Dossier DOS-061

Dossier in NeeS format, version 5.4.2, for application FDA-2024-0061. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-061
Format
NeeS
Version
5.4.2
Status
Pending
Application
FDA-2024-0061
Created
2022-06-08
Updated
2023-10-14
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information11Submitted
2CTD Summaries9Blocked
3Quality7Approved
4Nonclinical Study Reports5Completed
5Clinical Study Reports12In Progress
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0611.3.6Patient Labeling4.6Word9,091BlockedDmitri Volkov
CC-1612.9.5Nonclinical Summary3.6PDF6,152CompletedTomoko Ikeda
CC-2612.4.6Clinical Overview4.4Word4,406BlockedLieselotte van der Berg
CC-3614.7.8Pharmacology Studies11.5PDF13,163BlockedLieselotte van der Berg
CC-4612.4.4Clinical Overview2.5HTML12,629In ProgressPriya Sharma
CC-5615.2.2Study Reports – Efficacy4.3HTML926ActiveCarlos Mendez
CC-6614.7.6Toxicology Studies11.8PDF12,927In ProgressDmitri Volkov
CC-7615.8.4Study Reports – Efficacy10.2PDF13,339ActiveMarcus Webb
CC-8612.6.8Clinical Summary7.0XML10,271In ProgressTomoko Ikeda
CC-9614.6.9Genotoxicity9.7Word3,550ActiveMarcus Webb
CC-10615.5.4Integrated Summary of Safety5.7HTML4,671DraftLieselotte van der Berg
CC-11612.2.6Clinical Overview5.5HTML4,243DraftLieselotte van der Berg
CC-12612.7.5Nonclinical Summary10.9HTML1,421PendingSarah Chen
CC-13611.8.8Patient Labeling1.8Word9,752ApprovedLieselotte van der Berg
CC-14612.8.3Nonclinical Overview9.0HTML4,941PendingJames O'Brien
CC-15614.2.6Toxicology Studies5.8Word13,823PendingDmitri Volkov
CC-16613.7.9Drug Substance11.1Word5,984ApprovedLieselotte van der Berg
CC-17615.3.7Integrated Summary of Safety11.8Word5,607ActiveJames O'Brien
CC-18611.9.6Prescribing Information11.0XML9,956BlockedJames O'Brien
CC-19612.3.9Quality Overall Summary6.6XML10,398BlockedTomoko Ikeda