Dossier DOS-025

Dossier in CTD format, version 8.9.2, for application ANVISA-2020-0025. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-025
Format
CTD
Version
8.9.2
Status
Submitted
Application
ANVISA-2020-0025
Created
2022-12-03
Updated
2024-03-02
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information15Blocked
2CTD Summaries6Approved
3Quality5Draft
4Nonclinical Study Reports3Draft
5Clinical Study Reports15Active
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0252.8.7Clinical Overview9.5HTML6,118In ProgressPriya Sharma
CC-1252.1.5Nonclinical Summary10.8Word14,799CompletedNadia Petrova
CC-2253.7.1Manufacturing Process8.1XML5,615OverdueAisha Okonkwo
CC-3254.8.8Genotoxicity9.1PDF6,428BlockedSarah Chen
CC-4255.7.4Study Reports – Safety12.2Word3,062OverdueTomoko Ikeda
CC-5254.4.1Toxicology Studies9.0Word10,235In ProgressDmitri Volkov
CC-6253.2.5Analytical Methods6.6HTML14,365CompletedAisha Okonkwo
CC-7253.9.9Drug Substance12.7PDF4,916FailedSarah Chen
CC-8254.6.2Pharmacology Studies4.4XML9,234ActivePriya Sharma
CC-9255.5.9Integrated Summary of Efficacy1.7Word7,324OverdueDmitri Volkov
CC-10255.5.8Study Reports – Safety8.0PDF3,175In ProgressNadia Petrova
CC-11255.3.3Study Reports – Safety5.6PDF7,254CompletedJames O'Brien
CC-12253.7.2Container Closure System3.9XML6,101CompletedJames O'Brien
CC-13255.3.1Study Reports – Clinical Pharmacology3.9Word14,757DraftPriya Sharma
CC-14251.6.8Prescribing Information9.1HTML10,009OverdueLieselotte van der Berg
CC-15255.4.8Integrated Summary of Safety9.3HTML13,366ApprovedAisha Okonkwo
CC-16252.6.9Nonclinical Summary10.8HTML11,703FailedJames O'Brien
CC-17254.2.5Toxicology Studies9.6Word13,794CompletedDmitri Volkov
CC-18255.9.4Integrated Summary of Efficacy3.9Word3,447PendingDmitri Volkov
CC-19253.7.1Stability Data8.7XML3,025CompletedPriya Sharma