Dossier DOS-001

Dossier in NeeS format, version 6.3.6, for application FDA-2024-0001. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-001
Format
NeeS
Version
6.3.6
Status
Submitted
Application
FDA-2024-0001
Created
2022-08-19
Updated
2023-02-22
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information13Draft
2CTD Summaries7Failed
3Quality7Active
4Nonclinical Study Reports4Completed
5Clinical Study Reports14Pending
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0014.9.1Pharmacology Studies8.2HTML896BlockedTomoko Ikeda
CC-1013.4.6Analytical Methods4.6Word14,351DraftCarlos Mendez
CC-2014.9.5Pharmacokinetics Studies10.6PDF9,541PendingDmitri Volkov
CC-3015.3.3Study Reports – Safety10.0PDF11,747DraftLieselotte van der Berg
CC-4013.7.8Drug Product8.3PDF1,437BlockedMarcus Webb
CC-5013.6.3Appendices5.8Word4,047CompletedDmitri Volkov
CC-6014.5.2Pharmacology Studies1.6PDF14,540In ProgressSarah Chen
CC-7014.7.2Toxicology Studies8.8PDF6,892BlockedMarcus Webb
CC-8012.2.8Nonclinical Summary6.1XML8,705ActiveCarlos Mendez
CC-9012.3.2Nonclinical Summary1.6Word11,382ApprovedPriya Sharma
CC-10015.2.9Study Reports – Efficacy9.1HTML5,789BlockedPriya Sharma
CC-11014.4.3Carcinogenicity10.0PDF14,989SubmittedTomoko Ikeda
CC-12015.3.7Study Reports – Clinical Pharmacology10.2HTML9,317ApprovedTomoko Ikeda
CC-13015.2.4Integrated Summary of Safety5.0Word10,258CompletedDmitri Volkov
CC-14012.6.4Nonclinical Summary4.0HTML8,732SubmittedDmitri Volkov
CC-15013.4.1Drug Product12.1Word12,937BlockedAisha Okonkwo
CC-16013.9.2Appendices8.6HTML5,591DraftPriya Sharma
CC-17014.9.1Pharmacokinetics Studies2.7PDF2,113ActiveTomoko Ikeda
CC-18011.9.4Proposed Conditions of Approval11.8HTML6,165DraftCarlos Mendez
CC-19011.7.6Cover Letter9.7PDF3,375PendingNadia Petrova