Dossier DOS-068

Dossier in eCTD format, version 8.6.8, for application MHRA-2022-0068. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-068
Format
eCTD
Version
8.6.8
Status
In Progress
Application
MHRA-2022-0068
Created
2022-03-10
Updated
2023-10-14
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information10Pending
2CTD Summaries12Draft
3Quality10Overdue
4Nonclinical Study Reports6In Progress
5Clinical Study Reports5Completed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0684.6.6Pharmacology Studies6.8Word5,253SubmittedMarcus Webb
CC-1684.8.9Toxicology Studies8.7Word10,134PendingNadia Petrova
CC-2683.8.4Stability Data7.7PDF8,474ActiveDmitri Volkov
CC-3682.6.7Nonclinical Summary8.4XML1,583ActiveCarlos Mendez
CC-4681.2.5Prescribing Information2.4Word4,276DraftMarcus Webb
CC-5685.1.4Study Reports – Clinical Pharmacology3.6Word9,626BlockedNadia Petrova
CC-6681.8.6Patient Labeling6.5PDF2,244PendingCarlos Mendez
CC-7683.1.6Drug Product8.7HTML8,416In ProgressSarah Chen
CC-8685.6.8Study Reports – Safety7.6XML11,927In ProgressJames O'Brien
CC-9685.3.7Integrated Summary of Efficacy8.3HTML9,908CompletedLieselotte van der Berg
CC-10681.7.8Patient Labeling9.0XML13,099ApprovedDmitri Volkov
CC-11682.9.8Quality Overall Summary6.0XML4,678BlockedDmitri Volkov
CC-12684.1.1Pharmacokinetics Studies5.9Word7,815ApprovedJames O'Brien
CC-13684.2.7Pharmacology Studies11.9PDF6,165DraftLieselotte van der Berg
CC-14681.7.4Application Form9.1Word7,524ApprovedLieselotte van der Berg
CC-15683.1.5Drug Product8.8XML7,180OverdueSarah Chen
CC-16682.6.8Clinical Overview8.5XML1,670SubmittedJames O'Brien
CC-17683.1.6Manufacturing Process2.3XML8,544FailedDmitri Volkov
CC-18684.2.9Toxicology Studies11.7Word12,583OverdueCarlos Mendez
CC-19683.1.5Appendices4.3HTML10,006ApprovedLieselotte van der Berg