Dossier DOS-085

Dossier in eCTD format, version 5.6.9, for application ANVISA-2020-0085. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-085
Format
eCTD
Version
5.6.9
Status
Active
Application
ANVISA-2020-0085
Created
2022-07-08
Updated
2024-05-29
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information14Submitted
2CTD Summaries13Completed
3Quality9Failed
4Nonclinical Study Reports9Pending
5Clinical Study Reports4Failed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0855.1.7Integrated Summary of Efficacy3.2HTML4,388ApprovedTomoko Ikeda
CC-1852.8.7Nonclinical Summary9.0XML9,321ApprovedPriya Sharma
CC-2852.5.1Nonclinical Summary6.6Word7,793FailedMarcus Webb
CC-3851.9.9Application Form5.0Word5,542ActiveLieselotte van der Berg
CC-4851.3.5Prescribing Information12.2HTML6,891DraftPriya Sharma
CC-5855.6.9Study Reports – Safety4.1XML14,657BlockedAisha Okonkwo
CC-6852.9.3Clinical Summary10.5HTML14,599FailedAisha Okonkwo
CC-7854.7.9Genotoxicity12.6HTML5,389SubmittedDmitri Volkov
CC-8851.6.5Application Form11.6XML6,337SubmittedDmitri Volkov
CC-9855.1.4Study Reports – Clinical Pharmacology3.3PDF14,598DraftJames O'Brien
CC-10854.6.5Toxicology Studies8.5XML9,617In ProgressTomoko Ikeda
CC-11853.2.1Drug Substance7.6HTML6,558FailedMarcus Webb
CC-12853.5.3Analytical Methods6.3HTML4,531FailedSarah Chen
CC-13852.9.2Clinical Overview4.1Word11,321ApprovedPriya Sharma
CC-14854.7.6Genotoxicity6.8PDF4,228OverdueAisha Okonkwo
CC-15855.8.1Integrated Summary of Safety9.1PDF12,736CompletedSarah Chen
CC-16855.8.8Integrated Summary of Efficacy12.9XML11,023CompletedAisha Okonkwo
CC-17854.6.4Toxicology Studies4.5HTML14,118ActivePriya Sharma
CC-18855.3.7Study Reports – Efficacy11.9PDF2,676ActiveNadia Petrova
CC-19852.7.8Clinical Summary10.6PDF6,751ActiveNadia Petrova