Dossier DOS-063

Dossier in NeeS format, version 8.3.7, for application PMDA-2022-0063. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-063
Format
NeeS
Version
8.3.7
Status
Submitted
Application
PMDA-2022-0063
Created
2022-10-15
Updated
2023-02-11
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information14Completed
2CTD Summaries5Failed
3Quality10Approved
4Nonclinical Study Reports12In Progress
5Clinical Study Reports12Draft
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0634.6.3Toxicology Studies11.0XML965FailedLieselotte van der Berg
CC-1631.4.5Cover Letter10.7XML4,695OverdueMarcus Webb
CC-2631.3.2Prescribing Information10.3HTML3,647PendingSarah Chen
CC-3634.4.4Pharmacokinetics Studies11.0Word7,126ActivePriya Sharma
CC-4635.7.5Integrated Summary of Efficacy10.0PDF14,392BlockedCarlos Mendez
CC-5634.3.5Pharmacokinetics Studies7.0HTML7,309In ProgressAisha Okonkwo
CC-6631.2.9Application Form3.9PDF1,313In ProgressCarlos Mendez
CC-7631.4.9Prescribing Information6.2XML10,620PendingDmitri Volkov
CC-8633.2.5Drug Substance6.3PDF11,731PendingTomoko Ikeda
CC-9631.1.5Cover Letter4.6XML4,736FailedNadia Petrova
CC-10631.2.1Application Form12.4PDF9,249SubmittedTomoko Ikeda
CC-11634.2.3Genotoxicity10.0PDF13,015BlockedCarlos Mendez
CC-12633.6.5Drug Product4.4HTML8,944SubmittedDmitri Volkov
CC-13632.6.1Clinical Summary7.4XML14,804ActiveDmitri Volkov
CC-14634.6.1Carcinogenicity12.9Word9,177DraftSarah Chen
CC-15635.7.6Study Reports – Safety11.8PDF12,338ApprovedSarah Chen
CC-16632.8.5Quality Overall Summary3.4XML7,444CompletedAisha Okonkwo
CC-17632.9.2Clinical Summary7.8PDF4,304FailedSarah Chen
CC-18631.7.7Proposed Conditions of Approval7.2XML13,792SubmittedLieselotte van der Berg
CC-19633.7.9Stability Data8.3PDF10,031BlockedMarcus Webb