Dossier DOS-045
Dossier in CTD format, version 4.7.4, for application ANVISA-2020-0045. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-045
Format
CTD
Version
4.7.4
Status
Pending
Application
Created
2022-08-31
Updated
2023-12-08
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 10 | Submitted |
| 2 | CTD Summaries | 8 | Submitted |
| 3 | Quality | 7 | Blocked |
| 4 | Nonclinical Study Reports | 15 | Active |
| 5 | Clinical Study Reports | 12 | In Progress |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-045 | 2.3.4 | Clinical Summary | 2.3 | XML | 5,042 | Failed | Nadia Petrova |
| CC-145 | 5.6.3 | Integrated Summary of Efficacy | 10.2 | 10,818 | Active | Sarah Chen | |
| CC-245 | 5.5.5 | Integrated Summary of Safety | 10.7 | 4,257 | Completed | James O'Brien | |
| CC-345 | 1.1.1 | Application Form | 1.6 | XML | 8,928 | Blocked | Marcus Webb |
| CC-445 | 3.5.5 | Manufacturing Process | 6.7 | HTML | 7,796 | Draft | James O'Brien |
| CC-545 | 5.2.8 | Integrated Summary of Efficacy | 12.0 | XML | 8,420 | Overdue | James O'Brien |
| CC-645 | 4.8.2 | Carcinogenicity | 8.5 | 11,370 | Completed | Dmitri Volkov | |
| CC-745 | 2.9.1 | Clinical Summary | 9.3 | 7,149 | Blocked | Tomoko Ikeda | |
| CC-845 | 2.4.6 | Nonclinical Summary | 5.3 | Word | 6,903 | In Progress | Sarah Chen |
| CC-945 | 5.9.7 | Study Reports – Clinical Pharmacology | 5.9 | 846 | Active | Priya Sharma | |
| CC-1045 | 1.3.8 | Application Form | 4.3 | Word | 836 | Draft | Aisha Okonkwo |
| CC-1145 | 3.1.9 | Stability Data | 6.7 | Word | 3,116 | Approved | Lieselotte van der Berg |
| CC-1245 | 2.4.2 | Clinical Summary | 10.9 | 2,069 | Overdue | Tomoko Ikeda | |
| CC-1345 | 3.7.7 | Container Closure System | 2.2 | Word | 12,137 | In Progress | Carlos Mendez |
| CC-1445 | 1.9.5 | Application Form | 12.4 | 11,078 | Draft | Carlos Mendez | |
| CC-1545 | 5.5.3 | Integrated Summary of Safety | 2.3 | XML | 10,551 | Draft | James O'Brien |
| CC-1645 | 4.6.7 | Pharmacology Studies | 10.6 | Word | 13,033 | Pending | Priya Sharma |
| CC-1745 | 4.5.4 | Toxicology Studies | 3.3 | Word | 10,193 | Failed | Nadia Petrova |
| CC-1845 | 2.7.7 | Clinical Overview | 5.5 | Word | 2,677 | Completed | Sarah Chen |
| CC-1945 | 1.8.3 | Prescribing Information | 3.3 | XML | 7,381 | Submitted | Marcus Webb |
Showing 20 of 20 components