van der Berg
CC-2135.4.6Integrated Summary of Safety8.4XML9,741CompletedCarlos Mendez
CC-3131.3.8Application Form10.5HTML8,706OverdueTomoko Ikeda
CC-4131.3.8Application Form5.5HTML1,643FailedAisha Okonkwo
CC-5135.2.4Study Reports – Clinical Pharmacology5.5Word9,284In ProgressTomoko Ikeda
CC-6133.7.9Drug Substance4.3XML6,012ApprovedTomoko Ikeda
CC-7135.3.7Study Reports – Safety5.0PDF14,350SubmittedLieselotte van der Berg
CC-8135.5.4Study Reports – Clinical Pharmacology3.4HTML8,761BlockedLieselotte van der Berg
CC-9134.5.7Pharmacology Studies9.5PDF8,415SubmittedMarcus Webb
CC-10133.4.7Drug Substance5.0XML5,912SubmittedCarlos Mendez
CC-11135.9.5Study Reports – Clinical Pharmacology12.2Word13,684BlockedPriya Sharma
CC-12135.5.1Study Reports – Clinical Pharmacology4.9Word9,229DraftMarcus Webb
CC-13135.4.9Study Reports – Efficacy4.9HTML6,376PendingCarlos Mendez
CC-14135.3.7Study Reports – Safety1.5PDF2,634CompletedAisha Okonkwo
CC-15132.2.4Clinical Overview12.6XML10,164CompletedPriya Sharma
CC-16135.2.6Study Reports – Efficacy11.9PDF10,740ApprovedLieselotte van der Berg
CC-17131.2.4Application Form11.1PDF14,353BlockedNadia Petrova
CC-18133.3.5Container Closure System12.5PDF10,355DraftPriya Sharma
CC-19135.8.3Study Reports – Safety5.9HTML2,489In ProgressCarlos Mendez