Dossier DOS-041

Dossier in NeeS format, version 2.3.7, for application FDA-2024-0041. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-041
Format
NeeS
Version
2.3.7
Status
Blocked
Application
FDA-2024-0041
Created
2023-01-24
Updated
2023-04-18
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information3Active
2CTD Summaries11Active
3Quality9In Progress
4Nonclinical Study Reports5Draft
5Clinical Study Reports3Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0414.8.5Genotoxicity9.0PDF5,961CompletedCarlos Mendez
CC-1414.3.6Genotoxicity6.9HTML8,945ActiveMarcus Webb
CC-2412.4.9Clinical Overview10.2HTML7,248DraftSarah Chen
CC-3413.5.5Drug Product4.5HTML3,098DraftCarlos Mendez
CC-4412.1.4Nonclinical Overview2.5Word3,821ApprovedLieselotte van der Berg
CC-5411.2.5Cover Letter2.5PDF12,385ActiveLieselotte van der Berg
CC-6411.9.3Patient Labeling10.8Word7,637SubmittedDmitri Volkov
CC-7413.6.6Container Closure System9.8PDF14,235FailedMarcus Webb
CC-8413.2.6Drug Substance1.6PDF5,166DraftMarcus Webb
CC-9413.5.1Manufacturing Process11.5PDF905BlockedNadia Petrova
CC-10412.2.2Quality Overall Summary5.3PDF3,590In ProgressNadia Petrova
CC-11414.7.9Genotoxicity12.1Word5,807FailedDmitri Volkov
CC-12414.2.5Genotoxicity12.3HTML665CompletedDmitri Volkov
CC-13413.3.6Drug Substance2.4XML8,123OverduePriya Sharma
CC-14412.4.7Quality Overall Summary8.0XML6,783SubmittedCarlos Mendez
CC-15412.4.9Quality Overall Summary7.8HTML11,858PendingPriya Sharma
CC-16411.7.3Prescribing Information8.7Word8,161BlockedSarah Chen
CC-17412.7.7Nonclinical Overview2.5HTML1,590ActiveTomoko Ikeda
CC-18412.2.5Nonclinical Overview9.6PDF1,294DraftMarcus Webb
CC-19411.4.6Proposed Conditions of Approval7.8Word7,607FailedPriya Sharma