Dossier DOS-039

Dossier in NeeS format, version 6.9.6, for application Roszdravnadzor-2021-0039. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-039
Format
NeeS
Version
6.9.6
Status
Draft
Application
Roszdravnadzor-2021-0039
Created
2022-05-02
Updated
2023-08-18
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information14Completed
2CTD Summaries6Pending
3Quality7Approved
4Nonclinical Study Reports9In Progress
5Clinical Study Reports14Failed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0393.7.9Appendices5.2HTML2,543ActivePriya Sharma
CC-1393.2.5Manufacturing Process12.6PDF2,657OverdueNadia Petrova
CC-2391.1.1Application Form2.3HTML3,225SubmittedAisha Okonkwo
CC-3392.1.2Quality Overall Summary1.3Word12,699DraftTomoko Ikeda
CC-4395.9.2Integrated Summary of Efficacy11.4Word14,803PendingTomoko Ikeda
CC-5395.5.7Study Reports – Clinical Pharmacology7.6XML2,224CompletedSarah Chen
CC-6395.7.6Integrated Summary of Efficacy1.6PDF5,825In ProgressDmitri Volkov
CC-7394.2.7Pharmacokinetics Studies12.4PDF3,988ApprovedDmitri Volkov
CC-8392.9.5Clinical Overview3.5XML12,379BlockedDmitri Volkov
CC-9394.7.6Genotoxicity8.7Word8,202OverduePriya Sharma
CC-10394.8.5Genotoxicity12.0HTML13,060PendingPriya Sharma
CC-11395.5.6Study Reports – Safety2.6Word9,966ActiveAisha Okonkwo
CC-12391.3.1Application Form1.9HTML11,975DraftDmitri Volkov
CC-13393.9.9Container Closure System2.1HTML13,485ApprovedPriya Sharma
CC-14391.7.4Prescribing Information7.1HTML9,181FailedPriya Sharma
CC-15394.8.1Toxicology Studies5.4XML8,758ActiveCarlos Mendez
CC-16394.7.1Toxicology Studies2.7Word14,626ApprovedSarah Chen
CC-17391.6.2Application Form11.9HTML5,777In ProgressCarlos Mendez
CC-18391.4.1Application Form9.2Word13,903BlockedLieselotte van der Berg
CC-19392.1.6Nonclinical Overview4.7PDF9,988BlockedSarah Chen