Dossier DOS-038

Dossier in eCTD format, version 6.3.3, for application SAHPRA-2022-0038. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-038
Format
eCTD
Version
6.3.3
Status
Draft
Application
SAHPRA-2022-0038
Created
2022-11-06
Updated
2023-07-30
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information7Active
2CTD Summaries8In Progress
3Quality4Active
4Nonclinical Study Reports15Pending
5Clinical Study Reports9Completed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0385.8.9Study Reports – Clinical Pharmacology4.2Word6,292FailedDmitri Volkov
CC-1383.4.4Drug Product3.8HTML3,023ActiveLieselotte van der Berg
CC-2385.7.4Integrated Summary of Efficacy5.6PDF10,853BlockedSarah Chen
CC-3385.3.9Integrated Summary of Efficacy7.0HTML6,180FailedLieselotte van der Berg
CC-4384.4.2Pharmacokinetics Studies6.6XML13,108In ProgressMarcus Webb
CC-5382.6.8Quality Overall Summary7.2XML2,586DraftDmitri Volkov
CC-6385.6.5Integrated Summary of Safety7.4PDF7,948ApprovedPriya Sharma
CC-7382.5.8Quality Overall Summary8.2XML2,777SubmittedDmitri Volkov
CC-8385.1.9Integrated Summary of Safety10.4HTML6,091DraftAisha Okonkwo
CC-9382.4.1Quality Overall Summary7.1Word7,489FailedPriya Sharma
CC-10383.8.9Stability Data2.8Word1,658PendingSarah Chen
CC-11381.1.1Patient Labeling6.6XML3,897OverduePriya Sharma
CC-12384.7.1Pharmacology Studies7.7HTML10,874In ProgressNadia Petrova
CC-13383.5.1Drug Product5.9Word7,380SubmittedLieselotte van der Berg
CC-14383.2.3Stability Data2.8HTML6,149ActiveAisha Okonkwo
CC-15382.1.7Quality Overall Summary3.2HTML7,350BlockedPriya Sharma
CC-16382.5.3Nonclinical Overview11.2XML11,125ApprovedLieselotte van der Berg
CC-17382.2.7Nonclinical Overview7.3PDF6,236In ProgressLieselotte van der Berg
CC-18381.3.9Proposed Conditions of Approval4.6XML8,799OverdueLieselotte van der Berg
CC-19383.5.2Drug Substance7.1HTML1,333In ProgressDmitri Volkov