Dossier DOS-070

Dossier in eCTD format, version 1.8.3, for application MFDS-2020-0070. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-070
Format
eCTD
Version
1.8.3
Status
Active
Application
MFDS-2020-0070
Created
2022-01-18
Updated
2023-12-26
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information3Active
2CTD Summaries7Completed
3Quality5Failed
4Nonclinical Study Reports15Completed
5Clinical Study Reports13Approved
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0705.6.7Integrated Summary of Efficacy7.4HTML11,225PendingJames O'Brien
CC-1705.8.3Study Reports – Safety9.5Word14,849ApprovedPriya Sharma
CC-2702.9.3Nonclinical Overview11.0PDF8,226SubmittedPriya Sharma
CC-3705.3.7Study Reports – Clinical Pharmacology11.1PDF4,633BlockedSarah Chen
CC-4701.3.6Application Form1.1HTML589BlockedCarlos Mendez
CC-5703.2.9Appendices1.7Word10,297BlockedJames O'Brien
CC-6701.6.2Patient Labeling11.4HTML10,173FailedNadia Petrova
CC-7705.3.7Study Reports – Efficacy6.2PDF10,669ActiveSarah Chen
CC-8703.2.1Analytical Methods11.4XML10,561ActiveMarcus Webb
CC-9703.9.1Manufacturing Process10.3PDF13,722OverdueSarah Chen
CC-10702.3.1Quality Overall Summary10.5HTML8,801BlockedDmitri Volkov
CC-11703.5.5Analytical Methods8.7HTML2,799BlockedJames O'Brien
CC-12704.6.2Carcinogenicity5.6Word6,031DraftDmitri Volkov
CC-13704.1.7Toxicology Studies10.0PDF8,152PendingJames O'Brien
CC-14702.7.2Quality Overall Summary2.7HTML3,054OverduePriya Sharma
CC-15701.3.4Application Form12.7XML767CompletedJames O'Brien
CC-16702.9.3Clinical Summary11.5PDF12,801DraftPriya Sharma
CC-17703.5.6Manufacturing Process11.1Word14,510ApprovedTomoko Ikeda
CC-18705.1.6Integrated Summary of Efficacy9.8XML4,677In ProgressCarlos Mendez
CC-19705.4.4Study Reports – Safety5.7XML6,656PendingCarlos Mendez