Dossier DOS-064

Dossier in eCTD format, version 3.8.1, for application NMPA-2021-0064. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-064
Format
eCTD
Version
3.8.1
Status
Approved
Application
NMPA-2021-0064
Created
2022-05-04
Updated
2023-11-13
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information8Draft
2CTD Summaries13Overdue
3Quality14Approved
4Nonclinical Study Reports13Pending
5Clinical Study Reports15Overdue
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0644.8.9Toxicology Studies5.7XML2,928CompletedPriya Sharma
CC-1641.7.2Patient Labeling1.9PDF2,437FailedPriya Sharma
CC-2642.9.2Quality Overall Summary5.7PDF2,869DraftJames O'Brien
CC-3642.1.1Nonclinical Summary12.6XML3,617CompletedPriya Sharma
CC-4642.3.1Nonclinical Overview11.9Word12,983ActiveAisha Okonkwo
CC-5641.3.6Proposed Conditions of Approval1.2PDF2,656ApprovedNadia Petrova
CC-6644.8.6Toxicology Studies3.2HTML2,307ActivePriya Sharma
CC-7644.7.3Pharmacokinetics Studies5.0XML5,434CompletedDmitri Volkov
CC-8645.8.7Study Reports – Efficacy4.8PDF4,168ActiveNadia Petrova
CC-9642.7.8Nonclinical Overview1.1XML3,158ApprovedPriya Sharma
CC-10643.7.4Manufacturing Process4.1PDF8,133PendingAisha Okonkwo
CC-11645.3.9Study Reports – Clinical Pharmacology1.3HTML2,808CompletedAisha Okonkwo
CC-12645.4.2Study Reports – Clinical Pharmacology10.2PDF6,071In ProgressCarlos Mendez
CC-13644.9.7Pharmacology Studies3.9HTML10,717PendingDmitri Volkov
CC-14644.2.4Carcinogenicity1.9PDF1,747PendingDmitri Volkov
CC-15642.9.1Quality Overall Summary11.6XML1,334ApprovedAisha Okonkwo
CC-16644.7.4Genotoxicity8.1Word7,421OverdueAisha Okonkwo
CC-17644.1.2Carcinogenicity9.6HTML5,094BlockedTomoko Ikeda
CC-18642.3.9Nonclinical Summary5.5XML10,052FailedLieselotte van der Berg
CC-19643.6.9Drug Substance3.9HTML4,579SubmittedNadia Petrova