Dossier DOS-032

Dossier in NeeS format, version 4.2.7, for application HSA-2023-0032. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-032
Format
NeeS
Version
4.2.7
Status
In Progress
Application
HSA-2023-0032
Created
2022-09-07
Updated
2024-04-06
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information14Overdue
2CTD Summaries5Approved
3Quality13Submitted
4Nonclinical Study Reports11Approved
5Clinical Study Reports15Failed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0325.9.4Study Reports – Safety7.1PDF11,561OverduePriya Sharma
CC-1325.7.1Study Reports – Efficacy10.8Word1,754OverdueSarah Chen
CC-2323.8.3Container Closure System11.5Word9,151PendingLieselotte van der Berg
CC-3325.2.5Study Reports – Efficacy7.6HTML6,334ApprovedNadia Petrova
CC-4324.9.8Toxicology Studies8.8PDF11,901OverdueAisha Okonkwo
CC-5322.4.8Nonclinical Overview10.2Word14,993DraftJames O'Brien
CC-6322.2.4Clinical Overview5.5XML6,245OverdueJames O'Brien
CC-7323.6.2Stability Data11.9HTML6,911DraftMarcus Webb
CC-8324.6.3Toxicology Studies3.3Word2,374PendingDmitri Volkov
CC-9321.6.7Patient Labeling6.1PDF10,331OverdueTomoko Ikeda
CC-10321.1.5Application Form11.1PDF2,935PendingSarah Chen
CC-11322.4.3Clinical Overview2.9Word1,543DraftTomoko Ikeda
CC-12324.3.4Pharmacology Studies1.0XML10,645ActiveMarcus Webb
CC-13323.9.6Container Closure System1.3HTML9,841DraftAisha Okonkwo
CC-14323.9.5Analytical Methods6.9Word4,562ApprovedTomoko Ikeda
CC-15322.5.7Quality Overall Summary6.0XML8,522FailedDmitri Volkov
CC-16323.7.3Drug Substance8.9HTML6,752DraftPriya Sharma
CC-17321.6.1Proposed Conditions of Approval8.5HTML13,325FailedAisha Okonkwo
CC-18325.5.7Integrated Summary of Safety9.2Word14,759BlockedAisha Okonkwo
CC-19322.6.3Quality Overall Summary12.1HTML1,313PendingCarlos Mendez