Dossier DOS-037

Dossier in NeeS format, version 5.2.8, for application SFDA-2023-0037. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-037
Format
NeeS
Version
5.2.8
Status
Overdue
Application
SFDA-2023-0037
Created
2022-08-28
Updated
2023-12-09
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information12In Progress
2CTD Summaries12Blocked
3Quality10Blocked
4Nonclinical Study Reports11In Progress
5Clinical Study Reports8Approved
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0372.1.7Clinical Summary10.6XML12,998ActiveDmitri Volkov
CC-1374.4.7Pharmacokinetics Studies10.7HTML14,320In ProgressTomoko Ikeda
CC-2371.6.7Application Form9.5HTML6,376FailedCarlos Mendez
CC-3371.2.9Application Form1.8Word11,475PendingNadia Petrova
CC-4372.9.5Nonclinical Overview12.9PDF7,879PendingTomoko Ikeda
CC-5373.3.1Appendices3.0Word8,918CompletedJames O'Brien
CC-6375.4.2Integrated Summary of Efficacy1.9HTML501FailedMarcus Webb
CC-7374.7.2Toxicology Studies9.1XML13,485BlockedTomoko Ikeda
CC-8373.5.8Analytical Methods6.6PDF9,521CompletedJames O'Brien
CC-9374.3.7Pharmacology Studies5.7PDF13,530OverdueDmitri Volkov
CC-10373.9.5Drug Substance8.7Word14,513CompletedSarah Chen
CC-11373.3.7Manufacturing Process2.9PDF12,899BlockedSarah Chen
CC-12371.9.3Cover Letter9.0HTML14,320BlockedMarcus Webb
CC-13374.3.6Pharmacokinetics Studies10.9Word10,503ApprovedLieselotte van der Berg
CC-14374.3.6Genotoxicity4.4PDF10,866SubmittedAisha Okonkwo
CC-15374.1.1Pharmacokinetics Studies2.1XML13,902BlockedPriya Sharma
CC-16375.4.1Study Reports – Efficacy6.0XML4,237OverdueCarlos Mendez
CC-17373.6.7Analytical Methods3.1PDF6,264CompletedSarah Chen
CC-18375.8.4Study Reports – Efficacy4.2PDF7,362In ProgressCarlos Mendez
CC-19372.9.6Nonclinical Overview9.0PDF6,267OverdueJames O'Brien