Dossier DOS-033

Dossier in CTD format, version 4.5.8, for application CDSCO-2022-0033. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-033
Format
CTD
Version
4.5.8
Status
Submitted
Application
CDSCO-2022-0033
Created
2022-07-13
Updated
2024-04-16
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information3Draft
2CTD Summaries11In Progress
3Quality10Submitted
4Nonclinical Study Reports6Blocked
5Clinical Study Reports4Approved
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0332.2.2Clinical Summary1.0XML5,926BlockedPriya Sharma
CC-1331.8.7Application Form3.8XML5,911PendingJames O'Brien
CC-2335.7.1Study Reports – Efficacy9.0XML11,137BlockedCarlos Mendez
CC-3333.5.8Stability Data3.1Word3,474BlockedDmitri Volkov
CC-4334.5.7Genotoxicity2.9PDF11,928ApprovedMarcus Webb
CC-5334.5.4Toxicology Studies9.8HTML1,583ApprovedJames O'Brien
CC-6331.4.5Patient Labeling2.8HTML11,765BlockedAisha Okonkwo
CC-7331.7.7Cover Letter5.4XML14,322PendingJames O'Brien
CC-8331.8.8Patient Labeling11.4Word5,245ApprovedTomoko Ikeda
CC-9332.8.2Quality Overall Summary12.3Word9,937DraftSarah Chen
CC-10333.5.1Manufacturing Process3.8HTML4,187PendingTomoko Ikeda
CC-11333.3.9Drug Product6.0HTML4,601ApprovedNadia Petrova
CC-12331.3.7Prescribing Information8.3XML1,967OverdueMarcus Webb
CC-13335.6.2Study Reports – Safety2.8XML12,466BlockedDmitri Volkov
CC-14332.7.1Nonclinical Summary8.4HTML9,098PendingLieselotte van der Berg
CC-15335.1.2Integrated Summary of Efficacy7.3PDF14,640PendingTomoko Ikeda
CC-16335.7.4Integrated Summary of Safety7.7XML13,292OverdueMarcus Webb
CC-17332.3.8Nonclinical Overview6.3HTML10,151In ProgressNadia Petrova
CC-18332.8.2Nonclinical Overview2.6HTML2,635CompletedTomoko Ikeda
CC-19334.8.8Carcinogenicity10.3XML10,762ActiveAisha Okonkwo