Dossier DOS-052

Dossier in CTD format, version 1.4.6, for application HSA-2023-0052. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-052
Format
CTD
Version
1.4.6
Status
In Progress
Application
HSA-2023-0052
Created
2022-01-31
Updated
2024-04-24
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information8Blocked
2CTD Summaries4Pending
3Quality6Draft
4Nonclinical Study Reports14Overdue
5Clinical Study Reports6Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0522.8.2Nonclinical Overview4.8PDF14,639FailedJames O'Brien
CC-1523.7.4Container Closure System1.1PDF2,164BlockedJames O'Brien
CC-2523.2.3Manufacturing Process10.6Word14,595In ProgressSarah Chen
CC-3525.1.3Integrated Summary of Efficacy9.8Word4,225CompletedLieselotte van der Berg
CC-4522.4.3Nonclinical Summary10.4HTML12,040DraftCarlos Mendez
CC-5524.5.6Pharmacology Studies7.1Word9,238DraftJames O'Brien
CC-6523.7.8Drug Product11.7XML7,177ActiveNadia Petrova
CC-7522.3.7Nonclinical Summary9.6Word12,929FailedMarcus Webb
CC-8524.8.7Pharmacology Studies1.9PDF8,287DraftMarcus Webb
CC-9522.4.4Clinical Overview1.9XML8,195CompletedJames O'Brien
CC-10523.1.5Appendices7.9PDF8,084ApprovedNadia Petrova
CC-11525.4.8Integrated Summary of Safety12.5XML6,762OverduePriya Sharma
CC-12523.7.8Manufacturing Process11.4PDF11,098OverdueJames O'Brien
CC-13523.3.5Stability Data5.1PDF4,331CompletedDmitri Volkov
CC-14524.1.4Toxicology Studies11.9PDF14,387In ProgressCarlos Mendez
CC-15525.2.7Study Reports – Efficacy11.7Word8,348ActiveSarah Chen
CC-16521.2.5Prescribing Information8.4HTML7,418In ProgressLieselotte van der Berg
CC-17522.8.2Nonclinical Summary3.8Word6,628BlockedPriya Sharma
CC-18523.5.8Stability Data8.1HTML5,609FailedLieselotte van der Berg
CC-19525.6.6Integrated Summary of Efficacy11.9Word6,233In ProgressCarlos Mendez