Dossier DOS-026

Dossier in NeeS format, version 5.1.6, for application HC-2024-0026. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-026
Format
NeeS
Version
5.1.6
Status
Submitted
Application
HC-2024-0026
Created
2022-03-08
Updated
2024-04-10
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information11Overdue
2CTD Summaries10Submitted
3Quality11Draft
4Nonclinical Study Reports10Active
5Clinical Study Reports7Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0265.5.1Study Reports – Efficacy7.7PDF11,211CompletedSarah Chen
CC-1263.9.4Drug Substance2.3PDF11,875SubmittedPriya Sharma
CC-2262.8.1Nonclinical Overview11.5PDF3,884SubmittedTomoko Ikeda
CC-3261.3.4Patient Labeling5.8HTML9,971SubmittedJames O'Brien
CC-4265.3.3Study Reports – Efficacy11.8HTML2,719OverdueLieselotte van der Berg
CC-5264.1.1Carcinogenicity5.6XML8,120DraftSarah Chen
CC-6265.5.4Integrated Summary of Safety4.8HTML10,076SubmittedTomoko Ikeda
CC-7262.9.2Clinical Overview3.9Word10,869BlockedLieselotte van der Berg
CC-8265.5.1Integrated Summary of Safety12.5Word683ActiveSarah Chen
CC-9262.9.8Nonclinical Overview6.2XML7,695DraftAisha Okonkwo
CC-10261.8.3Cover Letter11.5PDF7,161DraftJames O'Brien
CC-11262.6.2Quality Overall Summary11.8Word11,872PendingMarcus Webb
CC-12263.8.5Manufacturing Process2.1XML1,004ApprovedSarah Chen
CC-13265.6.3Integrated Summary of Efficacy10.5HTML14,636SubmittedNadia Petrova
CC-14265.1.4Study Reports – Clinical Pharmacology12.1Word9,380OverdueSarah Chen
CC-15264.9.4Pharmacology Studies2.9PDF2,787ApprovedLieselotte van der Berg
CC-16261.6.2Prescribing Information6.4HTML7,105OverdueTomoko Ikeda
CC-17265.5.2Study Reports – Clinical Pharmacology1.5HTML12,984BlockedNadia Petrova
CC-18262.5.6Clinical Overview1.4PDF12,678SubmittedLieselotte van der Berg
CC-19263.5.4Drug Substance4.1PDF5,014ApprovedDmitri Volkov