Dossier DOS-079

Dossier in NeeS format, version 5.8.8, for application Roszdravnadzor-2021-0079. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-079
Format
NeeS
Version
5.8.8
Status
Failed
Application
Roszdravnadzor-2021-0079
Created
2022-04-04
Updated
2023-08-19
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information3Approved
2CTD Summaries4Blocked
3Quality14Overdue
4Nonclinical Study Reports5Pending
5Clinical Study Reports14Completed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0793.2.7Manufacturing Process10.9HTML6,463In ProgressJames O'Brien
CC-1793.8.3Manufacturing Process2.3HTML4,706BlockedDmitri Volkov
CC-2793.3.2Drug Substance10.7PDF13,174In ProgressMarcus Webb
CC-3791.2.7Proposed Conditions of Approval10.2XML4,717DraftLieselotte van der Berg
CC-4794.5.6Genotoxicity3.3XML3,668ApprovedDmitri Volkov
CC-5793.6.8Manufacturing Process1.6Word10,789CompletedDmitri Volkov
CC-6791.8.9Prescribing Information5.7Word4,514FailedNadia Petrova
CC-7791.6.6Proposed Conditions of Approval8.3PDF6,501SubmittedTomoko Ikeda
CC-8793.3.2Appendices2.9XML1,493PendingCarlos Mendez
CC-9793.8.6Stability Data12.0Word10,386ApprovedCarlos Mendez
CC-10791.7.6Prescribing Information1.8Word5,834PendingTomoko Ikeda
CC-11791.2.9Cover Letter11.5HTML5,006FailedJames O'Brien
CC-12794.5.6Pharmacology Studies9.7PDF12,646DraftCarlos Mendez
CC-13791.4.4Cover Letter7.4Word10,573DraftJames O'Brien
CC-14794.8.3Genotoxicity3.2Word14,177DraftDmitri Volkov
CC-15795.8.2Study Reports – Efficacy8.6Word12,030DraftCarlos Mendez
CC-16792.3.1Nonclinical Overview4.1PDF682ApprovedDmitri Volkov
CC-17794.1.1Toxicology Studies1.7HTML4,564DraftNadia Petrova
CC-18793.2.5Drug Product11.8PDF13,950SubmittedPriya Sharma
CC-19793.6.3Analytical Methods4.4Word8,727FailedSarah Chen