Dossier DOS-053

Dossier in CTD format, version 4.6.7, for application CDSCO-2022-0053. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-053
Format
CTD
Version
4.6.7
Status
Completed
Application
CDSCO-2022-0053
Created
2022-05-12
Updated
2023-08-10
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information7Pending
2CTD Summaries12Approved
3Quality6Completed
4Nonclinical Study Reports13Completed
5Clinical Study Reports7Completed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0534.4.2Genotoxicity8.6PDF12,321SubmittedCarlos Mendez
CC-1535.7.5Study Reports – Clinical Pharmacology9.4PDF4,969OverdueNadia Petrova
CC-2533.1.9Stability Data7.3XML3,529In ProgressJames O'Brien
CC-3535.2.9Integrated Summary of Efficacy6.4HTML9,085BlockedNadia Petrova
CC-4531.3.4Cover Letter4.8HTML7,873In ProgressCarlos Mendez
CC-5532.9.2Nonclinical Summary1.1HTML2,373DraftDmitri Volkov
CC-6532.2.2Clinical Summary7.3PDF907ApprovedSarah Chen
CC-7533.1.6Container Closure System7.2XML10,739ApprovedNadia Petrova
CC-8533.7.8Stability Data2.3XML7,764In ProgressPriya Sharma
CC-9534.6.5Pharmacokinetics Studies10.3HTML12,343DraftDmitri Volkov
CC-10533.4.1Analytical Methods11.8PDF12,772BlockedPriya Sharma
CC-11531.6.3Cover Letter7.4Word10,410SubmittedSarah Chen
CC-12531.5.6Proposed Conditions of Approval8.0XML7,567CompletedPriya Sharma
CC-13534.6.3Pharmacokinetics Studies12.9Word11,507In ProgressNadia Petrova
CC-14534.3.6Pharmacokinetics Studies1.5PDF13,117In ProgressJames O'Brien
CC-15533.5.8Manufacturing Process6.6XML14,672FailedPriya Sharma
CC-16533.2.1Container Closure System7.9PDF8,458BlockedPriya Sharma
CC-17533.5.4Analytical Methods8.0XML6,264DraftDmitri Volkov
CC-18535.3.1Integrated Summary of Safety9.3PDF2,726DraftDmitri Volkov
CC-19533.1.5Analytical Methods11.8PDF11,039PendingJames O'Brien