Dossier DOS-059

Dossier in NeeS format, version 1.3.9, for application Roszdravnadzor-2021-0059. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-059
Format
NeeS
Version
1.3.9
Status
Submitted
Application
Roszdravnadzor-2021-0059
Created
2022-12-25
Updated
2023-04-21
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information9Active
2CTD Summaries9In Progress
3Quality4Blocked
4Nonclinical Study Reports9Completed
5Clinical Study Reports11Approved
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0591.6.4Application Form10.5HTML1,282CompletedSarah Chen
CC-1593.7.1Stability Data11.9PDF11,582PendingCarlos Mendez
CC-2591.8.1Application Form3.0Word1,238FailedTomoko Ikeda
CC-3592.6.4Nonclinical Summary3.0XML7,953ActiveNadia Petrova
CC-4591.9.5Proposed Conditions of Approval9.8HTML3,358OverdueMarcus Webb
CC-5592.8.9Clinical Summary8.5Word3,991BlockedMarcus Webb
CC-6592.8.4Nonclinical Summary6.6Word5,148SubmittedPriya Sharma
CC-7591.8.9Cover Letter8.5Word1,147CompletedAisha Okonkwo
CC-8595.1.9Study Reports – Clinical Pharmacology1.0Word14,435OverdueTomoko Ikeda
CC-9593.9.7Drug Product9.6Word9,129ActivePriya Sharma
CC-10591.5.4Patient Labeling8.7XML1,605DraftNadia Petrova
CC-11591.6.5Prescribing Information9.5HTML12,797ApprovedJames O'Brien
CC-12591.9.6Application Form9.0XML6,081ActiveLieselotte van der Berg
CC-13592.7.4Nonclinical Summary11.6Word7,337BlockedTomoko Ikeda
CC-14595.1.6Integrated Summary of Safety10.3HTML7,376ActivePriya Sharma
CC-15595.5.2Study Reports – Clinical Pharmacology1.3XML4,396CompletedJames O'Brien
CC-16593.7.8Appendices8.2HTML2,087OverdueAisha Okonkwo
CC-17592.4.3Nonclinical Summary3.8HTML5,591DraftNadia Petrova
CC-18595.4.2Study Reports – Efficacy3.7XML7,491BlockedSarah Chen
CC-19595.8.1Study Reports – Efficacy3.5Word6,944SubmittedCarlos Mendez