Dossier DOS-006
Dossier in eCTD format, version 8.0.6, for application HC-2024-0006. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-006
Format
eCTD
Version
8.0.6
Status
In Progress
Application
Created
2022-04-16
Updated
2024-03-08
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 4 | Failed |
| 2 | CTD Summaries | 11 | In Progress |
| 3 | Quality | 6 | Completed |
| 4 | Nonclinical Study Reports | 14 | In Progress |
| 5 | Clinical Study Reports | 15 | Active |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-006 | 3.5.3 | Stability Data | 4.8 | Word | 13,035 | Blocked | Tomoko Ikeda |
| CC-106 | 4.6.1 | Toxicology Studies | 7.0 | 956 | Submitted | Sarah Chen | |
| CC-206 | 4.2.6 | Toxicology Studies | 4.6 | HTML | 11,150 | Pending | Aisha Okonkwo |
| CC-306 | 4.4.2 | Genotoxicity | 4.9 | XML | 14,885 | Active | Sarah Chen |
| CC-406 | 4.1.2 | Carcinogenicity | 3.3 | 12,662 | In Progress | Priya Sharma | |
| CC-506 | 1.5.1 | Cover Letter | 3.4 | XML | 6,554 | Pending | Priya Sharma |
| CC-606 | 1.9.5 | Prescribing Information | 8.2 | XML | 4,177 | In Progress | Dmitri Volkov |
| CC-706 | 5.2.2 | Study Reports – Safety | 5.5 | XML | 10,221 | Approved | Tomoko Ikeda |
| CC-806 | 5.4.6 | Study Reports – Safety | 10.3 | Word | 6,453 | Draft | Aisha Okonkwo |
| CC-906 | 5.9.4 | Integrated Summary of Efficacy | 5.4 | 10,917 | Pending | Nadia Petrova | |
| CC-1006 | 1.1.1 | Application Form | 4.2 | Word | 3,059 | Overdue | Tomoko Ikeda |
| CC-1106 | 5.3.1 | Integrated Summary of Efficacy | 6.6 | XML | 1,438 | Approved | Carlos Mendez |
| CC-1206 | 3.6.7 | Manufacturing Process | 1.1 | XML | 10,983 | Active | Lieselotte van der Berg |
| CC-1306 | 2.9.1 | Clinical Overview | 4.4 | 3,913 | Failed | Carlos Mendez | |
| CC-1406 | 2.2.3 | Nonclinical Summary | 6.5 | Word | 12,911 | Submitted | Tomoko Ikeda |
| CC-1506 | 3.2.2 | Stability Data | 2.6 | 10,931 | Failed | Dmitri Volkov | |
| CC-1606 | 1.4.1 | Patient Labeling | 11.8 | Word | 14,480 | Draft | James O'Brien |
| CC-1706 | 2.4.9 | Clinical Overview | 12.7 | XML | 8,791 | Overdue | Lieselotte van der Berg |
| CC-1806 | 2.5.2 | Quality Overall Summary | 9.0 | HTML | 9,774 | Draft | Dmitri Volkov |
| CC-1906 | 2.8.4 | Clinical Summary | 2.7 | Word | 10,975 | Completed | Marcus Webb |
Showing 20 of 20 components