Dossier DOS-055

Dossier in eCTD format, version 8.2.0, for application ANMAT-2020-0055. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-055
Format
eCTD
Version
8.2.0
Status
Draft
Application
ANMAT-2020-0055
Created
2023-01-23
Updated
2023-07-02
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information5Active
2CTD Summaries8Pending
3Quality14Blocked
4Nonclinical Study Reports7Draft
5Clinical Study Reports15In Progress
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0552.4.5Quality Overall Summary5.2PDF6,927DraftNadia Petrova
CC-1553.7.2Stability Data5.5XML1,843OverdueMarcus Webb
CC-2554.5.5Pharmacokinetics Studies11.1Word8,243DraftMarcus Webb
CC-3554.1.5Pharmacology Studies9.5Word14,985ApprovedPriya Sharma
CC-4551.7.9Application Form6.0HTML7,722FailedTomoko Ikeda
CC-5554.1.6Pharmacology Studies1.1HTML12,986CompletedNadia Petrova
CC-6555.6.8Integrated Summary of Safety8.3Word3,030SubmittedAisha Okonkwo
CC-7553.9.5Container Closure System6.9Word10,946DraftPriya Sharma
CC-8552.2.9Nonclinical Summary2.0Word10,934PendingCarlos Mendez
CC-9553.9.3Stability Data2.8HTML998CompletedJames O'Brien
CC-10553.2.3Drug Product11.4PDF1,823FailedPriya Sharma
CC-11554.5.1Pharmacology Studies7.2Word10,000DraftNadia Petrova
CC-12554.5.3Pharmacology Studies1.2Word3,501PendingPriya Sharma
CC-13552.1.8Quality Overall Summary9.6PDF13,256In ProgressPriya Sharma
CC-14555.7.8Integrated Summary of Efficacy8.2XML8,747DraftTomoko Ikeda
CC-15551.1.5Prescribing Information4.7XML10,964FailedLieselotte van der Berg
CC-16551.9.7Application Form11.3XML13,095In ProgressTomoko Ikeda
CC-17555.3.6Integrated Summary of Safety7.0HTML2,134ApprovedAisha Okonkwo
CC-18555.8.3Study Reports – Clinical Pharmacology9.9PDF7,640BlockedTomoko Ikeda
CC-19555.2.1Study Reports – Clinical Pharmacology9.5Word9,888DraftSarah Chen