Dossier DOS-054

Dossier in eCTD format, version 8.5.4, for application COFEPRIS-2021-0054. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-054
Format
eCTD
Version
8.5.4
Status
Draft
Application
COFEPRIS-2021-0054
Created
2023-01-10
Updated
2024-05-19
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information3Blocked
2CTD Summaries7Draft
3Quality12Overdue
4Nonclinical Study Reports5Draft
5Clinical Study Reports12Draft
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0544.2.7Pharmacokinetics Studies5.2XML14,070OverdueTomoko Ikeda
CC-1543.3.1Container Closure System6.3HTML5,300SubmittedMarcus Webb
CC-2545.1.6Study Reports – Efficacy12.5Word4,710OverdueJames O'Brien
CC-3541.3.7Proposed Conditions of Approval6.9XML13,548DraftJames O'Brien
CC-4544.1.8Carcinogenicity6.9PDF9,490ApprovedCarlos Mendez
CC-5542.3.7Quality Overall Summary6.2HTML10,868DraftAisha Okonkwo
CC-6544.8.9Toxicology Studies11.6HTML14,933FailedSarah Chen
CC-7544.7.7Carcinogenicity12.3HTML968CompletedPriya Sharma
CC-8543.1.8Appendices2.7HTML12,350ActiveTomoko Ikeda
CC-9544.6.6Pharmacology Studies3.3XML1,773FailedAisha Okonkwo
CC-10543.7.6Appendices5.8PDF2,517In ProgressCarlos Mendez
CC-11544.3.8Pharmacokinetics Studies4.7HTML7,594ActiveLieselotte van der Berg
CC-12542.8.8Nonclinical Overview10.5Word11,363ApprovedAisha Okonkwo
CC-13542.9.6Nonclinical Summary12.1XML14,654FailedSarah Chen
CC-14543.6.3Drug Product12.7Word11,914OverdueSarah Chen
CC-15543.9.7Drug Product6.2PDF6,239CompletedCarlos Mendez
CC-16544.4.4Pharmacology Studies5.7PDF2,036In ProgressNadia Petrova
CC-17541.3.9Proposed Conditions of Approval2.8Word11,706DraftPriya Sharma
CC-18542.4.7Nonclinical Overview3.6PDF8,810DraftLieselotte van der Berg
CC-19541.9.5Proposed Conditions of Approval12.7HTML6,594OverduePriya Sharma