Dossier DOS-072

Dossier in CTD format, version 1.5.0, for application HSA-2023-0072. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-072
Format
CTD
Version
1.5.0
Status
Completed
Application
HSA-2023-0072
Created
2022-08-22
Updated
2023-10-06
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information5Active
2CTD Summaries11Failed
3Quality14Overdue
4Nonclinical Study Reports8Blocked
5Clinical Study Reports7Failed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0725.4.6Study Reports – Efficacy4.0XML12,569CompletedJames O'Brien
CC-1721.1.3Prescribing Information10.7PDF4,485SubmittedNadia Petrova
CC-2725.2.6Study Reports – Efficacy5.7HTML8,223BlockedNadia Petrova
CC-3722.3.7Nonclinical Summary3.4PDF5,500DraftSarah Chen
CC-4721.9.5Proposed Conditions of Approval12.7XML14,087FailedCarlos Mendez
CC-5722.8.1Nonclinical Overview3.6HTML11,065In ProgressAisha Okonkwo
CC-6721.7.1Patient Labeling11.0XML13,157ActiveNadia Petrova
CC-7721.7.9Prescribing Information9.2HTML4,363BlockedDmitri Volkov
CC-8721.7.2Cover Letter1.8XML9,852SubmittedLieselotte van der Berg
CC-9721.7.1Prescribing Information12.1Word4,828FailedDmitri Volkov
CC-10723.4.4Manufacturing Process6.1PDF14,489OverdueDmitri Volkov
CC-11721.2.7Prescribing Information9.1Word14,913PendingCarlos Mendez
CC-12721.2.7Prescribing Information12.7XML13,784ApprovedPriya Sharma
CC-13725.5.8Integrated Summary of Safety7.7PDF8,436FailedLieselotte van der Berg
CC-14723.3.4Drug Substance9.2XML578FailedPriya Sharma
CC-15723.6.4Analytical Methods8.8XML3,358BlockedNadia Petrova
CC-16721.6.9Proposed Conditions of Approval5.8PDF1,210DraftDmitri Volkov
CC-17722.5.6Quality Overall Summary1.5XML9,978ApprovedPriya Sharma
CC-18724.1.7Pharmacokinetics Studies11.6XML11,492DraftJames O'Brien
CC-19724.4.7Carcinogenicity10.0PDF2,598ApprovedTomoko Ikeda