Dossier DOS-057

Dossier in eCTD format, version 2.5.7, for application SFDA-2023-0057. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-057
Format
eCTD
Version
2.5.7
Status
Overdue
Application
SFDA-2023-0057
Created
2022-01-30
Updated
2023-10-02
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information8Active
2CTD Summaries15Blocked
3Quality12Completed
4Nonclinical Study Reports8Active
5Clinical Study Reports10Completed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0575.4.8Study Reports – Clinical Pharmacology4.4Word9,774DraftMarcus Webb
CC-1573.8.8Analytical Methods9.1XML9,488ApprovedJames O'Brien
CC-2574.6.7Carcinogenicity7.7PDF13,009BlockedCarlos Mendez
CC-3575.4.8Integrated Summary of Efficacy7.2XML12,286In ProgressJames O'Brien
CC-4572.2.5Quality Overall Summary7.6HTML5,288DraftAisha Okonkwo
CC-5572.4.7Clinical Overview4.2HTML9,388In ProgressTomoko Ikeda
CC-6571.4.4Application Form4.7PDF2,135DraftTomoko Ikeda
CC-7571.4.8Prescribing Information2.2HTML708SubmittedNadia Petrova
CC-8573.3.5Drug Substance6.1Word4,314In ProgressNadia Petrova
CC-9572.7.9Clinical Overview4.4PDF6,856OverdueAisha Okonkwo
CC-10574.6.9Pharmacokinetics Studies9.2XML12,442PendingLieselotte van der Berg
CC-11572.8.9Quality Overall Summary10.2XML4,280OverdueMarcus Webb
CC-12573.4.6Analytical Methods8.3HTML6,927CompletedNadia Petrova
CC-13574.3.6Pharmacology Studies10.8Word8,166FailedPriya Sharma
CC-14571.2.5Proposed Conditions of Approval6.5PDF13,031OverdueNadia Petrova
CC-15573.9.6Manufacturing Process4.8PDF738DraftJames O'Brien
CC-16573.7.3Analytical Methods8.3HTML11,325OverdueJames O'Brien
CC-17572.8.3Clinical Summary10.2HTML1,249PendingTomoko Ikeda
CC-18572.1.4Clinical Summary1.2PDF9,591DraftPriya Sharma
CC-19573.1.4Analytical Methods4.9PDF8,205ActiveLieselotte van der Berg