Dossier DOS-014

Dossier in eCTD format, version 6.0.9, for application COFEPRIS-2021-0014. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-014
Format
eCTD
Version
6.0.9
Status
Blocked
Application
COFEPRIS-2021-0014
Created
2022-06-30
Updated
2023-10-26
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information12Submitted
2CTD Summaries5Failed
3Quality4Approved
4Nonclinical Study Reports6Draft
5Clinical Study Reports11Approved
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0142.1.5Nonclinical Overview9.2HTML5,026DraftMarcus Webb
CC-1143.1.9Drug Substance2.4XML10,737PendingJames O'Brien
CC-2142.5.8Quality Overall Summary8.0XML13,111In ProgressMarcus Webb
CC-3145.5.8Study Reports – Efficacy6.1PDF11,547ApprovedAisha Okonkwo
CC-4141.8.1Patient Labeling1.4Word5,933PendingSarah Chen
CC-5145.9.6Study Reports – Clinical Pharmacology2.7PDF4,111OverdueDmitri Volkov
CC-6143.8.8Appendices6.7XML14,913ApprovedTomoko Ikeda
CC-7143.4.7Manufacturing Process3.7PDF12,998BlockedPriya Sharma
CC-8142.7.3Nonclinical Overview12.2XML1,735OverdueTomoko Ikeda
CC-9141.9.7Proposed Conditions of Approval1.0HTML1,521ApprovedLieselotte van der Berg
CC-10141.2.4Cover Letter12.4Word6,662SubmittedJames O'Brien
CC-11145.2.3Study Reports – Efficacy3.6Word7,017OverdueCarlos Mendez
CC-12144.8.6Carcinogenicity5.8Word2,952DraftAisha Okonkwo
CC-13144.2.4Carcinogenicity1.5PDF1,180PendingNadia Petrova
CC-14142.2.3Quality Overall Summary11.6HTML8,890CompletedDmitri Volkov
CC-15141.4.5Patient Labeling5.8HTML10,374CompletedNadia Petrova
CC-16141.9.6Application Form8.6PDF11,531ActiveLieselotte van der Berg
CC-17143.9.6Drug Substance1.7Word14,785ApprovedCarlos Mendez
CC-18143.5.4Container Closure System10.6XML849In ProgressMarcus Webb
CC-19145.4.5Study Reports – Efficacy8.9Word5,643OverdueAisha Okonkwo