Dossier DOS-093
Dossier in NeeS format, version 7.4.9, for application CDSCO-2022-0093. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-093
Format
NeeS
Version
7.4.9
Status
Submitted
Application
Created
2022-10-04
Updated
2023-11-16
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 10 | Blocked |
| 2 | CTD Summaries | 8 | Active |
| 3 | Quality | 11 | In Progress |
| 4 | Nonclinical Study Reports | 3 | Blocked |
| 5 | Clinical Study Reports | 11 | Approved |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-093 | 5.7.7 | Study Reports – Efficacy | 10.3 | HTML | 11,815 | Approved | Aisha Okonkwo |
| CC-193 | 5.2.3 | Study Reports – Safety | 9.6 | HTML | 5,801 | Active | Marcus Webb |
| CC-293 | 5.1.4 | Integrated Summary of Efficacy | 6.3 | Word | 6,768 | In Progress | Nadia Petrova |
| CC-393 | 1.5.9 | Prescribing Information | 5.5 | HTML | 9,057 | In Progress | Tomoko Ikeda |
| CC-493 | 2.8.4 | Quality Overall Summary | 4.4 | XML | 7,335 | In Progress | Dmitri Volkov |
| CC-593 | 5.3.8 | Integrated Summary of Efficacy | 6.5 | Word | 4,345 | Active | James O'Brien |
| CC-693 | 3.7.2 | Drug Product | 2.6 | HTML | 8,975 | Submitted | James O'Brien |
| CC-793 | 5.3.5 | Integrated Summary of Safety | 9.5 | Word | 7,037 | Active | Nadia Petrova |
| CC-893 | 1.3.9 | Proposed Conditions of Approval | 4.6 | Word | 10,912 | Active | James O'Brien |
| CC-993 | 4.7.8 | Genotoxicity | 10.6 | HTML | 11,547 | In Progress | Carlos Mendez |
| CC-1093 | 5.8.8 | Integrated Summary of Safety | 6.4 | HTML | 7,541 | Active | Marcus Webb |
| CC-1193 | 5.9.4 | Study Reports – Efficacy | 12.7 | XML | 4,626 | Approved | Carlos Mendez |
| CC-1293 | 2.9.3 | Clinical Summary | 7.2 | Word | 10,873 | Overdue | Tomoko Ikeda |
| CC-1393 | 3.6.9 | Analytical Methods | 10.0 | HTML | 9,631 | Approved | Carlos Mendez |
| CC-1493 | 2.2.7 | Quality Overall Summary | 5.2 | XML | 8,932 | Active | Aisha Okonkwo |
| CC-1593 | 4.2.7 | Pharmacology Studies | 1.2 | XML | 3,330 | Active | Marcus Webb |
| CC-1693 | 4.1.7 | Carcinogenicity | 11.8 | Word | 3,505 | Blocked | James O'Brien |
| CC-1793 | 2.3.9 | Nonclinical Summary | 4.3 | XML | 11,854 | Draft | Aisha Okonkwo |
| CC-1893 | 1.8.7 | Application Form | 12.8 | HTML | 10,502 | Approved | Priya Sharma |
| CC-1993 | 3.6.9 | Container Closure System | 7.8 | HTML | 12,055 | Completed | Priya Sharma |
Showing 20 of 20 components