Dossier DOS-021

Dossier in CTD format, version 4.9.0, for application FDA-2024-0021. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-021
Format
CTD
Version
4.9.0
Status
Submitted
Application
FDA-2024-0021
Created
2022-03-23
Updated
2024-04-19
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information6Active
2CTD Summaries6Completed
3Quality14Overdue
4Nonclinical Study Reports9Blocked
5Clinical Study Reports3Active
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0212.9.2Clinical Summary2.3XML5,490OverdueTomoko Ikeda
CC-1215.1.1Study Reports – Clinical Pharmacology4.2HTML5,424DraftAisha Okonkwo
CC-2212.3.5Nonclinical Summary1.8PDF5,214ActivePriya Sharma
CC-3215.2.4Study Reports – Clinical Pharmacology7.4XML2,932DraftLieselotte van der Berg
CC-4211.3.7Patient Labeling5.3PDF5,764PendingNadia Petrova
CC-5214.3.4Pharmacokinetics Studies12.0HTML13,841BlockedSarah Chen
CC-6211.9.4Patient Labeling5.3PDF979ActiveCarlos Mendez
CC-7215.9.4Study Reports – Efficacy4.0XML7,154BlockedLieselotte van der Berg
CC-8211.2.5Proposed Conditions of Approval1.4XML2,125CompletedDmitri Volkov
CC-9213.5.9Stability Data4.6XML1,200ApprovedLieselotte van der Berg
CC-10214.3.7Pharmacology Studies3.1PDF11,267FailedAisha Okonkwo
CC-11212.3.4Nonclinical Summary3.0XML4,198PendingAisha Okonkwo
CC-12215.1.1Study Reports – Clinical Pharmacology10.6PDF13,361CompletedLieselotte van der Berg
CC-13211.8.6Patient Labeling6.2Word7,376CompletedPriya Sharma
CC-14215.3.3Study Reports – Efficacy12.0Word2,727In ProgressJames O'Brien
CC-15211.9.4Cover Letter4.5XML13,642SubmittedDmitri Volkov
CC-16214.1.6Genotoxicity1.8Word3,157ActiveTomoko Ikeda
CC-17212.3.3Clinical Summary12.8XML14,670ActivePriya Sharma
CC-18211.5.8Application Form3.0Word12,143OverdueAisha Okonkwo
CC-19213.4.3Manufacturing Process9.1PDF8,035BlockedAisha Okonkwo