Dossier DOS-044
Dossier in eCTD format, version 3.1.6, for application NMPA-2021-0044. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-044
Format
eCTD
Version
3.1.6
Status
Overdue
Application
Created
2023-01-04
Updated
2023-04-13
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 10 | Pending |
| 2 | CTD Summaries | 7 | Approved |
| 3 | Quality | 5 | Completed |
| 4 | Nonclinical Study Reports | 9 | Failed |
| 5 | Clinical Study Reports | 8 | Approved |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-044 | 3.5.4 | Manufacturing Process | 2.2 | HTML | 8,323 | Failed | Tomoko Ikeda |
| CC-144 | 2.5.9 | Clinical Summary | 4.9 | HTML | 6,739 | Active | Priya Sharma |
| CC-244 | 4.8.8 | Carcinogenicity | 1.1 | HTML | 13,437 | Failed | Marcus Webb |
| CC-344 | 1.6.6 | Prescribing Information | 3.4 | 12,441 | In Progress | Priya Sharma | |
| CC-444 | 5.1.9 | Integrated Summary of Safety | 5.2 | HTML | 13,169 | Failed | Lieselotte van der Berg |
| CC-544 | 3.4.1 | Stability Data | 10.8 | 6,038 | Failed | Dmitri Volkov | |
| CC-644 | 4.2.6 | Carcinogenicity | 6.1 | HTML | 10,801 | In Progress | Sarah Chen |
| CC-744 | 4.7.2 | Pharmacology Studies | 9.0 | HTML | 9,601 | Failed | James O'Brien |
| CC-844 | 5.9.6 | Study Reports – Safety | 8.7 | Word | 11,849 | Overdue | Tomoko Ikeda |
| CC-944 | 1.4.9 | Patient Labeling | 11.2 | HTML | 7,272 | Failed | Carlos Mendez |
| CC-1044 | 1.7.9 | Application Form | 11.1 | Word | 9,172 | Overdue | Lieselotte van der Berg |
| CC-1144 | 4.4.2 | Genotoxicity | 6.3 | 13,665 | Submitted | Dmitri Volkov | |
| CC-1244 | 3.4.7 | Container Closure System | 6.6 | HTML | 2,004 | Pending | Carlos Mendez |
| CC-1344 | 3.5.7 | Drug Substance | 3.3 | XML | 7,088 | Completed | Tomoko Ikeda |
| CC-1444 | 1.4.2 | Prescribing Information | 9.4 | 3,807 | Approved | Lieselotte van der Berg | |
| CC-1544 | 4.9.6 | Toxicology Studies | 3.4 | HTML | 12,163 | In Progress | Priya Sharma |
| CC-1644 | 5.8.9 | Study Reports – Efficacy | 1.5 | Word | 8,094 | Submitted | Marcus Webb |
| CC-1744 | 3.9.8 | Appendices | 6.2 | HTML | 12,694 | Approved | Sarah Chen |
| CC-1844 | 1.2.2 | Patient Labeling | 2.8 | XML | 3,588 | Active | Lieselotte van der Berg |
| CC-1944 | 2.8.6 | Quality Overall Summary | 10.3 | XML | 12,957 | Failed | Aisha Okonkwo |
Showing 20 of 20 components