Dossier DOS-019

Dossier in CTD format, version 6.6.8, for application Roszdravnadzor-2021-0019. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-019
Format
CTD
Version
6.6.8
Status
Approved
Application
Roszdravnadzor-2021-0019
Created
2022-10-03
Updated
2023-07-30
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information11Blocked
2CTD Summaries3Overdue
3Quality9Approved
4Nonclinical Study Reports13Blocked
5Clinical Study Reports10Draft
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0192.9.8Clinical Overview1.7PDF6,603ApprovedDmitri Volkov
CC-1193.1.9Appendices3.4HTML6,057BlockedSarah Chen
CC-2195.8.9Study Reports – Clinical Pharmacology5.3PDF14,905SubmittedSarah Chen
CC-3194.9.2Pharmacokinetics Studies3.6PDF5,412CompletedNadia Petrova
CC-4193.4.8Appendices1.4HTML14,732DraftAisha Okonkwo
CC-5194.3.3Pharmacology Studies3.1XML4,811FailedSarah Chen
CC-6192.7.1Clinical Overview8.6Word10,511SubmittedCarlos Mendez
CC-7192.1.8Quality Overall Summary3.3XML6,161OverdueSarah Chen
CC-8193.6.4Analytical Methods12.1XML14,248CompletedCarlos Mendez
CC-9194.3.8Toxicology Studies2.9HTML13,903OverduePriya Sharma
CC-10194.5.9Toxicology Studies1.0XML6,514BlockedAisha Okonkwo
CC-11195.5.6Integrated Summary of Safety8.5XML4,407ApprovedAisha Okonkwo
CC-12193.1.5Drug Substance7.7Word8,162BlockedSarah Chen
CC-13195.1.7Integrated Summary of Efficacy3.7Word8,727CompletedNadia Petrova
CC-14192.6.1Clinical Overview1.4Word1,625CompletedTomoko Ikeda
CC-15195.3.1Integrated Summary of Safety10.1HTML5,847FailedSarah Chen
CC-16192.4.8Nonclinical Overview4.5PDF5,832PendingJames O'Brien
CC-17194.4.1Pharmacology Studies5.0HTML2,463FailedDmitri Volkov
CC-18191.8.1Prescribing Information5.6PDF10,024BlockedLieselotte van der Berg
CC-19191.6.1Patient Labeling2.4Word4,849CompletedNadia Petrova