Dossier DOS-075

Dossier in CTD format, version 3.5.3, for application ANMAT-2020-0075. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-075
Format
CTD
Version
3.5.3
Status
Failed
Application
ANMAT-2020-0075
Created
2022-10-17
Updated
2023-08-20
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information15Completed
2CTD Summaries14Completed
3Quality9Pending
4Nonclinical Study Reports15Active
5Clinical Study Reports8Pending
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0753.7.7Container Closure System7.9PDF14,040SubmittedTomoko Ikeda
CC-1754.5.1Carcinogenicity8.7Word12,454OverdueNadia Petrova
CC-2753.3.4Stability Data10.4Word12,828ApprovedPriya Sharma
CC-3752.4.1Nonclinical Overview9.2PDF10,850OverdueLieselotte van der Berg
CC-4752.5.2Nonclinical Overview1.5Word10,955OverdueAisha Okonkwo
CC-5751.8.1Cover Letter8.8XML3,652OverdueAisha Okonkwo
CC-6752.7.6Nonclinical Summary7.0XML4,950OverdueJames O'Brien
CC-7753.7.5Analytical Methods7.0PDF13,795In ProgressSarah Chen
CC-8755.7.2Integrated Summary of Efficacy3.6XML4,599ApprovedJames O'Brien
CC-9752.7.4Nonclinical Summary12.6HTML11,168CompletedCarlos Mendez
CC-10752.3.1Clinical Summary2.3XML9,231SubmittedJames O'Brien
CC-11751.8.9Patient Labeling3.5PDF10,205ActiveJames O'Brien
CC-12752.8.5Quality Overall Summary2.4PDF6,610In ProgressSarah Chen
CC-13753.4.4Drug Product8.3XML2,601ApprovedCarlos Mendez
CC-14751.3.9Cover Letter1.7HTML10,646PendingAisha Okonkwo
CC-15753.8.4Container Closure System2.1Word13,636ApprovedDmitri Volkov
CC-16754.4.3Genotoxicity8.8Word12,570ApprovedDmitri Volkov
CC-17752.2.8Clinical Summary2.6XML13,128CompletedCarlos Mendez
CC-18752.8.4Quality Overall Summary10.2HTML6,569CompletedSarah Chen
CC-19753.8.2Stability Data10.3HTML9,839DraftNadia Petrova