Dossier DOS-065

Dossier in CTD format, version 1.7.3, for application ANVISA-2020-0065. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-065
Format
CTD
Version
1.7.3
Status
Completed
Application
ANVISA-2020-0065
Created
2022-06-01
Updated
2024-05-05
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information9Overdue
2CTD Summaries15Submitted
3Quality13Submitted
4Nonclinical Study Reports7Pending
5Clinical Study Reports9Draft
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0651.8.2Proposed Conditions of Approval2.9XML8,172PendingPriya Sharma
CC-1655.6.1Integrated Summary of Safety3.7XML11,229In ProgressNadia Petrova
CC-2651.7.6Prescribing Information7.8PDF8,656ApprovedDmitri Volkov
CC-3652.7.5Clinical Overview7.9HTML12,191In ProgressAisha Okonkwo
CC-4654.2.9Pharmacology Studies7.8HTML892ApprovedTomoko Ikeda
CC-5653.1.1Manufacturing Process6.5Word12,533FailedDmitri Volkov
CC-6651.5.3Proposed Conditions of Approval12.8PDF13,513ActiveAisha Okonkwo
CC-7652.5.1Nonclinical Summary7.7XML13,144ActiveDmitri Volkov
CC-8654.9.7Genotoxicity4.0XML6,482OverduePriya Sharma
CC-9652.3.7Clinical Overview8.3Word5,858SubmittedMarcus Webb
CC-10653.2.3Analytical Methods7.5PDF13,703BlockedAisha Okonkwo
CC-11654.1.4Pharmacokinetics Studies12.5XML6,550OverdueAisha Okonkwo
CC-12654.6.4Pharmacology Studies6.8XML925OverduePriya Sharma
CC-13653.5.8Manufacturing Process3.9Word10,862PendingCarlos Mendez
CC-14654.9.9Pharmacokinetics Studies12.6HTML1,917DraftSarah Chen
CC-15652.5.8Quality Overall Summary6.3Word3,170ApprovedMarcus Webb
CC-16654.2.9Toxicology Studies7.0PDF10,719PendingPriya Sharma
CC-17655.2.6Study Reports – Safety3.1HTML7,401DraftLieselotte van der Berg
CC-18655.6.4Study Reports – Clinical Pharmacology10.6PDF9,355CompletedJames O'Brien
CC-19654.8.6Pharmacology Studies6.7Word4,606BlockedSarah Chen