Dossier DOS-046

Dossier in CTD format, version 3.8.5, for application HC-2024-0046. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-046
Format
CTD
Version
3.8.5
Status
In Progress
Application
HC-2024-0046
Created
2022-08-01
Updated
2023-11-12
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information15Overdue
2CTD Summaries8In Progress
3Quality12Failed
4Nonclinical Study Reports11In Progress
5Clinical Study Reports7In Progress
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0465.8.2Integrated Summary of Safety10.7Word2,153SubmittedSarah Chen
CC-1465.1.2Study Reports – Efficacy12.2XML14,948In ProgressAisha Okonkwo
CC-2465.5.7Study Reports – Efficacy3.1PDF8,082OverdueMarcus Webb
CC-3464.9.5Pharmacokinetics Studies11.3HTML10,554DraftDmitri Volkov
CC-4461.1.1Proposed Conditions of Approval7.6HTML14,030DraftCarlos Mendez
CC-5462.2.4Clinical Overview5.3PDF12,571BlockedPriya Sharma
CC-6464.1.2Genotoxicity7.2Word12,337SubmittedJames O'Brien
CC-7464.7.2Toxicology Studies6.1PDF14,398PendingSarah Chen
CC-8461.1.2Proposed Conditions of Approval4.8PDF8,176ApprovedAisha Okonkwo
CC-9462.9.6Clinical Summary2.0PDF3,165ApprovedSarah Chen
CC-10463.9.8Manufacturing Process10.9Word6,892PendingAisha Okonkwo
CC-11463.2.3Drug Product12.5PDF12,682In ProgressDmitri Volkov
CC-12461.6.1Proposed Conditions of Approval10.2HTML12,004BlockedAisha Okonkwo
CC-13461.3.7Patient Labeling1.7XML14,791ApprovedDmitri Volkov
CC-14461.5.4Patient Labeling9.9Word12,998In ProgressMarcus Webb
CC-15462.3.9Clinical Summary2.8XML9,143PendingDmitri Volkov
CC-16463.1.6Appendices8.6PDF4,156DraftCarlos Mendez
CC-17461.3.8Application Form12.3Word3,370CompletedCarlos Mendez
CC-18464.5.3Pharmacokinetics Studies8.5HTML13,422In ProgressMarcus Webb
CC-19463.3.8Stability Data9.6PDF4,762In ProgressJames O'Brien