Dossier DOS-004

Dossier in eCTD format, version 1.3.0, for application NMPA-2021-0004. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-004
Format
eCTD
Version
1.3.0
Status
Draft
Application
NMPA-2021-0004
Created
2022-04-28
Updated
2024-04-05
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information8Active
2CTD Summaries3In Progress
3Quality13Draft
4Nonclinical Study Reports15Overdue
5Clinical Study Reports10Draft
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0043.6.1Stability Data8.4XML11,598ApprovedPriya Sharma
CC-1044.1.8Pharmacology Studies7.2PDF7,037In ProgressSarah Chen
CC-2044.6.4Pharmacokinetics Studies11.4PDF14,113ApprovedDmitri Volkov
CC-3041.9.3Cover Letter1.2XML4,653ApprovedTomoko Ikeda
CC-4042.9.1Nonclinical Overview3.7XML4,502ActiveLieselotte van der Berg
CC-5043.9.2Drug Product9.1PDF8,771SubmittedLieselotte van der Berg
CC-6042.7.2Clinical Summary4.8PDF1,537CompletedDmitri Volkov
CC-7042.4.7Nonclinical Overview8.5PDF4,123DraftSarah Chen
CC-8041.7.2Cover Letter9.1PDF6,685DraftMarcus Webb
CC-9043.6.7Manufacturing Process1.6XML6,516ApprovedSarah Chen
CC-10043.5.4Container Closure System7.2XML8,696PendingPriya Sharma
CC-11045.1.7Study Reports – Safety2.6PDF579BlockedPriya Sharma
CC-12043.1.6Drug Product5.9PDF2,975CompletedCarlos Mendez
CC-13044.8.7Toxicology Studies10.3PDF3,141PendingSarah Chen
CC-14042.5.8Nonclinical Summary6.5HTML2,494DraftAisha Okonkwo
CC-15044.6.1Carcinogenicity9.2HTML13,932SubmittedMarcus Webb
CC-16041.3.3Cover Letter9.2HTML11,294In ProgressNadia Petrova
CC-17043.5.8Appendices5.8HTML855ActivePriya Sharma
CC-18044.2.4Pharmacokinetics Studies5.0XML9,897BlockedJames O'Brien
CC-19045.9.8Integrated Summary of Efficacy4.9Word5,061OverdueCarlos Mendez