Dossier DOS-015
Dossier in CTD format, version 7.7.8, for application ANMAT-2020-0015. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-015
Format
CTD
Version
7.7.8
Status
Pending
Application
Created
2023-02-03
Updated
2023-04-10
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 15 | Overdue |
| 2 | CTD Summaries | 4 | Approved |
| 3 | Quality | 9 | Pending |
| 4 | Nonclinical Study Reports | 5 | Draft |
| 5 | Clinical Study Reports | 8 | Overdue |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-015 | 1.4.6 | Cover Letter | 6.5 | Word | 9,909 | Active | James O'Brien |
| CC-115 | 2.1.7 | Nonclinical Overview | 4.1 | Word | 14,021 | Overdue | Marcus Webb |
| CC-215 | 3.2.8 | Stability Data | 9.3 | 9,898 | Active | Priya Sharma | |
| CC-315 | 3.7.3 | Appendices | 6.9 | 11,731 | Submitted | Priya Sharma | |
| CC-415 | 3.7.5 | Drug Substance | 3.0 | Word | 13,327 | Draft | Nadia Petrova |
| CC-515 | 4.6.7 | Carcinogenicity | 5.2 | HTML | 13,757 | Completed | Aisha Okonkwo |
| CC-615 | 5.7.8 | Integrated Summary of Efficacy | 6.1 | HTML | 9,293 | Approved | Dmitri Volkov |
| CC-715 | 2.9.1 | Nonclinical Overview | 7.7 | Word | 3,131 | Overdue | Lieselotte van der Berg |
| CC-815 | 2.5.3 | Quality Overall Summary | 2.9 | 13,161 | Failed | Lieselotte van der Berg | |
| CC-915 | 3.5.4 | Container Closure System | 6.1 | Word | 11,941 | Failed | Carlos Mendez |
| CC-1015 | 2.6.1 | Clinical Summary | 4.6 | HTML | 13,743 | In Progress | Tomoko Ikeda |
| CC-1115 | 1.1.9 | Proposed Conditions of Approval | 7.6 | 8,991 | Approved | Nadia Petrova | |
| CC-1215 | 5.2.5 | Study Reports – Efficacy | 3.5 | Word | 9,387 | Overdue | Priya Sharma |
| CC-1315 | 1.8.7 | Prescribing Information | 10.4 | XML | 14,875 | Draft | Tomoko Ikeda |
| CC-1415 | 5.5.5 | Integrated Summary of Safety | 12.7 | Word | 6,724 | In Progress | Dmitri Volkov |
| CC-1515 | 4.2.3 | Toxicology Studies | 7.9 | Word | 3,784 | Approved | Tomoko Ikeda |
| CC-1615 | 1.3.9 | Application Form | 12.5 | Word | 12,592 | Submitted | Tomoko Ikeda |
| CC-1715 | 1.2.1 | Patient Labeling | 1.8 | HTML | 7,458 | Draft | Marcus Webb |
| CC-1815 | 2.8.1 | Clinical Overview | 4.2 | Word | 13,755 | Draft | Tomoko Ikeda |
| CC-1915 | 2.6.9 | Nonclinical Overview | 11.4 | 6,413 | Completed | Nadia Petrova |
Showing 20 of 20 components