Dossier DOS-083

Dossier in eCTD format, version 2.2.8, for application PMDA-2022-0083. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-083
Format
eCTD
Version
2.2.8
Status
Active
Application
PMDA-2022-0083
Created
2022-09-25
Updated
2024-01-18
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information5Overdue
2CTD Summaries8Failed
3Quality9Draft
4Nonclinical Study Reports12Overdue
5Clinical Study Reports7Draft
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0834.7.3Pharmacology Studies7.7PDF5,086OverdueMarcus Webb
CC-1835.2.3Study Reports – Efficacy1.6XML1,976ApprovedTomoko Ikeda
CC-2833.5.1Manufacturing Process6.8Word14,798OverdueCarlos Mendez
CC-3832.7.8Nonclinical Overview9.0HTML4,366In ProgressSarah Chen
CC-4835.6.5Study Reports – Safety1.3Word2,856DraftDmitri Volkov
CC-5833.9.4Container Closure System4.0PDF11,735In ProgressTomoko Ikeda
CC-6835.3.4Integrated Summary of Efficacy7.0HTML8,810ActiveCarlos Mendez
CC-7834.7.2Pharmacology Studies10.6Word6,372ActiveJames O'Brien
CC-8833.6.9Drug Substance2.7XML5,628PendingCarlos Mendez
CC-9833.4.5Drug Substance12.0Word5,263CompletedJames O'Brien
CC-10832.7.9Nonclinical Summary1.0HTML10,361BlockedJames O'Brien
CC-11831.9.3Patient Labeling2.6HTML6,766OverdueDmitri Volkov
CC-12834.3.4Pharmacokinetics Studies10.7XML12,419ActiveTomoko Ikeda
CC-13834.3.3Carcinogenicity5.8XML604SubmittedAisha Okonkwo
CC-14832.4.1Nonclinical Summary6.7PDF4,447SubmittedLieselotte van der Berg
CC-15835.7.9Integrated Summary of Efficacy1.2Word5,728FailedNadia Petrova
CC-16833.5.2Drug Product5.1XML9,855ApprovedNadia Petrova
CC-17834.5.2Pharmacology Studies10.1XML12,209BlockedJames O'Brien
CC-18832.9.7Clinical Summary6.5Word8,676PendingSarah Chen
CC-19831.1.9Cover Letter12.9XML1,215DraftDmitri Volkov