Dossier DOS-095

Dossier in CTD format, version 3.3.3, for application ANMAT-2020-0095. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-095
Format
CTD
Version
3.3.3
Status
Blocked
Application
ANMAT-2020-0095
Created
2022-11-09
Updated
2023-12-21
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information8In Progress
2CTD Summaries5Completed
3Quality10Submitted
4Nonclinical Study Reports13In Progress
5Clinical Study Reports4Active
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0954.5.8Toxicology Studies2.4Word6,675BlockedDmitri Volkov
CC-1953.3.9Analytical Methods8.8XML6,752FailedJames O'Brien
CC-2951.2.1Patient Labeling7.9PDF9,155OverdueNadia Petrova
CC-3952.9.2Quality Overall Summary6.1HTML3,039DraftMarcus Webb
CC-4955.9.9Study Reports – Efficacy12.4PDF7,662SubmittedMarcus Webb
CC-5951.2.3Application Form1.0PDF14,579ApprovedTomoko Ikeda
CC-6951.1.1Patient Labeling7.8XML2,373FailedSarah Chen
CC-7953.6.6Manufacturing Process2.7XML2,946SubmittedJames O'Brien
CC-8952.9.4Nonclinical Summary12.7HTML7,579OverduePriya Sharma
CC-9952.9.9Clinical Overview7.5XML13,445ActiveLieselotte van der Berg
CC-10955.6.2Study Reports – Clinical Pharmacology12.8Word6,654FailedPriya Sharma
CC-11955.2.7Study Reports – Clinical Pharmacology4.1XML7,969CompletedDmitri Volkov
CC-12955.3.5Integrated Summary of Efficacy3.8HTML9,032OverduePriya Sharma
CC-13954.5.5Pharmacokinetics Studies10.8XML7,260CompletedPriya Sharma
CC-14955.3.6Integrated Summary of Safety2.5Word9,831ApprovedPriya Sharma
CC-15955.1.7Study Reports – Safety8.7PDF10,695OverdueTomoko Ikeda
CC-16955.8.5Integrated Summary of Efficacy2.0PDF11,526FailedMarcus Webb
CC-17951.5.2Prescribing Information4.0HTML4,685PendingJames O'Brien
CC-18952.3.7Clinical Overview5.7HTML6,941BlockedPriya Sharma
CC-19952.4.1Clinical Overview5.8PDF1,827BlockedNadia Petrova