Dossier DOS-035

Dossier in eCTD format, version 8.6.9, for application ANMAT-2020-0035. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-035
Format
eCTD
Version
8.6.9
Status
Submitted
Application
ANMAT-2020-0035
Created
2023-01-19
Updated
2024-04-17
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information8In Progress
2CTD Summaries13Completed
3Quality15Active
4Nonclinical Study Reports4Draft
5Clinical Study Reports9Blocked
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0354.6.3Pharmacokinetics Studies4.3HTML6,927OverdueNadia Petrova
CC-1355.5.9Study Reports – Efficacy1.1PDF2,856DraftLieselotte van der Berg
CC-2351.8.4Patient Labeling2.5XML4,192CompletedTomoko Ikeda
CC-3352.3.4Quality Overall Summary2.3HTML9,894DraftMarcus Webb
CC-4353.1.3Appendices9.5PDF877OverdueAisha Okonkwo
CC-5355.1.9Study Reports – Clinical Pharmacology5.4PDF14,237FailedSarah Chen
CC-6351.1.4Application Form9.1Word6,476DraftAisha Okonkwo
CC-7351.8.7Patient Labeling1.8PDF5,529BlockedJames O'Brien
CC-8351.4.9Cover Letter12.1Word8,983OverdueLieselotte van der Berg
CC-9352.7.1Clinical Overview1.7XML4,342DraftCarlos Mendez
CC-10352.2.4Nonclinical Overview4.2XML13,245ApprovedNadia Petrova
CC-11355.3.9Integrated Summary of Safety1.7HTML13,180CompletedLieselotte van der Berg
CC-12355.9.7Integrated Summary of Efficacy7.3XML4,508OverdueLieselotte van der Berg
CC-13351.8.5Application Form8.0Word2,209SubmittedMarcus Webb
CC-14353.7.1Drug Substance2.8XML6,685BlockedNadia Petrova
CC-15352.8.4Nonclinical Overview9.2Word2,348OverdueLieselotte van der Berg
CC-16351.7.3Proposed Conditions of Approval9.2HTML5,856In ProgressTomoko Ikeda
CC-17351.3.7Application Form12.5XML7,806In ProgressLieselotte van der Berg
CC-18354.8.4Pharmacology Studies1.8XML7,217FailedPriya Sharma
CC-19354.9.6Pharmacokinetics Studies10.8XML10,284ApprovedSarah Chen